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Hovione has expanded its continuous tableting capacity with a state-of-the-art manufacturing facility at its site in Loures, Portugal. Portuguese pharmaceutical contract development and manufacturing company Hovione has built a state-of-the-art continuous tableting manufacturing facility at its existing site in Loures, Portugal, to expand its continuous manufacturing offering and services. The company invested $70m to develop the facility, which is part of its broader $170m investment programme to increase its production capacity by around 25% by 2023. The investment will enable Hovione to develop differentiated and empowering capabilities and assets to meet customers’ specific requirements for manufacturing oral dosage forms. The new drug manufacturing facility came online in September 2022.   Details of the pharmaceutical facility expansion Hovione Loures was expanded with a manufacturing building and eight-lab quality control facility. The company also upgraded its labs with the tools required to support the drug product lifecycle to ensure competency and capacity through research and development (R&D) to the production stage. In addition, it established an experienced, multi-disciplinary global team in continuous tableting to further improve its capabilities. Hovione has designed a commercial continuous tableting platform that facilitates key control requirements and offers operational ease, mechanistic modelling, and appropriate process analytical technology to its customers. The features of its quality system include automated in-process controls, real-time release deployment, and compliant digital infrastructure. These are designed to support the release of continuous tableting products. The company’s technology offers features and benefits such as faster development of simpler processes, rapid manufacturing of variable demand, strong control strategies and high process quality standards.   Details of Hovione’s existing site in Loures Hovione’s existing manufacturing plant at Loures has been operational since 1969 and has been continuously upgraded by adding new facilities. The plant was first approved by the US Food and Drug Administration (FDA) in 1982 and is inspected regularly. The manufacturing plant supports the development, piloting and full commercialisation of drug substances and product intermediates. It has an extensive capacity of 430m³ of vessels, ranging from 50lt to 14,000lt, along with a complete range of spray dryers with sizes ranging from lab-scale to industrial sizes. The site also features highly potent active pharmaceutical ingredient (API) handling, cryogenic, hydrogenation, corticosteroid, and potent spray-drying capabilities. It is staffed by highly skilled and experienced process development and analytical development teams that assist with the drug substance and particle engineering disciplines. The plant and the quality control labs operate 24 hours a day, seven days a week. The Loures site has been certified by the Health, Safety and Environment Management System in compliance with OHSAS18001 and ISO14001. It is also a certified Authorised Economic Operator.   Marketing commentary on Hovione Established in 1959, Hovione is an integrated contract development and manufacturing company (CDMO) with more than 60 years of experience. It offers services for drug substances, drug product intermediates and drug products. The company currently operates four FDA-inspected facilities in the US, China, Ireland and Portugal, as well as development laboratories in Lisbon, Portugal, and New Jersey, US. The opening of Hovione’s first manufacturing plant in Loures, Portugal, in 1969 was followed by its second manufacturing site in Macau, China, in 1986. The company subsequently opened plants in New Jersey in 2001 and Cork, Ireland, in 2009. Under the company’s $170m investment programme, Hovione is investing $50m in its manufacturing facility in East Windsor, New Jersey. This expansion will add two spray dryers to the facility and triple its capacity, as well as expand its capacity for research and small-scale API production. The company is investing a further $50m to add a spray dryer and upgrade its high-potency API production in Cork, Ireland, as part of the investment programme.   Read the full article at Pharmaceutical-Technology.com      

Article

Hovione’s Continuous Manufacturing Facility, Loures, Portugal

Oct 10, 2022

Hints of new science emerge in a field of growth for pharmaceutical services firms.   Earlier this year, Hovione announced a partnership with a Danish firm that has developed a whey protein–based excipient meant to enhance spray-dry dispersions. Hovione saw in Zerion Pharma’s Dispersome a means of advancing its services addressing bioavailability in drug formulation. Zerion, launched in 2019, saw a clear advantage in teaming with a well-established pharmaceutical services firm recognized as a leader in spray-drying services. A few months later, Nanoform Finland, a nanoparticle engineering specialist based in Helsinki, announced a partnership with the specialty drug firm Pharmanovia, which will apply Nanoform’s nanoparticle technology and formulation know-how to improve the bioavailability of drugs in its product line. Zerion and Nanoform are among the growing number of firms trying to deal with problems related to drug bioavailability. Their approaches are welcomed by industry observers, given the increased urgency of such problems and the relative sparsity of technological innovation.   Bioavailability, a measure of the portion of an active drug substance that enters the body’s circulation and affects the drug’s target, may not be the steepest challenge faced by developers of new therapeutic compounds. But it may well be the most pervasive. By many estimates, 70–90% of new small-molecule oral drugs have problems related to solubility and absorption. These problems have been exacerbated in recent years by the increasing complexity of drug molecules, especially in the oncology arena, according to Peter Bigelow, president of xCell Strategic Consulting. The speed with which innovators need to move forward in development has also resulted in a growing market for particle engineering and design, he says.   “Because speed is kind of the most important objective of so many of these programs, changing the chemistry is not something they have the luxury to do,” Bigelow says. “A sponsor company will say, ‘I can’t take a year off to come up with a new synthetic route. So you’ve got to make this route to work.’ ” Bioavailability services first emerged among providers specializing in formulation rather than at contract development and manufacturing organizations (CDMOs), whose primary service centers on the manufacture of active pharmaceutical ingredients (APIs). But the field has shifted over the last decade with the broadening of service offerings among CDMOs and the emergence of a one-stop-shop approach.   BEYOND API MANUFACTURE One of the most popular techniques for improving bioavailability is spray drying, a method for converting poorly soluble APIs into an amorphous dispersion by dissolving the API and a polymer exipient in an organic solvent and evaporating the solvent with heated gases. Hovione was an early adopter, investing in its first spray-drying capacity in 2004, but not with an eye toward improving bioavailability of customers’ drug candidates. “This is a good example of taking the right decision for the wrong reason,” says Guy Villax, who stepped down as CEO of the family-owned company earlier this year but remains on its board. “I was out in the market looking for business. I came across two inquiries that needed spray drying. We decided if customers were ready to make commitments, we were willing to invest.”   "To be successful you need more than the hardware." - Filipe Gaspar, chief technology officer   The contracts involved work on Captisol, a solubilizing agent whose manufacture required spray drying as an isolation technique. “There was nothing strategic in terms of addressing poorly soluble molecules,” Villax recalls. But as a result of those early contracts, Hovione was in position to provide solubility services—notably for hepatitis C drugs—as the market grew. Hovione significantly increased its spray-drying capacity in 2009, when it acquired a Pfizer plant in Cork, Ireland, that included what at the time was the world’s largest solvent-based pharmaceutical spray-drying tower. Other CDMOs have added services more recently. Fabbrica Italiana Sintetici (FIS) adopted spray drying in 2017, when it opened a new facility at its headquarters plant in Montecchio, Italy. FIS also provides micronization, a process of physically and mechanically breaking up drug crystals, and lyophilization, a freeze-drying means of manipulating particle size. Its sister company, Brenta, is a nanotechnology specialist offering formulation services that address API absorption and bioavailability. “FIS is a drug substance manufacturer; we are not in drug product,” says Luca Parlanti, the firm’s marketing director, using industry terms for active chemicals and finished drugs. “However, we recognized the increasing relevance of particle-size solid-state technology in general. It is important for a provider like ourselves to offer a forward integration into areas that bridge drug substance and formulation.” Particle engineering is a method of addressing not only bioavailability but also processability, Parlanti says, “because solid-state properties may impact the flow of a drug in the formulation process.”   BROAD PORTFOLIOS Lonza, one of the largest contract API manufacturers, has extended services into particle design via acquisition. The company acquired Capsugel, a formulation services specialist, in 2016, 3 years after Capsugel bought Bend Research, a leader in spray-dry dispersion services. The Capsugel deal also netted Lonza micronization services, but the Swiss firm recently divested assets, notably a plant in Quakertown, Pennsylvania, that was acquired by investors and set up on its own as Microsize. Lonza announced last month that it would introduce X-ray powder diffraction technology, an analytical tool to improve jet-milling micronization, at its formulation services operation in Monteggio, Switzerland. The company’s sale of the Pennsylvania plant is the latest transaction for a business dating back to 1994, when it began as Powdersize. It changed hands twice—purchased first in 2013 by Microsize’s current CEO, TJ Higley, and then by Capsugel. Higley left after the Lonza acquisition and returned to head the company this year. Higley says Microsize maintains its heritage of micronization, which he characterizes as a first line of attack in addressing bioavailability. He says the advantages of micronization include ease of process development and scale-up, an increase in particle surface area, processing at ambient temperatures, and overall low cost compared with its primary alternative, spray drying. Higley sees Microsize in a strong position. “The market is capacity constrained,” he says. “There is plenty of work out there, plenty of demand.” Some drugmakers have responded by setting up in-house particle design centers, “but there are huge limitations because people aren’t experts at it.” Nor are the in-house facilities typically capable of processing APIs from gram scale up to clinical and commercial scale, he says. “I would say people are bringing early, small-scale micronization in-house,” Higley says. “So, at some point they are going to need to outsource.” Catalent, another big services firm that has amassed particle design services, has bioavailability assets that date back nearly a century. “Catalent has been in the business of increasing oral bioavailability for oral delivery of active ingredients since the RP Scherer business was formed in 1933,” says Cornell Stamoran, vice president of corporate strategy, referring to a company formed by Robert Pauli Scherer, inventor of the rotary die encapsulation process used to formulate soft gelatin capsules. “I have a lab notebook in my office of one of the first R&D people on their second or third project, which was increasing bioavailability of fish oil.” Scherer was purchased in 1998 by Cardinal Health, which spun out its pharmaceutical services business as Catalent in 2007. Catalent has since acquired Pharmatek Laboratories, a drug services firm with spray-drying capabilities, and Juniper Pharmaceuticals, an expert in spray drying, nanomilling, and hot-melt extrusion—a method of melting a substance and forcing it through a die to form a new structure; it is widely employed in plastics and has more recently been adapted to pharmaceutical particle design applications. Thermo Fisher Scientific, a pharmaceutical services firm that took a leadership position in formulation services with the acquisition of Patheon in 2017, has also built a portfolio of bioavailability technologies. It added small-scale spray-drying dispersions with the purchase of Agere Pharmaceuticals in Bend, Oregon, which was formed in 2016 by the former CEO of Bend Research. Thermo Fisher added commercial-scale spray drying at a plant in Florence, South Carolina, shortly after acquiring the site from Roche in 2016. The Roche site also added micronization to Thermo Fisher’s tool kit. And the company invested in small-scale hot-melt extrusion capacity in Bend before scaling up the technology at its plant in Cincinnati. Both Catalent and Thermo Fisher have introduced systems to assess the most effective approach to formulation in early-stage drug development, including the selection of techniques to address bioavailability. Catalent has a program, OptiForm, that is based on a predictive modeling regimen it acquired from GSK in 2010. And Thermo Fisher introduced a predictive modeling tool, called Quadrant 2, that guides drug developers in choosing particle design approaches.   NEW WAVE Meanwhile, there are indications that improved approaches are coming to the market. Based on research that began at the University of Copenhagen, Zerion has developed a technology that uses proteins to increase small-molecule drug solubility and that constitutes an alternative to known polymer excipients in spray-dry dispersion applications. “We researched all sorts of different materials, including mesoporous silica, amino acid peptides, and cellulose nanofibers and eventually also proteins,” says Korbinian Löbmann, who is now Zerion’s chief science officer. The firm zeroed in on proteins. “We tested all the different proteins we could get our hands on, and out of all that research we identified that whey proteins worked particularly well not only for amorphous stabilization but also solubility enhancement,” Löbmann says. The whey protein also allowed significantly higher drug loading—up to 70% of the weight of the particle as opposed to an industry standard of 30% at the high end. Researchers filed a patent on behalf of the university and formed Zerion. The company has a partnership with Arla Food Ingredients, a specialist in whey protein processing that has developed a means of purifying β-lactoglobulin from whey protein isolate, for which the largest market is infant formula. Interest in the protein excipient Dispersome has materialized, says Zerion CEO Ole Wiborg, and the firm now has contracts with four major drug companies. And then there is the partnership with Hovione. “We were approached by Hovione, and this was very positive,” Wiborg says. We could see there was a lot of synergy between what we offer and what Hovione offers. And Hovione is, if not the best, then one of the best at spray-dry amorphous dispersion.” Moreover, Wiborg says, Hovione opens the door to small and midsize companies, the primary pharmaceutical innovators, which have been more difficult to identify and connect with than the majors. Hovione also sees benefits for both partners, whereby it gets access to a sophisticated new technology and boosts market access for a start-up, says António Dinis, Hovione’s director of sales and marketing. The deal establishes Hovione as “the sole partner for promoting the technology into the pharma marketplace,” he says. The arrangement is the first in which Hovione has gained new technology through a partnership, he adds. It may not be the last, given the industry’s problems with bioavailability. “Hovione is actively pursuing opportunities to enhance our technology offering to address these problems,” Dinis says. “Hovione will from now on be much more open to partnering with companies that help us bring more solutions to our customers.” Nanoform, which spun out of the University of Helsinki in 2015, has innovated a nanocrystalization approach to particle design by employing supercritical carbon dioxide. The company’s controlled expansion of supercritical solution technology produces particles as small ​as 10 nm but more typically within a range of 100–300 nm without the use of solvents, excipients, or polymers. The technology works by dissolving APIs in supercritical CO2 and controlling the pressure through a flow process to achieve supersaturation, which leads to crystallization or precipitation, according to Christopher Worrall, Nanoform’s vice president of US business development. The reduced size increases particles’ surface area, thereby increasing the dissolution rate and thus bioavailability. Nanoform signed its first contract last year for a drug produced according to the Finnish Medicines Agency Fimea's good manufacturing practice standards and has a goal of signing three such contracts this year.   TWEAKS AND TRANSFORMATION Despite the paucity of wholly new approaches to particle design, efforts are underway to improve workhorse approaches such as spray drying. Deanna Mudie, a principal scientist at Lonza’s operation in Bend, says Lonza has been experimenting with methods to facilitate amorphous dispersion of so-called brick-dust APIs—poorly soluble drugs with high melting points. “When drugs have poor solubility in organic spray-dry solvents, you end up with a very low throughput and also high organic solvent usage, which of course is not environmentally friendly,” Mudie says. One approach is to install a heat exchanger before the spray-drying step to increase a drug’s solubility in an organic solvent. The company is also applying environmentally friendly solvents, such as acetic acid, to processes to reduce the use of standards such as acetone, methanol, and in some cases environmentally impactful solvents such as dichloromethane. “In general, we have had that focus on improving spray drying over the last 5 years,” Mudie says. “There is a big push because we have seen a trend toward the brick-dust APIs.” While CDMOs have tended to bring on board tried-and-true methodologies for addressing bioavailability, adding such services can have a transformative impact. At Hovione, research in particle design has grown from a small research group of five chemists in 2005 to a multidisciplinary division with 70 scientists, including chemists, chemical engineers, biologists, and mathematicians.   “To be successful you need more than the hardware,” says Filipe Gaspar, Hovione’s chief technology officer and head of its particle design group. “You need the software, the people, the knowledge in R&D, the marketing effort. It is the coordination of a lot of disciplines.”   And innovation in particle design, as well as the customer engagements that arise as a result, aims CDMOs toward broader activity in services downstream from API manufacturing. Last month, Hovione announced the start of a new continuous tableting operation at its site in Loures, Portugal. Dinis sees a continuity in the growth of services. “A hundred percent of the powder we process in tableting comes out of spray drying,” he says. “If we weren’t working in spray drying, we would not be involved in tableting.”   Read the entire article at CEN.ACS.org    

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Making drugs more bioavailable

Sep 25, 2022

Portuguese pharmaceutical company Hovione has announced a “state-of-the-art, continuous manufacturing facility” is set to come online at its Loures site in Portugal. The company has also established a multi-disciplinary global team in continuous tableting, while upgrading its labs with the tools needed to support the drug product lifecycle. Jean-Luc Herbeaux, Hovione’s CEO, said: “Hovione has been historically focused on innovative technologies that benefit our customers and patients. With this investment in continuous tableting, our customers can rely on our support to bring much needed medicines to the market as fast as possible with the highest quality and manufacturing standards.” Herbeaux added: “We are investing to accelerate the adoption of this technology as we continue to innovate and enhance our offering around our areas of expertise.” "This investment in continuous tableting from R&D to production further strengthens Hovione´s CDMO offering" The technology offers advantages including faster development of simpler processes, manufacturing for variable demand, control strategies and high process quality standards. Filipe Neves, Hovione´s Strategic Business Director, said: “This investment in continuous tableting from R&D to production further strengthens Hovione´s CDMO offering and responds to the growing customer interest.” Continuous manufacturing is expected to change the landscape of drug product development and commercial production. The Food and Drug Administration (FDA) is partnering with the International Council for Harmonisation and leading a global initiative to advance continuous manufacturing of small molecules and other pharmaceutical modalities.   Read the full article at ManufacturingChemist.com     Learn more about Continuous Tableting at Hovione  

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Hovione expands manufacturing with continuous manufacturing facility

Sep 07, 2022

Lisbon, 6th September 2022 – Hovione, the leader in spray drying and particle engineering, announced today that it has expanded its continuous manufacturing offering and services. A new state-of-the-art continuous manufacturing facility is now coming online at the Loures site in Portugal. In addition, to support Hovione’s commitment to providing access and services for continuous tableting, Hovione has further strengthened its capabilities by establishing a highly experienced multi-disciplinary global team in continuous tableting and upgrading its labs with the tools needed to support the drug product lifecycle, thereby further guaranteeing competency and capacity from research & development to commercial production.   Continuous manufacturing is expected to change the landscape of drug product development and commercial production. The Food and Drug Administration (FDA) is partnering with the International Council for Harmonization and leading a global initiative to advance continuous manufacturing of small molecules and other pharmaceutical modalities. Hovione is offering customers a commercial continuous tableting platform prepared to support key control needs and deliver on operational excellence, mechanistic modeling, and appropriate process analytical technology (PAT). Additionally, Hovione´s quality system has been designed to support the release of continuous tableting products through automated in-process controls, deployment of real time release, and compliant digital infrastructure. This cutting-edge technology offers a distinct set of features and advantages including faster development of simpler processes, agile manufacturing for variable demand, robust control strategies and high process quality standards.  “Hovione has been historically focused on innovative technologies that benefit our customers and patients. With this investment in continuous tableting, our customers can rely on our support to bring much needed medicines to the market as fast as possible with the highest quality and manufacturing standards.”, comments Jean-Luc Herbeaux, Hovione´s CEO. “We are investing to accelerate the adoption of this technology as we continue to innovate and enhance our offering around our areas of expertise.”   “This investment in continuous tableting from R&D to production further strengthens Hovione´s CDMO offering and responds to the growing customer interest.” says Filipe Neves, Hovione´s Strategic Business Director.  This latest investment in Continuous Tableting is part of Hovione´s broader strategy to build differentiated and enabling capabilities and assets to meet customers unique needs for oral dosage forms manufacturing.   About Hovione: Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solution across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.  

Press Release

Hovione expands drug product offering with a new manufacturing line dedicated to Continuous Tableting

Sep 06, 2022

Lisbon 23rd of August 2022, Hovione and Zerion Pharma A/S (Zerion) today announced an extension of their collaboration on Zerion’s Dispersome® technology into the nutraceutical/dietary supplements field. Many dietary supplements suffer from low solubility. This results in poor bioavailability and consequently limits the physiological effect of the supplement. To overcome these limitations, the two companies will collaborate and apply the solubility enhancing Dispersome® technology for the development and commercialization of certain nutraceutical products.    The first product candidate selected for joint development is an antioxidant with multiple health benefits and known for its extremely low solubility and bioavailability. By applying the Dispersome® technology, Zerion has been able to demonstrate significant solubility improvements of this antioxidant. Under their collaboration, Hovione and Zerion will now upscale and develop commercial formulations of the antioxidant using the Dispersome® platform and make these products available for distribution by partners globally. Under the terms of the collaboration agreement, the two companies will share income from the commercialization of these products according to their respective contributions.    In addition to the joint development projects, Zerion has granted Hovione an exclusive license to exploit the Dispersome® technology for other nutraceuticals/dietary supplements. In return, Hovione will pay Zerion license fees and royalties on sales of the licensed products.    “The low oral bioavailability of some of the health-promoting nutraceutical compounds is a well-known challenge. The problem is compounded by the fact that some of the solutions used in pharma cannot be used in foods.” says Jean-Luc Herbeaux, CEO of Hovione. He adds: “Hovione is thrilled to be Zerion´s exclusive partner for the application of Dispersome® to the fields of nutraceuticals and dietary supplements. The Dispersome® platform and its enabling ingredient – beta-lactoglobulin or BLG – afford formulators new options which address unmet needs of the industry.”     “I am extremely pleased with this extension of our collaboration”, says Ole Wiborg, CEO of Zerion and continues: “The Dispersome® technology is actually very well suited for use in dietary supplements because it employs BLG as its solubility enabling component. BLG is a sustainable natural material and in itself a beneficial nutritional product that we source in high quality from Arla Food Ingredients. Since we as a company only have limited resources to exploit these promising applications of the Dispersome® technology in the nutraceutical field, the collaboration with Hovione is a win/win situation.”   In February 2022, Zerion and Hovione announced a strategic partnership aimed at commercializing the Dispersome® technology within the drug development field. Under this partnership, Hovione and Zerion are offering pharma and biotech companies worldwide access to an innovative drug delivery platform combined with an unparalleled experience in formulation development, scale up and GMP manufacturing. This unique combination provides customers in the pharma industry with a line of sight over the entire drug development life cycle from the preclinical phase to commercial drug product.   About Hovione: Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solution across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.   About Zerion Pharma ApS: Zerion develops proprietary drug formulations and offers the Dispersome® technology to established pharma companies as a means to solve their most challenging drug solubility problems. By applying the Dispersome® technology, the solubility of poorly soluble, oral drugs is greatly enhanced, which improves their bioavailability and therapeutic outcomes for the patients. Zerion was established in 2019 as a spinout from the University of Copenhagen based on almost a decade of research. (Dispersome® is a trademark of Zerion Pharma A/S)   Learn more about Dispersome® technology  

Press Release

Zerion Pharma and Hovione extend partnership to cover use of the Dispersome® technology platform in nutraceuticals

Aug 23, 2022

Last week, in an effort to increase energy security in the European Region and prepare for possible disruptions of gas supplies from Russia, the European Union (EU) member states reached a political agreement on a voluntary reduction of natural gas demand by 15% this winter. To respond to this engagement, each Member State will need to define the measures it will adopt between the 1st of August 2022 and the 31st of March 2023. To reflect the individual situations of Member States, some exceptions are expected, however, at this date details are still unknown.    Although we do not expect the Hovione manufacturing operations to be affected, it is not unreasonable to expect that some of our suppliers of raw and starting materials may be impacted.  We are therefore preparing a risk mitigation plan, which includes strengthening our supply chain to reduce the impact that any disruption may have on our activity.    One option we decided to offer to our customers is to purchase raw materials early and store them closer to our manufacturing site. If you are interested in exploring this option or have questions or alternate proposals, please contact your Account Manager.    As your partner, we are committed to employing our best efforts to mitigate any serious impact that might get in the way of our delivering the products and services requested by our customers.   Thank you for your trust and collaboration through these unprecedented challenges.    Patients need us. We are In it for life.      

News

Approved gas reduction in the EU

Aug 08, 2022

On July 9th, 2022, the Government of the Special Administrative Region of Macau issued the Executive Order No. 115/2022 ordering all industries and commercial businesses located in Macau to suspend operations and shut down from July 11th to July 18th as an extraordinary measure to contain the spread of COVID-19 in the community. In accordance with the executive order, the majority of businesses located in Macau are obliged to shut down from 00:00 on July 11th, 2022 to 00:00 on July 23rd, 2022, including Hovione's manufacturing facility located in the territory.    Since the start of the COVID-19 epidemic, Hovione has been employing procedures and rules to reduce and minimize the impact of forced shutdowns and closures to our manufacturing facilities. Although the temporary suspension of our activities in Macau is beyond the reasonable control of Hovione and mandated by the local government, we will continue to employ all measures to reduce and mitigate the impact of such Interruption on our activities, our customers and partners.    Some of the measures employed at this facility include building up safety stocks of raw materials and finished API, advancing shipment dispatch dates to those clients facing the highest risk of disruption, leveraging bonded warehouses to allow for continued supply of materials, among others.    We commit to immediately notifying you if there are any foreseeable disruptions that may impact your product. Should you have any questions feel free to reach out to your account manager who will be happy to support you.    In the meantime, we will continue to make safe our place of work in order to continue serving our clients and our communities the best we can as we are In it for life.           About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland, and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of and services, from API, formulation development and devices. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.        Find more about our site, Hovione Macau          

News

Communication of Site Shutdown - Hovione Macau

Jul 18, 2022

Video - We are the Second Line of Defense To watch the video with subtitles, choose your language:  PT  |  CN  |  EN   English     SARS-CoV-2: What & How Question: What is a virus? Answer: A virus is not a bacteria. A virus is a microorganism that causes damage in the body by invading cells (these cells are called hosts). Unlike bacteria, all viruses cause disease.   Question: What is the difference between a virus and a bacterium? Answer: Both bacteria and viruses are microorganisms. But think of it this way: an elephant and a rat are completely different but they’re both animals. Same goes for the virus and bacteria. Additionally, one of the biggest differences between bacteria and viruses, is their size. A bacterium is the size of a large orange, in comparison to a virus which would be the size of an apple seed.   Question: How is Covid-19 transmitted? Answer: The main route of transmission is through respiratory droplets. We expel these when we sneeze, cough or even when we talk! Another common route includes touching surfaces that have the virus and then touching your face (before washing your hands). Find more in this article published in Elsevier   Question: Can a virus live on non-living surfaces? Answer: Yes. Although viruses live off of other organisms, such as animals or plants, they can be found on non-living surfaces. However, a virus cannot survive for a very long time on non-living surfaces. Find more on The New England Journal of Medicine   Question: How long does the virus last on surfaces? Answer:      Food: no evidence to suggest it spreads through food Paper: from a few minutes up to 5 days Cardboard: ~ 24 hours Wood: ~ 4 days Plastic: ~ 2/3 days Metals:  ~ 5 days Steel: ~ 2/3 days   The overall survival rate of the virus on surfaces may vary slightly according to the amount of sunlight and humidity the virus gets exposed to. Find more on The New England Journal of Medicine   Question: Will warm weather stop the outbreak of Covid-19? Answer: It is not yet known whether weather and temperature affect the spread of Covid-19. Some other viruses, like those that cause the common cold and flu, spread more during cold weather months but that does not mean it is impossible to become sick with these viruses during other months.  There is much more to learn about the transmissibility, severity, and other features associated with Covid-19 and investigations are ongoing. Find more at CDC.gov   Question: Can someone who has been quarantined for Covid-19 spread the illness to others? Answer: Quarantine means separating a person or group of people who have been exposed to a contagious disease but have not developed illness (symptoms) from others who have not been exposed, in order to prevent the possible spread of that disease. Quarantine is usually established for the incubation period of the communicable disease, which is the span of time during which people have developed illness after exposure. For Covid-19, the period of quarantine is 14 days from the last date of exposure because the incubation period for this virus is 2 to 14 days. Someone who has been released from Covid-19 quarantine is not considered a risk for spreading the virus to others because they have not developed illness during the incubation period. Find more at CDC.gov   Question: How does Covid-19 affect our cells? Answer: Covid-19 is particularly good at sticking to respiratory tissue. This means attaching to cells found mainly in the lungs. The virus does this by using its crown-like spikes which are attached to the virus’ envelope. As a result, one virus particle can attach itself to multiple cells in the body.       The easiest paths of entry for the virus are the mouth, nose and eyes. Once the virus manages to attach itself to the host cell, the host cell will take the virus particle in. The virus will then release genetic information called RNA. RNA acts as a set of instructions that tells the host cell what to do. Therefore, RNA will stop a cell from functioning normally, and instead will convert the healthy host cell into a virus making factory. Once the new virus is assembled inside the host cell, it is released into the surroundings, hence causing even further infection in the body. If our immune system is not effective at fighting the virus and stopping it from spreading onto further cells, more virus-making factories are created in our body using our cells. This eventually kills the host cell, as it is starved by the virus, causing us to have severe respiratory problems, amongst other consequences.   Question: Why do we need to use facemasks? Answer: Facemasks reduce the distance respiratory particles can travel. This means that it reduces the chances of getting infected by preventing the spread of respiratory droplets. It also acts as a filter to the air you breath in and so prevents you from inhaling the virus. Find more at CDC.gov   Question: How does washing our hands with soap, get rid of the virus? Answer: Soap is crucial as it contains chemicals that break down the layer of fat surrounding the coronavirus (envelope) and hence completely destroy it. Using only water doesn’t help because it doesn’t stop the virus from sticking to your hand. Watch this video to learn how soap kills the coronavirus   Question: Why should you avoid touching your face? Answer: This is because the virus can easily enter the body through the mouth, nose or even eyes. However, the virus doesn’t enter your body through the skin, as this acts as a physical barrier.  Find more at CDC.gov   Question: Should I take antibiotics to treat Covid-19 and are anti-bacterial products useful? Answer: Antibiotics are not designed to stop viral infections and therefore are of no use when trying to treat Covid-19. As explained above, bacteria and viruses are two very different microorganisms. This means that anti-bacterial products are not useful either, for when disinfecting surfaces from Covid-19. Instead you should use disinfectant or alcohol.   Question: Is the virus’ ability to spread affected by the climate? Answer: So far there is no scientific evidence to suggest or prove that the virus is less effective at spreading in hot or humid weather.   Question: What are the symptoms of Covid-19? Answer:  People with Covid-19 have had a wide range of symptoms reported – ranging from mild symptoms to severe illness. Symptoms may appear 2-14 days after exposure to the virus. People with these symptoms may have Covid-19: Fever or chills Cough Shortness of breath or difficulty breathing Fatigue Muscle or body aches Headache New loss of taste or smell Sore throat Congestion or runny nose Nausea or vomiting Diarrhea This list does not include all possible symptoms. CDC will continue to update this list as we learn more about Covid-19. Find more at CDC.gov   Question: Can someone test negative and later positive on a viral test for Covid-19? Answer:  Yes, it is possible. You may test negative if the sample was collected early in your infection and test positive later during this illness. You could also be exposed immune to Covid-19 after the test and get infected then. Even if you test negative, you still should take steps to protect yourself and others. See Testing for Current Infection for more information. Find more at CDC.gov   Question: If I have recovered from Covid-19, will I be immune to it? Answer: We do not know yet if people who recover from Covid-19 can get infected again. CDC and partners are investigating to determine if a person can get sick with Covid-19 more than once. Until we know more, continue to take steps to protect yourself and others. Find more at CDC.gov   Question: Who is at higher risk for serious illness from Covid-19? Answer: COVID-19 is a new disease and there is limited information regarding risk factors for severe disease. Based on currently available information and clinical expertise, older adults and people of any age who have serious underlying medical conditions might be at higher risk for severe illness from Covid-19. Based on what we know now, those at high-risk for severe illness from Covid-19 are: People aged 65 years and older People who live in a nursing home or long-term care facility People of all ages with underlying medical conditions, particularly if not well controlled, including: People with chronic lung disease or moderate to severe asthma People who have serious heart conditions People who are immunocompromised Many conditions can cause a person to be immunocompromised, including cancer treatment, smoking, bone marrow or organ transplantation, immune deficiencies, poorly controlled HIV or AIDS, and prolonged use of corticosteroids and other immune weakening medications People with severe obesity (body mass index [BMI] ≥40) People with diabetes People with chronic kidney disease undergoing dialysis People with liver disease Find more at CDC.gov   Question: What should people at higher risk of serious illness with Covid-19 do? Answer: If you are at higher risk of getting very sick from Covid-19, you should: Stock up on supplies Take everyday precautions to keep space between yourself and others When you go out in public, keep away from others who are sick Limit close contact and wash your hands often Avoid crowds, cruise travel, and non-essential travel If there is an outbreak in your community, stay home as much as possible. Watch for symptoms and emergency signs. If you get sick, stay home and call your doctor. More information on how to prepare, what to do if you get sick, and how communities and caregivers can support those at higher risk is available on People at Risk for Serious Illness from COVID-19. Find more at CDC.gov   Useful links httpss://www.youtube.com/watch?v=O-3Mlj3MQ_Q&feature=youtu.be httpss://www.youtube.com/watch?v=n6QwnzbRUyA&feature=youtu.be httpss://www.livescience.com/coronavirus-kids-guide.html httpss://www.natgeokids.com/au/discover/science/general-science/what-is-coronavirus/ httpss://www.youtube.com/watch?v=BE-cA4UK07c&feature=youtu.be httpss://www.journalofhospitalinfection.com/article/S0195-6701(20)30046-3/fulltext httpss://www.wjgnet.com/2307-8960/full/v8/i8/1391.htm   Relevant Information Hovione Practical Handbook - Covid-19 The Coronavirus Prevention Handbook Spanish Flu book chapter Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Provisional 6th Edition) At the time this was the best informed source on the Novel Coronavirus is probably PRC’s Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Provisional 6th Edition). This is an unofficial google translated version of the document (6th version) Report from WHO panel of international experts that just returned from a fact-finding mission to China – (25 February 2020) WHO-2019-nCoV-IPC - Water, sanitation, hygiene, and waste management for the COVID-19 virus EN - The WHO informs that in order to sanitize surface areas you can use a mixture of 0,5% of bleach (sodium hypochlorite) in water. Bleach bottles for household use indicate the concentration percentage in their labels - a bottle from Continente supermarket, for instance, indicates 5% - therefore to use this product to sanitize an area you need to dissolve it in water - one measuring cup of bleach for nine measuring cups of water will provide you with a solution containing 0,5% bleach. Be extremely careful when handling bleach with a 5% concentration. It can burn the skin. If it spills drops to the skin or eyes wash them immediately with abundant water for two minutes.  WHO-recommended Handrub Formulations   Rate of growth of COVID-19 SARS-Cov-2 Report - 30 November 2021   Hovione Crisis Response COVID-19 - Hovione Crisis Response COVID-19 Preparedness Response - Countermeasures adopted prior to Chinese New Year at the Hovione Macau plant    Stakeholders Communiqués Communication of Site Shutdown - Hovione Macau 15 July 2022 16th Stakeholder Communiqué Covid-19 11 May 2021 15th Stakeholder Communiqué Covid-19 12 March 2021 14th Stakeholder Communiqué Covid-19 5 February 2021 13th Stakeholder Communiqué Covid-19 12 January 2021 12th Stakeholder Communiqué Covid-19 7 December 2020 11th Stakeholder Communiqué Covid-19 5 November 2020 10th Stakeholder Communiqué Covid-19 8 October 2020 9th Stakeholder Communiqué - Covid-19 2 September 2020 8th Stakeholder Communiqué - Covid-19 12 August 2020 7th External Stakeholder Communiqué - Covid-19 9 July 2020 6th External Stakeholder Communiqué - Covid-19 8 June 2020 5th External Stakeholder Communiqué - Covid-19 6 May 2020 Covid-19 FAQ 20 April 2020 4th External Stakeholder Communiqué - Covid-19 3 April 2020 Covid-19 - An update from Hovione's CEO 20 March 2020 3rd External Stakeholder Communiqué - Covid-19 13 March 2020 2nd External Stakeholder Communiqué - Covid-19 12 February 2020 1st External Stakeholder Communiqué - Coronavirus 2019-NCoV 31 January 2020   Webinar   Webinar Presentation Sharing our Covid-19 experience. Seeking Feedback 14 July 2020     Service Providers and External Visitors Guidance Protocol for External Visitors   Contingency Plan - Covid-19   Videos We are the Second Line of Defense (27 April 2020) To watch the video with subtitles, choose your language:  PT  |  CN  |  EN   Message from Élie Vannier, Chairman of the Board of Directors (30 July 2020) Language: English and subtitles in Portuguese   Return From Home Rules (7 July 2020)   Message from Filipe Gaspar, Chief Technology Officer (7 April 2020) Language: Portuguese and subtitles in English     Message from Tiago Ferreira de Matos, General Counsel (31 March 2020) Language: Portuguese and subtitles in English     Guy Villax message - Washing hands (25 March 2020)     Message from Eddy Leong, Site Manager - Macao (23 March 2020) What can people do to protect themselves and others from getting the new coronavirus Source: WHO, World Health Organization   WHO: How to handwash? With soap and water Source: WHO, World Health Organization Can masks protect against the new coronavirus infection? Source: WHO, World Health Organization     Certifications     As a result of a joint effort between Hovione and Gertal, Sete Casas and Lumiar Canteens have been certified by APCER with the “Covid Safe Verified” seal. “Covid Safe” is a brand developed by APCER that certifies compliance with the new health and safety rules, in the context of the Covid-19 pandemic. This certification is the recognition of the concern of both Hovione and Gertal in complying with the rules established and providing the best safety conditions for our Team Members.     ABC Covid-19 (for schools) ABC Covid-19 initiative aims to help schools across the country in their return to classes in a practical, direct, and efficient way, by providing support to answer the various difficulties they face in their daily routines. The team is composed of trainees and is supervised by the Covid-19 prevention team at Hovione and their aim is to inform students about what are good habits to adopt and how to prevent risks while also supporting teachers and staff with up-to-date, reliable and clear information. Here you can find all the information provided in a poster format that you can distribute throughout the school. Portuguese only. Posters 01. Uso de Máscara A / Uso de Máscara 02. Uso de Máscara B  03. Retirar a Máscara 04. Regras para sair de casa 05. Recomendações 06. Proteção Covid-19 07. Lave as mãos com frequência 08. Lavagem de mãos / Lavagem de mãos 09. Lavagem de mãos com gel desinfetante 10. Como medir a temperatura 11. Medidas Gerais 12. Medidas Escolas 13. Utilização de Líxivia (1) 14. Utilização de Líxivia (2) 15. Instruções para Elevadores 16. Distanciamento Social 17. Desinfetar Superfícies     Follow us:               17-year arts student wins ABCovid contest Tomás Oliveira, aged 17, from Escola Artística António Arroio, with the video "Covid-19 simplified for morons", which explains simply and graphically why we need a mask to protect ourselves from this virus. The ABCovid contest is an initiative taken by Hovione trainees aimed at elementary and high school students. For more details visit www.abcovid.pt           Português   SARS-CoV-2: O Quê & Como Pergunta: O que é um vírus? Resposta: Um vírus não é uma bactéria. Um vírus é um microrganismo que causa danos ao organismo, invadindo as células (essas células são chamadas de hospedeiros). Ao contrário das bactérias, todos os vírus causam doenças.   Pergunta: Qual é a diferença entre um vírus e uma bactéria? Resposta: Bactérias e vírus são microrganismos. Mas pense assim: um elefante e um rato são completamente diferentes, mas ambos são animais. O mesmo vale para o vírus e as bactérias. Além disso, uma das maiores diferenças entre bactérias e vírus é o seu tamanho. Uma bactéria é do tamanho de uma laranja grande, em comparação com um vírus do tamanho de uma semente de maçã.   Pergunta: Como o Covid-19 é transmitido? Resposta: A principal via de transmissão é através de gotículas respiratórias. Nós os expulsamos quando espirramos, tossimos ou mesmo quando conversamos! Outra rota comum inclui tocar em superfícies com o vírus e depois tocar em seu rosto (antes de lavar as mãos). Saiba mais neste artigo científico publicado na Elsevier   Pergunta: Um vírus pode viver em superfícies não-vivas? Resposta: Sim. Embora os vírus vivam de outros organismos, como animais ou plantas, eles podem ser encontrados em superfícies não-vivas. No entanto, um vírus não pode sobreviver por muito tempo em superfícies não-vivas. Saiba mais neste artigo publicado na The New England Journal of Medicine   Pergunta: Quanto tempo dura o vírus nas superfícies? Resposta: Comida: nenhuma evidência para sugerir que ela se espalha através da comida Papel: de alguns minutos a 5 dias Papelão: ~ 24 horas Madeira: ~ 4 dias Plástico: ~ 2/3 dias Metais: ~ 5 dias Aço: ~ 2/3 dias A taxa geral de sobrevivência do vírus nas superfícies pode variar ligeiramente de acordo com a quantidade de luz solar e umidade à qual o vírus é exposto. Saiba mais neste artigo publicado na The New England Journal of Medicine   Pergunta: O tempo quente vai parar o surto de Covid-19? Resposta: Ainda não se sabe se o clima e a temperatura afetam a propagação do Covid-19. Alguns outros vírus, como os que causam o resfriado e a gripe comuns, se espalham mais durante os meses de clima frio, mas isso não significa que é impossível ficar doente com esses vírus durante outros meses. Há muito mais para aprender sobre a transmissibilidade, a gravidade e outros recursos associados ao Covid-19 e às investigações em andamento. Saiba mais no website CDC.gov    Pergunta: Alguém que foi colocado em quarentena por Covid-19 pode espalhar a doença para outras pessoas? Resposta: Quarentena significa separar uma pessoa ou grupo de pessoas que foram expostas a uma doença contagiosa, mas não desenvolveram doenças (sintomas) de outras que não foram expostas, a fim de impedir a possível propagação dessa doença. A quarentena é geralmente estabelecida para o período de incubação da doença transmissível, que é o período durante o qual as pessoas desenvolvem doenças após a exposição. Para o COVID-19, o período de quarentena é de 14 dias a partir da última data de exposição, porque o período de incubação desse vírus é de 2 a 14 dias. Alguém que foi liberado da quarentena de COVID-19 não é considerado um risco de espalhar o vírus para outras pessoas porque não desenvolveram doenças durante o período de incubação. Saiba mais no website CDC.gov   Pergunta: Como o Covid-19 afeta as nossas células? Resposta: O Covid-19 é particularmente bom em aderir ao tecido respiratório. Isso significa anexar às células encontradas principalmente nos pulmões. O vírus faz isso usando seus picos em forma de coroa, anexados ao envelope do vírus. Como resultado, uma partícula de vírus pode se conectar a várias células do corpo. Os caminhos mais fáceis de entrada para o vírus são a boca, nariz e olhos. Uma vez que o vírus consiga se conectar à célula hospedeira, a célula hospedeira absorve a partícula do vírus. O vírus libera informações genéticas chamadas RNA. O RNA atua como um conjunto de instruções que informa à célula hospedeira o que fazer. Portanto, o RNA interrompe o funcionamento normal da célula e, em vez disso, converte a célula hospedeira saudável em uma fábrica de criação de vírus. Uma vez que o novo vírus é montado dentro da célula hospedeira, ele é liberado para o ambiente, causando ainda mais infecções no organismo. Se nosso sistema imunológico não é eficaz no combate ao vírus e impede que ele se espalhe para outras células, mais fábricas de criação de vírus são criadas em nosso corpo, usando nossas células. Isso acaba matando a célula hospedeira, pois ela sofre de fome pelo vírus, causando problemas respiratórios graves, entre outras consequências.     Pergunta: Por que precisamos usar máscaras? Resposta: As máscaras faciais reduzem a distância que as partículas respiratórias podem percorrer. Isso significa que reduz as chances de ser infectado, impedindo a propagação de gotículas respiratórias. Também atua como um filtro para o ar que você respira e impede a inalação do vírus. Saiba mais no website CDC.gov   Pergunta: Como lavar as mãos com sabão elimina o vírus? Resposta: O sabão é crucial, pois contém produtos químicos que quebram a camada de gordura ao redor do coronavírus (envelope) e, portanto, o destroem completamente. Usar apenas água não ajuda, pois não impede que o vírus grude na sua mão. Assista a este vídeo para saber como é que o sabão elimina o vírus   Pergunta: Por que você deve evitar tocar no seu rosto? Resposta: Isso ocorre porque o vírus pode facilmente entrar no corpo pela boca, nariz ou até olhos. No entanto, o vírus não entra no seu corpo através da pele, pois atua como uma barreira física. Saiba mais no website CDC.gov   Pergunta: Devo tomar antibióticos para tratar o Covid-19 e os produtos antibacterianos são úteis? Resposta: Os antibióticos não são projetados para interromper infecções virais e, portanto, não são úteis ao tentar tratar o Covid-19. Como explicado acima, bactérias e vírus são dois microorganismos muito diferentes. Isso significa que os produtos antibacterianos também não são úteis, ao desinfetar superfícies do Covid-19. Em vez disso, você deve usar desinfetante ou álcool.   Pergunta: A capacidade do vírus se espalhar é afetada pelo clima? Resposta: Até o momento, não há evidências científicas para sugerir ou provar que o vírus é menos eficaz na propagação em clima quente ou úmido.   Pergunta: Quais são os sintomas da Covid-19? Resposta: Pessoas com Covid-19 tiveram uma ampla gama de sintomas relatados - desde sintomas leves a doenças graves. Os sintomas podem aparecer 2-14 dias após a exposição ao vírus. Pessoas com esses sintomas podem ter Covid-19: Febre ou calafrios Tosse Falta de ar ou dificuldade em respirar Fadiga Dores musculares ou corporais Dor de cabeça Nova perda de paladar ou olfato Dor de garganta Congestão ou coriza Náusea ou vômito Diarreia Esta lista não inclui todos os sintomas possíveis. O CDC continuará a atualizar esta lista à medida que aprendermos mais sobre o Covid-19. Saiba mais no website CDC.gov   Pergunta: Alguém pode testar negativo e posteriormente positivo num teste viral para o Covid-19? Resposta: Sim, é possível. Você pode ter um resultado negativo se a amostra foi coletada no início de sua infeção e um resultado positivo mais tarde durante esta doença. Você também pode ser exposto ao Covid-19 imune após o teste e infetado. Mesmo se você testar negativo, você ainda deve tomar medidas para proteger a si e aos outros. Consulte Teste para infecção atual para obter mais informações. Saiba mais no website CDC.gov   Pergunta: Se eu me recuperei do Covid-19, estarei imune? Resposta: Ainda não sabemos se as pessoas que se recuperam do Covid-19 de ficar doente com Covid-19 mais de uma vez. Até que saibamos mais, continue a tomar medidas para proteger a si e aos outros. Saiba mais no website CDC.gov   Pergunta: Quem está em maior risco de doenças graves por causa da Covid-19? Resposta: Covid-19 é uma doença nova e há informações limitadas sobre fatores de risco para doenças graves. Com base nas informações disponíveis no momento e nos conhecimentos clínicos, idosos e pessoas de qualquer idade com sérias condições médicas subjacentes podem estar em maior risco de doença grave por causa do Covid-19. Com base no que sabemos agora, aqueles com alto risco de doença grave por Covid-19 são: Pessoas com 65 anos ou mais Pessoas que vivem em um lar de idosos ou em instituições de longa permanência Pessoas de todas as idades com condições médicas subjacentes, principalmente se não forem bem controladas, incluindo: Pessoas com doença pulmonar crônica ou asma moderada a grave Pessoas que têm problemas cardíacos graves Pessoas imunológicas   Links Úteis httpss://www.youtube.com/watch?v=O-3Mlj3MQ_Q&feature=youtu.be httpss://www.youtube.com/watch?v=n6QwnzbRUyA&feature=youtu.be httpss://www.livescience.com/coronavirus-kids-guide.html httpss://www.natgeokids.com/au/discover/science/general-science/what-is-coronavirus/ httpss://www.youtube.com/watch?v=BE-cA4UK07c&feature=youtu.be httpss://www.journalofhospitalinfection.com/article/S0195-6701(20)30046-3/fulltext httpss://www.wjgnet.com/2307-8960/full/v8/i8/1391.htm   Informação Relevante Manual Prático Colaborador Hovione - Covid-19 Manual para a Prevenção e Tratamento da Covid-19 WHO-2019-nCoV-IPC - Water, sanitation, hygiene, and waste management for the COVID-19 virus Para desinfectar as superfícies a OMS recomenda uma solução (mistura) de 0,5% de lixívia (hipoclorito de sódio) em água. As embalagens de lixívia para uso doméstico indicam a concentração em % no rótulo - num exemplo do Continente vimos a indicação de 5% - daí que para conseguir ter uma concentração para desinfetar as superfícies com esse produto a 5% é preciso diluir com mais àgua:  a uma medida de lixívia a 5% juntar 9 medidas de água para ter uma solução a 0,5%. Cuidado com a lixívia, em concentrações de 5% ou mais causa queimaduras na pele. Se pingos forem para a pele ou os olhos lave abundantemente com água durante 2 minutos.   Webinar   Apresentação Webinar Resposta a Covid-19 - Partilha de experiências. Juntos somos mais fortes 16 julho 2020   Prestadores de Serviços Prestadores de Serviços: Plano de Contingência COVID-19   Regras de Circulação em Instalações Hovione em Sete Casas e Lumiar   Videos Hovione - Messagem de Élie Vannier, Presidente do Conselho de Administração (30 de julho 2020) Legendado em Português     ABCovid: Entrevista de Santiago Sampaio no programa Curto Circuito, SIC Radical (13 de julho 2020) Saber mais sobre o Concurso Nacional ABCovid   Mensagem de Ana Cristina Guimarães, Diretora de RH Portugal (26 de junho de 2020)   Mensagem de Isabel Jonet, Banco Alimentar Contra a Fome (5 de junho 2020)   Regras de Regresso de Casa (28 de maio de 2020)   Regras de Regresso de Casa - Regra 1   Regras de Regresso de Casa - Regra 2   Regras de Regresso de Casa - Regra 3   Regras de Regresso de Casa - Regra 4 e 5   Regras de Regresso de Casa - Regra 6   Regras de Regresso de Casa - Regra 7 Regras de Regresso de Casa - Regra 8   Regras de Regresso de Casa - Regra 9   Regras de Regresso de Casa - Regra 10   Regras de Regresso de Casa - Regra 11     Histórias de Superação (1 de maio de 2020)     Somos a segunda linha de defesa (27 de abril de 2020) Video disponível com legendas em  CN  |  EN       Mensagem de Filipe Gaspar, Chief Technology Officer (7 de abril de 2020)       Mensagem de Tiago Ferreira de Matos, General Counsel (31 de março de 2020)       Mensagem de Guy Villax - Lavagem de mãos (25 de março de 2020)     Mensagem de Guy Villax a partir da fábrica de Sete Casas em Portugal (19 de março de 2020)     Medidas internas coronavírus com procedimentos à chegada aos nossos sites (6 de março de 2020)   Recomendação de medidas de proteção individual e coletiva na prevenção da infeção com COVID-19 Fonte: DGS, Direção-Geral da Saúde   Prevenção e Proteção Fonte: DGS, Direção-Geral da Saúde     O novo coronavírus - COVID-19 Fonte: DGS, Direção-Geral da Saúde       Empresas alteram produção para fabricar desinfetantes Fonte: RTP1         Certificações Em resultado de um esforço conjunto entre a Hovione e a Gertal, as Cantinas de Sete Casas e do Lumiar foram certificadas pela APCER com o selo “Covid Safe Verified”. “Covid Safe” é uma marca desenvolvida pela APCER que certifica o cumprimento das novas regras de segurança e saúde, no contexto da pandemia da Covid-19. Esta certificação é o reconhecimento da preocupação da Hovione e da Gertal em cumprir as regras estabelecidas e em proporcionar as melhores condições de segurança aos nossos Colaboradores.   Notícias / Media Inspirar à ação… para uma saúde de qualidade (ODS 3) 29 janeiro 2021   ABC Covid-19 (para escolas) A iniciativa ABC Covid-19 visa ajudar as escolas de todo o país com o regresso às aulas de uma forma prática, eficaz e direta, dando apoio para enfrentar as dificuldades encontradas no funcionamento diário.  A equipa, composta por estagiários e supervisionada pela equipa de resposta ao Covid-19 da Hovione, pretende ajudar a informar os alunos dos bons hábitos a adotar e como prevenir os riscos, mas também dar apoio aos professores e funcionários para que estes tenham acesso a informação fidedigna, atualizada e simples. Aqui pode encontrar toda a nossa informação em formato PDF para poder utilizar em forma de posters na escola. Posters 01. Uso de Máscara A / Uso de Máscara 02. Uso de Máscara B  03. Retirar a Máscara 04. Regras para sair de casa 05. Recomendações 06. Proteção Covid-19 07. Lave as mãos com frequência 08. Lavagem de mãos / Lavagem de mãos 09. Lavagem de mãos com gel desinfetante 10. Como medir a temperatura 11. Medidas Gerais 12. Medidas Escolas 13. Utilização de Líxivia (1) 14. Utilização de Líxivia (2) 15. Instruções para Elevadores 16. Distanciamento Social 17. Desinfetar Superfícies   Sabe mais em ABCovid.pt Segue-nos nas redes sociais:           Esta certificação tem a validade de 6 meses e é renovada após auditorias de acompanhamento previamente agendadas ou sem aviso prévio.        Aluno de artes de 17 anos da António Arroio vence concurso ABCovid Tomás Oliveira, de 17 anos, aluno da Escola Artística António Arroio, em Lisboa, é o vencedor do concurso ABCovid, com o vídeo “Covid-19 simplificado para totós”, em que explica de modo simples e gráfico porque precisamos de máscara para nos protegermos do novo coronavírus. O concurso ABCovide é uma iniciativa dos estagiários da Hovione dirigida a estudantes do ensino básico e secundário. Para mais informações visite a página www.abcovid.pt     

News

Covid-19 / Coronavirus

Jul 15, 2022

The Sustainability Report 2019-2020 is published under the title “Elements of the future. For tomorrow and beyond, no matter what.”  This is the fourth Sustainability Report published by Hovione and is intended to demonstrate our accountability to our stakeholders by communicating the company's progress on Environmental, Social and Governance (ESG) topics. The Report also reflects our alignment to the United Nations Sustainable Development Goals (UN SDGs).  The report has been prepared in line with the Global Reporting Initiative Standards content and quality principles, to ensure information accuracy, clarity and reliability. These standards enable greater transparency and accountability of organizations, by enhancing global comparability and quality of information around ESG performance. The information covers all our owned manufacturing and research facilities worldwide and the data presented is global. As a company, we want to manufacture and deliver medicines of the highest quality to the patients aligned with our commitment to operating a sustainable business. We have as reference the highest standards of safety and environmental performance, staffed by an engaged and diverse workforce. Being “In it for life” means that we are committed to protecting our people, our communities, our partners and the environment around us.   Find more about Sustainability at Hovione  

News

Hovione releases its 4th Sustainability Report

Jul 14, 2022

In this episode of the Drug Solutions Podcast, Feliza Mirasol, science editor, discusses the changing parameters for oral solid dosage forms as driven by APIs and new chemical entities with Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione.     Oral solid dosage forms are a dynamic, ever-changing landscape, driven primarily by more highly potent new chemical entities (NCEs) that require particularly specific formulations. In this Drug Solutions Podcast episode, Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione, discuss how, in addition to NCEs, older, more established APIs are finding renewed life because these APIs are continually enhanced to have higher potency at lower doses, changing the way their formulation is handled. Looking toward the future, the bio/pharma industry is also tackling the issue of converting large-molecule (biologic) drugs into orally administered dosage, rather than parenteral administration, for increased patient compliance. Among the issues discussed are: The latest developments in oral solid dosage technology and methodologies What remains the biggest challenges in formulating APIs for oral solid dosage administration How the industry is tackling the issue of enhancing bioavailability through better oral solid dosage formulations/technologies, etc. Some “best-practice” approaches to formulating oral solid dosage products   You might be interested in: Learning more about our optimal solutions for complex drug products Making your drug soluble with Dispersome® technology    

Article

Drug Solutions Podcast: The Evolving Landscape of Oral Solid Dosage Forms

Jun 21, 2022

Lisbon, Portugal and Shanghai, China, 9 May 2022 – Hovione, the leader in spray drying and particle engineering, announced today an exclusive license agreement for a preclinical ophthalmology program, JX08, with Ji Xing Pharmaceuticals Limited (JIXING).  JIXING is a biotechnology company headquartered in Shanghai and backed by RTW Investments, LP (RTW), a leading life sciences investment firm, that is focused on advancing innovative medicines for patients with ophthalmic and cardiovascular diseases. Under the license agreement, JIXING will receive global rights to JX08 and lead the full life cycle of development from preclinical through commercialization.  “We are excited to partner with Hovione and today’s agreement further strengthens JIXING’s ophthalmology pipeline beyond its current focus on presbyopia and dry eye disease,” said Peter Fong, PhD, board executive director, JIXING. “In addition, this agreement marks a significant step for the company as it highlights its development from a China focused, late clinical-stage biotech to an innovation pioneer with full life cycle development capabilities to reach customers and patients globally.” “We are extremely pleased to enter into this partnership with JIXING and help the company build upon its existing ophthalmology pipeline while further enhancing Hovione’s leadership position in spray dried dispersions” said Marco Gil, VP Sales at Hovione adding “Our highly experienced and committed teams can support pharma and biotech companies worldwide on their path to clinical success and commercialization, offering the best scale-up science, extensive manufacturing capacity and an excellent approval track record.” This Global License Agreement is aligned with Hovione’s strategy to offer integrated product solutions for drug delivery that co-create value with its partners and enable the development of innovative medicines that maximize patient benefit.  Destum Partners acted as business development and licensing transaction advisor to Hovione.      About JIXING: JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients in China with serious and life-threatening diseases. Backed by RTW Investments, LP, JIXING was founded in 2019 and partners with global biotechnology companies to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiovascular and ophthalmic diseases. With a strong and further developing asset pipeline, seasoned management team, and patient-centric focus, JIXING is dedicated to delivering a meaningful and lasting impact on patients in Greater China. For further information about JIXING, please visit www.jixingbio.com    About Hovione: Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API, formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.    

Press Release

Hovione and JIXING Announce an Exclusive Global License Agreement for Ophthalmology Program

May 09, 2022

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