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.
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.Message Presenter
Who Should Attend?
- Start-up biotech companies developing biopharmaceuticals
- Biotech or pharmaceutical companies planning contract manufacturing operations of biopharmaceutical clinical trial materials for the first time or seeking to improve their tech transfer practices
What You Will Learn
The following will be discussed:
- The essential elements of a process development program to support developing a robust process in line with the product progression in the clinic
- How to take a holistic approach to developing processes with an eye to future development
- How to manage risk, make compromises and trade-offs to expedite your process development program
- How to develop robust processes while managing resources in the process development
Abzena is a leading contract provider of integrated discovery, development and manufacturing services for biologics and antibody drug conjugates (ADCs). Abzena provides the most complete set of solutions in integrated early discovery to mid-phase biotherapeutic and bioconjugation drug development and manufacturing in the biopharmaceutical industry. The company maintains resources around the world, with facilities in the US and UK. Abzena is owned by Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors. For more information, please see www.abzena.com.