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The Portuguese CDMO has announced plans to improve production capacity by bringing in commercial scale equipment for blending, tabletting and coating. The new equipment will work alongside existing smaller scale equipment to offer customers a "one site shop" to take products through the development process to market. The contract development and manufacturing organisation (CDMO), headquartered in Loures, Portugal, began its expansion project in 2016 and stated that this will continue for the next five years. The first step of this process began with moving its development services to a 7,000 m2 facility in Lisbon, where the company handles potent and highly potent compounds. Frédéric Kahn, VP of marketing and sales at Hovione, explained, "Our customers now see drug product manufacturing at the site where they produce their drug product intermediate as a natural extension of the range of value-added services they expect from us. They want to keep their product in the same capable hands." The CDMO announced that the capacity expansion would be completed alongside the qualification of its continuous tabletting line, which it expects to be completed by the end of 2018. Hovione completed its continuous manufacturing installation at its New Jersey, US, site at the end of last year - after doubling the size of the development and manufacturing operations.   Read entire article          

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in-PharmaTechnologist, November 12, 2018

Hovione expands production capacity of oral dosage forms

Nov 12, 2018

Diane Villax poses in 1962 with her husband, Ivan (left), and this year with her son, Guy, in front of the house, Guy’s current home, where she and Ivan launched Hovione in 1959.     Diane Villax, Hovione’s still-active matriarch, recounts the rise of the pioneering firm He started, the poor chap, at the age of 23,” recalls Diane Villax of her son Guy’s debut in 1984 at Hovione, the family’s pharmaceutical chemical business. “He was thrown to the lions in the Far East. To China. He was told by his father, ‘Build me a factory in Macau. Get me some land, talk to the authorities, and build me a factory.” This he did, she says. “He built it in 14 months, ran it for six months, and asked for an FDA inspection.” Still marveling at the audacity of the project, Diane recounts the many roadblocks to building a factory in Macau, a former Portuguese colony, now a Las Vegas-like gaming resort, where no construction engineers were up to the project in 1984. Shipping construction materials, glass-lined tanks, and other apparatuses from Italy, Greece, and the company’s home base of Lisbon was another daunting challenge, given that the only suitable cargo port was in Rotterdam, the Netherlands. Her daughter, Sofia, was also deployed to China, in charge of quality control at the new plant. Diane remembers Sofia calling home rattled after an interview with an inspector who brusquely dismissed the upstart plant’s chances of passing a U.S. Food & Drug Administration audit. “Poor child,” she says. “Well, they had the inspection, and it was fine, so then they all celebrated.” Over a Saturday lunch of boiled prawns and salad on the patio of her home in a Lisbon suburb, Diane shares several other anecdotes of how she and her husband, the chemist Ivan Villax, started a company in their basement, developing fermentation processes for the manufacture of antibiotics. It has evolved over 59 years to become a major supplier of drug ingredients and associated services, with factories on three continents. Ivan died in 2003, but at 83 Diane remains active with Hovione. She is a board member, having stepped down as chair only two years ago. Guy and Sofia are also on the board, along with four outside nonexecutive directors, including the current chair. Passing the chair to an outsider, Diane says, seemed like the thing to do now that the company has achieved a critical mass.   Born in Portugal but raised in England—her mother Portuguese, her father British—Diane Du Boulay met Ivan, a Hungarian chemist displaced by the Russian invasion after World War II, in 1956. Both their families had moved to Lisbon. Ivan came from France, where he studied microbiology, developing chemistry for penicillin, tetracycline, and other antibiotics in his spare time. “I think he got his first patent in 1955,” Diane recalls. “He was enjoying life in Lisbon. A young man about town and a scientist and a bit of a magician at dinner parties. He was very much in demand.” The two married and started the company with two partners, both of whom left shortly thereafter. Diane and Ivan began by selling antibiotics and other generic drugs, achieving their first big success selling betamethasone in Japan. They built a manufacturing plant on land his family owned outside Lisbon in Loures. “Ivan was obviously the inventor, the producer, and the salesman,” she says. “Somebody had to look after the back office, issue invoices, talk to the banks, and get some money. So that was me. For 35 years, nobody signed a check except for me. I was in charge of all the imports and exports and all the licenses.” The focus remained on generics, Diane says, until Guy came back from an InformEx exposition in the U.S. in 1993, enthusiastic about exclusive synthesis of active pharmaceutical ingredients (APIs). They got a call from Bristol-Myers Squibb shortly thereafter with a request to make an API, found a chemical engineer willing to take on the complicated chemistry, and never turned back. Nor has Diane disengaged from oversight of the company’s business, which in one famous instance involved direct engagement with a chemical. Early on, with Ivan on the road, Diane was awakened one night by a chemical smell in the house. She called an engineer who worked for the company, and the two identified a leaking vessel in the basement. They found an empty container. Preparing to transfer the contents of the vessel, Diane realized that someone would have to suck on the hose to get the liquid moving. The engineer demurred, noting that they had no idea what was leaking. “I had to do it,” she says. “Somebody had to get it going.” The operation was a success, and Diane soon learned that the solvent was ethyl acetate. “My husband was rather horrified when he learned of this.” Diane Villax was awarded Portugal’s Scientific Merit Medal at the opening of Science 2017, a science and technology meeting in Lisbon. The medal is given in recognition of contributions to the development of science and scientific culture in Portugal.   Read the article at C&EN online   Discover our 60+ years of history  

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C&EN, November 12, 2018

How Hovione grew from a basement lab to a global pharmaceutical services company

Nov 12, 2018

A pharmaceutical services pioneer cues up continuous tableting as it doubles manufacturing. Guy Villax, CEO of Hovione, stands in the central hall of the company’s new R&D center in Lisbon. On the wall beside him is a mural with photographs commemorating the family-owned pharmaceutical chemistry firm’s milestones since it was founded by his parents, Ivan and Diane Villax, 59 years ago. There is also a nearly floor-to-ceiling portrait of Steve Jobs, the cofounder of Apple. Guy Villax is fond of extolling innovation and inspirational figures such as Jobs and Charles Darwin, who on another mural is quoted regarding species’ responsiveness to change. That mural also nods to an evolution in how Hovione regards the scientists who work in R&D. His father, he explains, was a man of his times. “He didn’t give much space to empowerment and all that,” he says. Villax, on the other hand, has been giving employee empowerment a lot of space recently.   The 7,000-m2 R&D center was designed with low-walled cubicles and picture windows looking into labs and conference rooms. A large tote board on the second floor lists the company’s patents, with a good number of entries—failed applications—crossed out with red lines. Banners from the ceiling celebrate the launch of new drugs for which Hovione supplied active pharmaceutical ingredients (APIs) and other services. There were four in 2017, close to 10% of the 46 drugs approved by the U.S. Food & Drug Administration. Villax says he wants to get chemists to look up from the bench at the big picture. “It feels a little less inhuman, not doing the Charlie Chaplin things,” he says, referring to Chaplin’s skewering of the machine age in the film “Modern Times.” “If you give people a sense of what it’s all about and how they contribute, they fill in their batch records with greater care. But to keep people excited about doing new things, you have to give them the right tools.” R&D at headquarters is one thing. Manufacturing on three continents is another, for a family-owned firm with plans to double capacity at most of its sites. But Villax sees a continuum from the lab to the plant in which developments in both realms are guided by innovative science and customer demand. It’s a philosophy that has kept Hovione afloat as many other firms in the drug service industry get swallowed up by financial buyers or big corporations. Indeed, Hovione has been adding tools beyond the lab, including at its plant in nearby Loures, where it is doubling manufacturing capacity and starting up a finished-dosage drug plant it acquired in 2015 and then retooled. Meanwhile, the company is adding a second pilot plant at its smaller-scale facility in East Windsor, N.J., and commissioning the second of two manufacturing buildings at a large-scale facility in Cork, Ireland, capacity that has been mothballed since Hovione bought the site from Pfizer in 2009. The company has also added a wholly new tool in New Jersey—a continuous tableting plant­—for which it has a contract to work with Vertex Pharmaceuticals. Hovione will offer the service for other customers there and in Lisbon, where a similar plant is scheduled to be installed. Hovione invested about $100 million in 2017 and plans to spend as much again this year and next. The plan over the next three years is to continue investing, especially in Portugal, where the firm will add 165 m3 of chemical synthesis capacity, a spray-dryer building, and a 1,200-m2 analytical lab. Hovione’s capacity expansion is ambitious but somewhat conventional for a firm whose major investments have historically startled industry watchers. In 1985, for example, Hovione built a plant in Macau, the first instance of a European drug service company investing in China. In 2002, it opened the New Jersey plant, starting a trend of European firms establishing small-scale beachheads in the U.S. Then came the Cork acquisition, which, in addition to bulking up manufacturing capacity with a plant Pfizer no longer needed, brought a huge spray-drying facility. Hovione pioneered and remains a leader among firms offering this now-popular service. If anything, the move into tableting is a bit of catch-up for Villax, who not long ago spoke skeptically of peers adding final-dosage service to chemistry. The merger of DSM’s pharmaceutical chemical business with Patheon’s finished-drug service was a seeming vindication of this one-stop-shop approach. Several other firms, including Siegfried, Carbogen Amcis, and Aesica, also invested in dosage-form manufacturing, as Hovione held fast with chemistry alone. Villax finally blinked in 2015, purchasing a plant literally over the fence from Hovione’s main site in Loures. Villax insists he would never have added dosage services if the plant weren’t adjacent to API manufacturing. He says the company now has two customers for which it does particle engineering, API synthesis, and final product manufacturing at the one site.   He emphasizes that Hovione had signed up Vertex for continuous tableting before committing to the cutting-edge technology in New Jersey. Dosage-form service “is not a leap or change in direction,” he insists. “Who do you think showed us the way? The clients.” In New Jersey, site general manager Filipe Tomás is focused on increasing capacity for clients in the early stages of drug development. “This site cannot be at maximum capacity,” he says. “We expect to be at 60% to 70% occupancy and always be a door to customers when they have a lead.” And that door is about to open on continuous tableting, which is beginning registration runs and is set to go into commercial production next year. Hovione’s hope that the service will be of interest is borne out several miles away at the Rutgers University Engineering Research Center for Structured Organic Particulate Systems. There, engineers have worked with Vertex and Janssen Pharmaceuticals, firms that Douglas Hausner, associate director of industrial liaison at the center, describes as early adopters. Hovione hired several students and engineers from the center as it secured the contract with Vertex. Tomás sees the addition of tableting as a natural progression in pharmaceutical services rather than a break from Hovione’s chemistry tradition. The new apparatus, a three-story rig with a belt of tablet troughs running from top to bottom, is utterly unlike the pilot reactors elsewhere in the facility. “This is a technology that we think adds value,” specifically that of speed to market, Tomás says. He points to a newly constructed space near the tableting machinery in which the company may add blister packaging, a service Vertex is not currently signed on for. The site has also doubled its research space with the creation of an open environment that mirrors the new Lisbon center. Along with a significant increase in staff, the New Jersey labs have increased technical firepower in areas such as particle design and engineering. Back in Lisbon, Cláudia Ferreira, general manager of R&D services, says research and technology have seen many changes in recent years but have still followed one basic course. “Hovione always takes advantage of its core way of working, which is science driven and innovation driven. That hasn’t changed.” Rafael Antunes, senior director of R&D, adds that remaining a family-owned company allows Hovione to take risks and make long-term investments, including in its research endeavors. “We like to be challenged,” he says. “We feel we have to differentiate ourselves from the competition, to set the bar high on the technologies we adopt, and to have the right people.”   Hovione employs about 90 Ph.D. scientists. Under a program launched five years ago, 11 Ph.D. students are doing research at the firm. The four who have completed their program have been hired by the company. “What you have in our industry, as in so many others, is an expansion of knowledge and technology,” Villax says. “You have to keep up, and you have to solve problems faster.” James Bruno, president of the consulting firm Chemical & Pharmaceutical Solutions, says that Villax makes some risky moves but that they tend to pay off, with the latest venture in continuous tableting appearing to be another good one. “Sometimes I’ve scratched my head and said, ‘What is he thinking?’ ” Bruno says. “But five years later, you got to go back and say, ‘Well, you know, that was a pretty good idea.’ I think Guy always has a tendency to be a step ahead of everybody else in general. He’s doing things that people are thinking about doing.” Villax says he’s often challenged on the question of whether, despite a good run, a major disruption in pharmaceutical technology might “get Hovione bankrupt.” This, he admits, is a good question. But he also points to an uninterrupted line in pharmacology development that has yet to be disrupted by genomics, digital technologies, and other game-changing leaps in science. “I think the pharmacy is something relatively unchanged for 30,000 or 40,000 years. Even when you had hunters and gatherers, I’m sure there were some people who knew what certain plants did for you. So I can’t see what is really going to disrupt us,” he says, smiling. “Famous last words!”   Read the article at C&EN online  

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C&EN, November 12, 2018

Hovione bulks up, with a twist

Nov 12, 2018

Although the majority of new drug candidates suffer from poor solubility and bioavailability, oral solid dosage forms remain the preferred route of administration due to their ease of use and convenience for patients and caregivers. In recent years, numerous drugs formulated as amorphous solid dispersions (ASDs) have been successfully commercialized, confirming the effectiveness of these technologies for enhancing the dissolution of challenging APIs. Read the full article   Topics covered in the article: Focus on Spray Drying Addressing Solubility Issues Benefits of ASDs Two Leading ASD Technologies Maintaining the Metastable Form Dealing with Brick Dust Facilitating ASD Development and Manufacturing Greater Understanding for Rational Design   Read the full article    

Article
Pharma's Almanac, 26 October, 2018

The Coming of Age of Amorphous Solid Dispersions

Oct 26, 2018

During October 15th to 17th, Hovione New Jersey hosted the Pharmaceutical Process Analytics Roundtable (PPAR) annual event. PPAR is a meeting/gathering of PAT practioneers in the Pharma industry that happens once a year where several PAT related topics are discussed (e.g.: regulatory aspects, technology novelties, people & organization, etc.). Continuous Manufacturing have become a major topic as it makes intense use of PAT for process control and release of product. Participants for this year event came from Pfizer, Merck, Janssen, BMS, Eli Lilly, AbbVie, Biogen, Amgen, GSK, Sanofi, Vertex, and Genentech. Nuno Matos and Savitha Panikar were the Hovione participants.

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The Pharmaceutical Process Analytics Roundtable (PPAR) Annual Event at Hovione New Jersey

Hovione New Jersey hosts 2018 PPAR Conference

Oct 23, 2018

Loures, Portugal, October 17, 2018 – Hovione announces plan to increase production capacity in oral dosage forms in Portugal, to strengthen the integrated offering. New commercial scale equipment for blending, tableting and coating will complement existing development small scale equipment. This decision to expand follows growing customer demand since, one year ago Hovione started offering end-to-end solutions, from drug substance to drug product, from the Loures site. As a specialist integrated CDMO, Hovione is increasingly being chosen as a solution partner from Drug Substance to Drug Product. Hovione ‘One Site Shop’ allows customers to streamline their supply chain, reduce time to market and benefit from seamless project management. This increase in capacity will help Hovione customers to consistently bring products faster to market. “Hovione has a unique value proposition when it comes to processing amorphous solid dispersions. Our Company has more than 15 years of experience in pharmaceutical spray drying and has produced hundreds of batches for clinical trials and commercial supplies.  Our customers now see drug product manufacturing at the site where they produce their drug product intermediate as a natural extension of the range of value added services they expect from us. They want to keep their product in the same capable hands. This investment shows our commitment to listen to our customers and continue to support their evolving needs,” says Frédéric Kahn Vice-President of Marketing & Sales at Hovione. In parallel Hovione will be completing by the end of 2018, the qualification of its continuous tableting line at Hovione New Jersey, which will enable the site to offer end-to-end solutions for US customers that are keen to keep their supply chain local. The capacity expansion program started in 2016 and will continue in the coming five years. In the first two years, Hovione has relocated its development services to a new centre with 7.000 m2 in Lisbon, fully equipped with the most recent tools where Hovione is able to handle potent and highly potent compounds. Globally within our R&D we added new labs, new drug product centres, pilot plants and our state-of-the-art particle engineering technologies both in the US and in PT. Locally, the Loures site expanded its drug substance reaction vessel capacity with a small-scale production area and a new pilot plant. We also installed more spray drying capacity at the site and started the operation of a new drug product centre equipped with oral dosage form and inhalation manufacturing capabilities. In New Jersey, Hovione doubled the size of its development and manufacturing operations. In Cork we also expanded our chemical synthesis capacity devoted to contract manufacturing. Overall, Hovione’s steadfast growth is the result of an integrated synergy that allows the company to serve both the global markets and also to respond to specific customers’ demands whenever necessary. At Hovione, we want to be the CDMO that customers like the most, therefore we put the customers’ needs at the centre of everything we do relying on three growth pillars: operational excellence, customer centricity and the team members’ engagement.   About Hovione Hovione has almost 60 years of experience as a Specialist Integrated CDMO offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services.    

Press Release
‘One Site Shop’ expands to respond to growing demands

Hovione increases production capacity

Oct 17, 2018

Integration of new modeling and analytical tools with flow chemistry are notable trends A key focus of the pharmaceutical industry today is increasing efficiency and productivity to reduce cost and time to market. These issues are being addressed across the entire development lifecycle, including in API development labs. From improvement of existing technologies to the introduction of more advanced analytical instruments and modeling software, development labs are focused on increasing speed of optimization and reducing issues during scale up. Need for speed Innovation in API development labs is taking place at all pharmaceutical companies. Adam Kujath, senior director of global manufacturing sciences and technology at Alcami, points out how this innovation is being driven largely by smaller pharma and biotech companies. “Speed is the most important thing for these organizations as they work to get into and through the clinic as quickly as possible. Therefore, most investments are not necessarily for exotic new technologies, but rather expansion and improvement of those that drive more efficient throughput,” he comments. Examples include robotic screening equipment, parallel reactors, and more advanced in-line analytics to support process characterization. Flow chemistry for the synthesis of APIs is an important trend in the industry, according to Rui Loureiro, director of R&D process chemistry development for Hovione. “Flow chemistry enables the implementation of chemistries that previously were not possible due to a lack of technology. As a result, chemists are gaining access to new methods for producing new and more complex molecules,” he says. It can also dramatically reduce scale-up times because the same equipment can be used in the lab and for production, just for longer periods of time and/or in multiple copies. A side benefit of the interest in flow chemistry is improvements in process analytical technology (PAT)—including nuclear magnetic resonance (NMR) spectroscopy and high-performance liquid chromatography (HPLC)—are being developed to allow their use for continuous manufacturing, according to Loureiro. Equipment integration and miniaturization Not only advances in equipment technology, but the ability to integrate different aspects of API development laboratory initiatives is helping to speed up activities. Access to a growing selection of miniaturized probes with high resolutions allows researchers to more quickly gain a better understanding of how crystals are formed and how polymorphic forms can be controlled, according to Jerod Robertson, a senior process chemist at Hovione. He points to smaller probes for focused- beam reflectance measurements and particle vision and measurement from Mettler Toledo as examples that allow performance of crystallization studies in smaller reactors using smaller quantities of expensive API. “Using less material is important since at the beginning of development there normally aren’t significant amounts of product available, but the shape and size of the obtained crystals should be understood as in-depth as possible because these parameters can significantly impact process development down the road to reaching the commercial phase,” Robertson explains. Most notable for Alcami when it comes to equipment advances has been the integration of multiple systems, according to Kujath. “When a piece of equipment capable of performing automated, high-throughput synthesis or crystallization experiments is directly integrated with direct sampling for multiple forms of analysis on the same system, it drives efficiency, such as the Bruker D8 Discover HTS2. Better, more robust data sets can be obtained, making tools such as design of experiments more accessible for earlier development activities and thereby allowing Alcami to create stronger early clinical processes,” he observes. More intuitive software Advances in software are equally important as improved equipment and technology. “Software packages are becoming more intuitive, which is important as the databases behind them grow,” Kujath notes. “Scientists today build on the developments of those who came before them, and the software packages that exist today are making that information more accessible for application on a daily basis,” he adds. At Hovione, using the simple but effective Dynochem (Scale-Up Systems) and Visimix (VisiMix Ltd.) software packages for optimizing scale up and mixing processes and equipment have been great tools for chemists responsible for the scale-up of API syntheses. “The use of Dynochem has enabled Hovione to achieve faster development of unit operations such as solvent swapping, and it has also been a great tool for understanding reaction mechanisms, including those that lead to impurity formation,” Loureiro says. Such understanding helps the development chemists implement effective control strategies that ensure product quality. The use of tools such as Visimix provides chemists with a greater understanding of effects like mass transfer and mixing and how they can impact product quality, according to Robertson. This information can be used to gain insight into how reactions will run at scale or when they are changed from one piece of equipment to another. Hovione is also leveraging software designed for ab initio calculations, such as Gaussian calculations. “These types of software are very important because they provide chemists with a better understanding of the possible transition states that can be formed during the different steps in an API synthesis route. This information is helpful for identification of pathways that lead to impurity formation,” says Loureiro. Better modeling for greater control The software packages used at Hovione mainly help with modeling. The information that is obtained on process kinetics and impurity formation is used to determine the optimum control strategies, according to Robertson. The company also uses software such as SuperPro Designer (Intelligen) for batch process simulations and computational fluid dynamics software for modeling the scale up of processes when moving from the lab to large-scale production. The algorithms used in modeling tools are becoming more accurate and predictive in part because the data behind them continue to grow, according to Kujath. Alcami has seen that they are as a result useful for further refining processes. Better modeling for greater control The software packages used at Hovione mainly help with modeling. The information that is obtained on process kinetics and impurity formation is used to determine the optimum control strategies, according to Robertson. The company also uses software such as SuperPro Designer (Intelligen) for batch process simulations and computational fluid dynamics software for modeling the scale up of processes when moving from the lab to large-scale production. The algorithms used in modeling tools are becoming more accurate and predictive in part because the data behind them continue to grow, according to Kujath. Alcami has seen that they are as a result useful for further refining processes.   C. Challener, “Efficiency Demands Drive Advances in API Labs,” Pharmaceutical Technology 42 (10) 2018.   Read the article on Pharmaceutical Technology website

Article
Pharmaceutical Technology, October 2, 2018

Efficiency Demands Drive Advances in API Labs

Oct 02, 2018

On September 26th, 2018, Hovione New Jersey held the Opening Ceremony of the site expansion. This expansion is the result of an investment over €30 million in its R&D Center. The Mayor of East Windsor, New Jersey, Janice S. Mironov, the Hovione CEO, Guy Villax and the AICEP Commissioner in the USA, Manuel Couto Miranda were present. The new R&D center represents an expansion of the range of Hovione's service offering in the US market and includes state-of-the-art technologies in the particle engineering and continuous manufacturing areas.   Learn More: Hovione reports on recent capacity expansion and future plans to support growth Hovione New Jersey  

News
Hovione invests over €30m in the USA

Hovione New Jersey Site Expansion - Opening Ceremony

Sep 26, 2018

Hovione New Jersey welcomes a Team from OPQ of the FDA as part of the Experiential Learning Site Visit Program for a Training on Continuous Manufacturing. The main objective was to understand the technology and the science behind it, how does industry apply it and which challenges industry faces. The main purpose was to provide the FDA team a better understanding of drug development and manufacturing processes with continuous manufacturing.      

News
Hovione New Jersey welcomes a Team from the FDA for a Training on Continuous Manufacturing

FDA OPQ Training at Hovione New Jersey Site

Sep 18, 2018

In general, how has the efficiency and productivity of pharmaceuticals increased/evolved over the last 20 years and how much of this evolution is due the knowledge and experience contract development and manufacturing companies bring to the industry? The technological evolution in manufacturing of pharmaceuticals has not evolved as rapidly as in other industries. Therefore, gains in efficiency and productivity have improved less than in those industries which needed to change. Contract and development and manufacturing companies have brought a higher productivity and more efficiency to the pharmaceutical industry through higher and better utilization of assets and leveraging the knowledge and experience gathered by working in many different products. These companies contributed significantly to the industry during the last 20 years as their business model focused intensely on increasing productivity and efficiency. Over this same time period what has been Hovione’s mission? How has the company helped the pharmaceutical industry bring safe and effective treatments to market over the last 20 years? Hovione’s mission was the contract development and manufacturing company that not only provides the benefits of an organization focused on development and manufacturing mentioned above but mostly an organization that brings innovation to the industry helping solve most complicated issues in development and manufacturing of medicines. For example, Hovione started many years ago devoting a significant effort in the understanding of particle engineering, how this could solve formulation challenges and what technologies could enable those engineered particles. Focusing on the inhalation and oral formulation of poorly soluble drugs through amorphous solid dispersions Hovione developed a wealth of knowledge and capabilities that have helped numerous companies developing new medicines that today help millions of patients worldwide that otherwise would not have been possible. Hovione today leads the development and manufacturing of amorphous solid dispersions by spray drying and has developed a wide range of new technologies like spray congealing and a combination of technologies that control particle size distribution, morphology, provide taste masking and controlled release properties that are of paramount importance for today’s pharmaceutical development and manufacturing. Specifically, what services and expertise does Hovione currently offer to assist pharmaceutical clients to bring new drugs to market? Can you talk about your Integrated Science offering, capacity expansion, and your continuous manufacturing technologies? Hovione constantly seeks new technologies, develops scientific knowledge and sees how we evolve our organization to solve issues for the pharmaceutical industry. Hovione today offers a comprehensive range of services from API to final drug product that include process development, clinical batch and commercial manufacturing involving experts in chemistry, process engineering, analytical sciences, particle engineering and formulation scientists. The development of a new medicine involves a wide range of expertise and technologies that Hovione has brought together ultimately (spray drying, microfluidization, spray congealing, co-precipitation) to provide better drugs and faster development so patients in need can have access to life changing medicines quicker. Hovione offers an integrated approach from API to drug product as mentioned above. This integration not only speeds up product development but also allows our organization, scientists and engineers to share product/process knowledge. Our strategy has been also to develop this integrated approach at the same location to facilitate all the complex process associated with developing a drug and outsourcing.  Therefore, Hovione started an investment program to add capacity at multiple locations (Europe and US) in API, spray drying and drug product formulation namely in tableting. Hovione believes that continuous manufacturing (in chemistry and drug product) brings a new way of developing and manufacturing medicines adding more quality and flexibility into the manufacture of medicines while allowing a faster development path by reducing the effort necessary in scaling up processes. Hovione has embraced these technologies and has invested in continuous tableting because we believe that this will be a transformational technology to the industry. Looking ahead, are there any drug development and manufacturing technologies being developed now that will help pharma companies bring innovative products to the market? How will Hovione meet this challenge for its current and future clients? Continuous processing is still a relatively new technology in the pharmaceutical industry. Its adoption will certainly help pharma companies to bring innovative products to the market faster. Hovione is very much interested in providing this option to pharma companies and having a contract manufacturing organization capable of providing this solution is of paramount importance for biotech companies and for the overall drug development industry. There are other technologies being developed to address the challenge of poorly soluble drugs and other particle engineering manipulation solutions that Hovione is evaluating with the goal to bring these technologies to market to provide companies with options and better results. Being an innovative company with a strong pool of scientists Hovione is very well prepared to take some of these technologies into an industrial reality and providing a real solution to develop innovative products.   Read the article at APR's website.    

Article
American Pharmaceutical Review, September 2018

An Interview with Marco Gil, PhD

Sep 01, 2018

Hovione has earned a place on the 2018 Best for the World list by scoring in the top 10 percent among all B Corps on the B Impact Assessment. Best for the World lists are segmented by: Best Overall Best for Workers Best for Communities Best for the Environment Best for Customers Best for Governance This year Hovione is on the CUSTOMERS Best For The World list. Described by B Lab as "Improving Customers’ Lives and Opportunities Through Business". What is Best for the World?  Every year, B Lab highlights the Certified B Corporations with B Impact Assessment scores in the top 10% of the entire global community. Separate lists honor companies with the best overall scores as well as scores for each individual category in the BIA.    Find more about Hovione being a B Corp      

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This year Hovione is on the CUSTOMERS Best For The World list.

Hovione is a Best For The World Company!

Jun 18, 2018

Rick Mullin interviews Frédéric Kahn at CPhI North America.         Hovione, which has likewise added services, including spray drying and finished-dose form manufacturing, in the past two years, continues to invest both at its headquarters in Loures, Portugal, and at its technology center in East Windsor, N.J. The company spent about $100 million in 2017 and plans to invest as much again this year and next, according to Vice President for Sales and Marketing Frédéric Kahn. Hovione opened a 7,000-m2 development services center at its main manufacturing facility in Loures, equipped to handle highly potent compounds. With 200 people hired over the past three years, the site now employs a staff of 1,600. Hovione may hire another 200, Kahn said. In New Jersey, the company is in the process of doubling chemistry and analytical service capacity and will begin operating a continuous tableting facility this month. Kahn says Hovione is interested in offering one-site shopping in Portugal and New Jersey. The plan over the next three years is to continue investment, especially in Portugal, Kahn said, where the firm will add 165 m3 of chemical synthesis capacity, a spray-dryer building, and a 1,200-m3 analytical lab. “This is capacity that we are going to have to sell,” Kahn acknowledged, “but we pursued it by listening to our customers—by understanding what their requirements are in terms of API, formulation, solubility enhancements, and continuous tableting.” Kahn declined to call the added services a push toward the one-stop-shop model. Rather, he said, the firm will now offer one-site, full-supply-chain service in both Portugal and New Jersey.   Read the entire article    

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C&EN, May 21, 2018

The good times keep rolling in pharmaceutical chemicals

May 29, 2018

Small gestures can truly change the world!   Ivan Villax, who was born on April, the 16th of 1925 in a small town in Hungary, left his country when he was 23 years old with a toothbrush in one pocket and a Chemical Engineering Diploma in the other. Later on, in 1959, already in Portugal, Ivan Villax, together with Diane Villax and two other Hungarians, founded Hovione. On April the 20th of 2018 we celebrated the second Ivan Villax Day across all Hovione sites (Portugal, Ireland, Macau and USA). Team-members across all sites went back to the community and ensured that they had a significant positive impact: Planted trees in Loures Did volunteering work with homeless in Cork Donated rice and oil in Macao Donated personal care items in New Jersey Loures In Loures, about 115 Team Members from the various sites and offices of Hovione participated in an action to replant 500 trees, pines and cork oaks on a municipal site. The planting of these trees will contribute to the reduction of the CO2 emissions to the atmosphere, thus reducing the effects of climate change caused by the accumulation of greenhouse gases. This initiative was supported and closely monitored by the field technicians of the Division of Green Zones and Forests of the Municipality of Loures. Cork In Cork around 120 Team Members volunteered at two homeless shelters, in which they painted and treated the gardens of the shelters. Furthermore, the result of a Cake Sale was also donated. This year, the focus was to work with a well recognised local and national agency, the Simon Community, to support the homeless people. Macau “Love Food Sharing" was a campaign organized by Hovione Macau with the cooperation of Centro do Serviço de Fornecimento Temporário de Alimentos da Caritas and its aim is to share food and love with the elderly. On this day, 31 Team Members in Macau visited 40 elderly families in need and gave them 80 bottles of cooking oil and rice sacks. New Jersey In New Jersey, over the course of a month, 110 people donated hundreds of personal care items for local community members in need. Additionally, Team Members attended an event where they put all the items together in care packages, which included inspirational words of encouragement and support to those struggling in the local community.

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Team-members across all sites went back to the community and ensured that they had a significant positive impact

2018 Ivan Villax Day

Apr 20, 2018

        PH: How is business right now? Gil: Business is going well. The CDMO industry is quite busy, not just Hovione. It comes naturally from the good environment that investors found in the biotech sector overall, so there are many programmes ongoing in development. Business is well funded, there is a lot of activity and CDMOs benefit from that. Also, large pharma continues to divest manufacturing assets. The trends of recent years remain and I think they will continue for the next months. The off-patents business is growing too. There is a lot of interest in niche, specialised APIs with specific properties from a physical standpoint. PH: What specialised technologies are you investing in? Gil: Spray drying is one of our core technologies,...   Read the full interview

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