To Be Continued...
Hovione’s New Jersey-based site has provided process development and small volume API manufacturing since 2002. In the years since its inception, the site has expanded its portfolio to include particle engineering capabilities and the handling of highly potent compounds. And in 2017, the company introduced continuous drug product manufacturing to its roster. Here, we speak with experts at Hovione, including Alexandra Adao (Head of Quality Assurance Continuous Manufacturing), Jose Santos (Head of Drug Product Continuous Manufacturing), Nuno Matos (Head of Quality Systems Management), and Sarang Oka (Process Development Engineer), about the promises and pitfalls of continuous manufacturing and how the facility is faring since it became operational.
This article was published in our sister publication, The Small Molecule Manufacturer, which celebrates the field of small molecule drug development and manufacturing with interviews and articles focusing on success stories, equipment, and new processing techniques.
Why is continuous manufacturing such an important strategy for drug manufacturers?
For years, the industry has struggled to shorten drug development cycles but many have found themselves limited by the capabilities of batch operations. Requiring less space and resources, continuous manufacturing offers companies the opportunity to manufacture drugs in one facility with a single rig. A major advantage of continuous is that rigs can run for longer when larger batches are needed without the need for scale-up. This could lead to potential savings in API over the course of the entire development cycle (although the API requirement in the early stages of development may be higher). The ability to run development in the same site also means that there is no need to transfer analytical methods and it cuts out the back and forth that often comes when such services are outsourced to other companies.
Big pharma companies are leading the way in proving that the equipment required for continuous operations can also help in lowering footprint. Pfizer’s PCMM (portable, continuous, miniature and modular) platform and GEA’s CDC50 are also strong examples of the portability of continuous manufacturing equipment and its ability to be used in train with minimum modifications to manufacture using dry compression, dry granulation or wet granulation. PCMM and CDC50 have also been used to alternate between tableting and capsule filling.
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