Webinar-Recorded

Webinar - Process Optimization for Monoclonal Antibody (mAb) Commercial Manufacturing

Process characterization and validation is an important step in the product development journey and late-phase development. In some cases, process optimization is required for an existing manufacturing process before process characterization begins. Catalent will share a case study of a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline. This presentation highlights the strategic plan Catalent executed to meet the needs of the program without sacrificing the thorough scientific evaluation of the process required for a successful validation campaign.

Learn more about:

Details on the optimization process for both upstream and downstream manufacturing processes.

Catalent’s workflows for process characterization of the optimized process with examples.

A case study of how to strategically decrease the timeline from process optimization to commercial manufacturing.

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Why Catalent?

Catalyst + Talent

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 17,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.

More products. Better treatments. Reliably supplied.™