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Press Clipping / Sep 07, 2022

Hovione expands manufacturing with continuous manufacturing facility

Manufacturing Chemist, 7 September 2022

Continuous Tableting at Hovione | Hovione

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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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  

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