Process Development: Getting from Phase I to III

Successful biopharmaceutical Chemistry, Manufacturing and Controls (CMC) development requires a clear understanding of the requirements and expectations to support taking a product into the clinic. Even after the product has entered the clinic the CMC development journey continues.

In moving through the CMC development cycle, it is important to prospectively identify where there may be knowledge gaps and to create studies to address them. As process development lives in the world of imperfect knowledge, risk management is used to build robustness and contingencies into the process development plan. In trying to balance the many different factors in process development it is also essential to look at where compromises and trade-offs are in the process development approach. This webinar will identify typical points in process development where these compromises may arise.

Register for this webinar to hear a discussion about how to structure a biopharmaceutical process development program to build supporting data as the product progresses in the clinic. It will touch upon gaining understanding of the key quality attributes and critical process parameters as part of developing the process. The methodology covered will be one that takes a holistic approach to process development where, in addition to developing the processes, consideration is given to analytical method development to assess the product’s identity, strength, quality and purity; the impact of raw materials on development; and the role of robust formulation development. The discussion will also cover the importance of generating product and process intermediate stability data as part of the CMC package.

Additionally, the discussion will touch upon how developing process robustness while also managing resources is a key success factor. To explore this concept further, there will be an overview of how to define the “good enough” areas in process development, where 80% may be good enough and where it may not. It will also include where and when it makes sense to leverage platform data in process development. The discussion will also address strategies to get to a ‘fit for purpose’ process as the product progresses in the clinic.

Speaker

Louise Duffy, Ph.D., SVP, Scientific Project Leaders, Abzena

Louise has a very extensive background in the global biopharmaceutical industry with more than 30 years of experience in R&D and Commercial Supply, having held senior roles in GlaxoSmithKline as VP & Global Supply Chain Head, Biopharmaceuticals, where she also served as VP and Corporate Officer of Human Genome Sciences, Inc., and Janssen R&D (J&J) as VP & Global Head, Strategic Sciences. She has wide-ranging experience in developing, licensing and supplying biopharmaceuticals, vaccines, cell and gene therapy products for global markets. Louise has broad CMC and Regulatory experience, including the development of strategic CMC plans to support regulatory filings such as INDs, IMPDs, BLA and MAAs.

Louise holds a Ph.D. and a M.Sc. in Chemical Engineering from Imperial College, London, UK and a BSc (Comb Hons) in Chemistry and Biochemistry from the University of British Columbia, Vancouver, Canada.

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