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Press Clipping / Jan 17, 2022

Pharmaceutical services to grow for another year

C&EN, 17 January 2022

Solid growth and sizable investments will continue in the pharmaceutical services sector as contract manufacturers of active pharmaceutical ingredients (APIs) and drug intermediates move into a third year of navigating the unpredictable impact of the pandemic.

“Aside from what you can’t predict, it’s a very good time to be in contract services,” says Wayne Weiner, who heads the consulting firm PharmaTech Solutions. “It doesn’t seem the funding will dry up for biotechs, which are really driving a lot of the innovation.” And biotech innovators without production assets are increasingly bringing drug candidates to market themselves rather than licensing to larger drug companies, thus generating longer-term contracts with service firms, Weiner says.

But James Bruno, president of another consulting firm, Chemical and Pharmaceutical Solutions, sees a red flag. “I think we are going to be short on capacity all year,” he says. “Everybody seems to be booked.”

 

Managers at service firms agree that capacity constraint is a concern, and they point to continued investment in new capacity in response. Hovione, CordenPharma, and Pharmteco are among the companies with plans to add small-molecule API capacity.

Hovione is expanding on both sides of the Atlantic; the Portuguese firm is 2 years into a 3-year program that is expected to increase overall capacity by 25%. CordenPharma will expand clinical-scale peptide production in Frankfurt, Germany, and solid-dose drug output in Plankstadt, Germany. Pharmteco is expanding API production in South Korea and is adding capacity at a newly acquired cell and gene therapy site in France.

 

While service providers are likely to continue broadening their offerings beyond small-molecule API production in 2022, services for the emerging cell and gene therapy industry will develop on a parallel track and attract only a handful of the largest traditional firms. Cell and gene therapy is getting a lot of attention, Bruno says, but most of the investment in the drug services sector will continue to be in small-molecule production.

 

Read the article at CEN.org

 

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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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