Press Room

Press Release / Oct 19, 2015

Hovione acquires a Formulation Plant

Hovione announced today that it is investing in specialized formulation capabilities.

Loures, Portugal, October 19th, 2015 – Hovione announced today that it is investing in specialized formulation capabilities. The first step of the plan was the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

The facility will be engineered to enable to work with highly potent APIs and moisture sensitive compounds and will have dedicated rooms to allow for concurrent manufacture of these products. The facility will be capable to prepare a wide range of materials suitable for clinical trials as well as commercial batches meeting global regulatory requirements.

“Over the last decade we have built great knowledge in developing final dosage forms in the area of dry powder inhalation and oral dosage forms and have installed state-of-the-art formulation equipment to support these activities. Adding to our drug substance and particle engineering capabilities this new plant expands our integrated offer and technological capabilities to provide the best service to our customers”, said Filipe Gaspar, Hovione’s Vice-President R&D. “

“With this investment we will be able to expand our offerings and provide our clients with new services. I am sure our customers will value the option of not having to ship the material that comes out of our reactors and spray dryers to outside the walls of our site and away from our trusted quality culture.  This is also a great way to speed up the entire CMC development to meet the needs of the growing number of accelerated programs that our clients ask us to deliver on”, said Guy Villax, Hovione’s Chief Executive.

About Hovione

Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

 

 

Also in the Press Room

See All

Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024