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Press Clipping / Jan 04, 2023

Hovione and GEA aim to increase adoption of continuous tableting

Outsourcing-Pharma, 4 January 2023

 

The two companies, who had previously established a customer-supplier relationship, have created an agreement to advance the technology and to encourage adoption.

Hovione and GEA will work together on continuous tableting technology, pairing the former's development and manufacturing expertise with the latter's engineering capabilities.

In terms of their respective capacities, Hovione is a contract development and manufacturing organization (CDMO) providing services for drug substance and drug product. GEA is a supplier for systems and components for the pharmaceutical industry, as well as the food and beverage industry.

The aim of the partnership is to accelerate the adoption of continuous tableting technology, and also to contribute to the establishment of new standards and market acceptance of the technology, the two companies stated.

In looking to promote continuous processes, the companies outlined that such systems allow for leaner and risk-reduced development paths, streamlined supply chains, increased built-in quality, and that the manufacturing processes themselves have greater flexibility and reduced complexity.

Both companies have been working in the continuous manufacturing space for a number of years. Nearly a decade ago, GEA began working with the US Food and Drug Administration (FDA) to validate continuous manufacturing, with the company stating at the time that the arrangement marked the "start of the end of batch manufacturing".

For Hovione, the company stated that it has been actively working on developing continuous tableting solutions for the last seven years, and it recently invested in the technology within its own manufacturing network.

In September 2022, Hovione announced that it had opened a new continuous manufacturing line at its Loures site, in Portugal. At the same time as the new line, the company established a multi-disciplinary global team specialized in continuous tableting.

On its latest move in the continuous tableting space, Hovione's CEO, Jean-Luc Herbeaux, stated, "Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all... This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of continuous tableting equipment solutions and bring continuous tableting to the next levels of reliability, flexibility and adoption".

In a recent interview with Outsourcing-Pharma, Bikash Chatterjee, CEO of Pharmatech Associates, stated that there is a growing momentum behind the switch to continuous manufacturing, even though this has been spoken of for a number of years.

Chatterjee noted that one aspect that could accelerate this shift is the national policy in the US to increase the manufacturing of certain pharmaceuticals on home soil. As a result, more efficient manufacturing, such as continuous, will be required to make the process commercially viable.

 

Read the entire article at Outsourcing-Pharma.com

 

 

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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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