Evaluation of the "Scale-Out" Biomanufacturing Strategy from Early Clinical Stage to Commercialization

BPI Contributor

November 3, 2017

20 Min View
Evaluation of the "Scale-Out" Biomanufacturing Strategy from Early Clinical Stage to Commercialization

Date: Nov 3, 2017

Duration: 20 Min

This webcast features: Jie Chen, MD, MS, Vice President of CMC Management, WuXi Biologics

The success of therapeutic biologics over the past decades has reshaped the pharmaceutical industry landscape. From orphan to biosimilar to novel blockbuster drugs, the production demands can range from grams to metric tons of biopharmaceutical products each year. This diverse range in manufacturing scale coupled with thousands of biologics in the development pipeline, has had significant impact on the design of biologics production models.  Without sacrificing quality, next-generation biomanufacturing facilities are emerging to meet these challenges with “value” (not “volume”) driving the design.  Thus, new facilities are now focused on multi-product and “scale-out” designs, which offer flexibility, scalability, efficiency, safety and regulatory compliance, instead of traditional single product and “scale-up” models. WuXi Biologics has constructed the world’s largest mammalian cell culture manufacturing facility using disposable bioreactors with 2 x 1,000 L perfusion and 14 x 2,000 L fed-batch capacity.  This facilities’ design will be used as the basis for the discussion in this webinar.

This webinar discusses:

  • Upstream scale-out strategy using disposable bioreactors

  • How the scale-out strategy reduces risk to product quality and process performance as product demand increases throughout development and beyond

  • Integration of this scale-out cell culture approach with continuous downstream processing

  • Thoughtful hybrid combination of disposable and stainless steel tanks to address cost concerns.

  • Process validation design to adapt to product demand over the product lifecycle.

  • Design considerations to ensure safety and regulatory compliance for a multi-product facility.

  • Scalability and flexibility to accommodate biopharmaceuticals with different productivity levels and wide-ranging market demands.

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