Webinar

Abstract:

Speed is one of the major factors to ensure success throughout the CMC development and manufacturing of biological products whether moving from gene synthesis to IND submission, or through late-stage development towards a BLA filing. The acceleration of preclinical activities into first-in-human clinical trials has never been as important as it is now, in a post-COVID-19 era, for companies to beat their competition and meet market demands.

Biologics development efforts during the COVID-19 pandemic propelled neutralizing COVID-19 monoclonal antibodies (mAbs) into the clinic at an unprecedented speed, while demonstrating and maintaining product quality and consistency. Innovative acceleration strategies used during the development of these COVID-19 programs can now be broadly considered and holistically applied to biologics development across all disease areas to further shorten CMC timelines. Notably, during the pandemic, WuXi Biologics shortened the traditional 12–18-month biologics development timeline from DNA to IND to a remarkable 3-6 months, and also enabled a neutralization mAb to go from DNA to Emergency Use Authorization (EUA) in just 14 months. To date, WuXi Biologics has supported over 40 COVID-19 projects, including 6 approved products (globally) for commercial use.

Based on the vast experience derived from the aforementioned COVID-19 programs in addition to enabling over 480 IND approvals and 30 successful BLA/MAA or EUAs across multiple countries, Dr Sherry Gu will share the collective insights and perspectives from WuXi Biologics for how companies can accelerate CMC development timelines. This webinar will review the strategies and innovative technologies spanning cell line development, analytical and biosafety testing, process development and clinical manufacturing, including key regulatory considerations. These insights demonstrate the ability to expedite timelines, as made possible by WuXi Biologics, that ensure success for clients.

Key Learning Objectives:

• Strategies for expediting biologics into the clinic from initiation of cell line development to IND filing.
• Recommendations to accelerate development, and lessons learned from COVID-19 programs that can be holistically applied in standard programs to maintain product quality and regulatory acceptance.
• Innovative technologies and platforms that support and enable the acceleration of CMC development timelines.

Speakers:

Sherry Gu, Ph.D., Executive Vice President and Chief Technology Office, WuXi Biologics

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