BioProcess International: Multiproduct Facility Design and Control for Biologics

Today's excerpt has been provided by Bo Chi, FDA CDER, Julia Edwards,Genentech, Jun Park, FDA CDER Stefanie Pluschkell, Pfizer , Nancy Waites, FDA CDER, Elizabeth Yamashita, Savient Pharmaceuticals, Siddharth Advant, ImClone Systems, Wassim Nashabeh,Genentech, Lorna D. McLeod, BioProcess International. 

Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans.

A Chemistry, Manufacturing, and Controls (CMC) Strategy forum was held in Bethesda, MD, in August 2011 to highlight various challenges, risks, and control strategies associated with multiproduct facilities. Multiproduct strategies for the manufacture of a variety of product types at different life-cycle stages and potentially using different host cells were presented with case studies. Experts from both industry and global health authorities discussed facility design considerations as well as procedural controls such as cleaning validation and product testing. The importance of quality risk management (QRM) to multiproduct operations and controls was also discussed using practical examples of risk-based approaches to meet the challenges of multiproduct manufacturing. Session 1: Design Considerations

What are the principal challenges in building a flexible, scalable, multiproduct manufacturing network?

The biotechnology environment is changing. Unprecedented yields are now the norm, but smaller batch sizes are needed to accommodate increasingly personalized medicines. New expression technologies such as transgenics will require different dosage forms. Rising expectations for sponsors to build quality into their manufacturing processes rather than relying on end-product testing are resulting in a changing paradigm for validation activities and life-cycle risk management. Competitive pressure from biosimilars will require keeping cost of goods as low as possible without sacrificing quality.

Decisions must be based on comprehensive global and regional business and regulatory strategies as defined by each company — sponsors and contract manufacturing organizations (CMOs). That task can be complicated by many factors, including, for example, differing regulatory interpretations in different jurisdictions. In addition, appropriate records have to be maintained. If there are multiple products and multiple jurisdictions involved, the record-keeping can become extremely complex. Manufacturing challenges arise from the difficulty of working with newer- and older-generation products in multiple regions and within multiple product categories. Manufacturers must also keep up with guidances in multiple regions for multiple products, which is not a simple and straightforward undertaking.


You can view the full article here. BPI will be joining us February 10-12 for IBC's 2nd Annual Flexible Facilities Conference taking place in February 24-25 in Berkley, CA. To learn more, view our agenda.

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