Ask the Expert – Implementation of Continuous Manufacturing Strategies for Protein Therapeutics

By on January 15, 2018
Ask the Expert

There continues to be growing interest in continuous processing of biological therapeutics with the primary driver being reduction of drug costs through more efficient manufacturing processes.  Together, drug developers, contract manufacturing organizations and process equipment suppliers continue to make significant advancements towards the goal of making continuous biologics manufacturing a reality from the initiation of cell culture to the production of bulk drug substance.  Compared to traditional batch technologies, continuous bioprocessing can offer more flexibility and in some cases improve product quality in addition to lowering the costs of production. Continuous cell culture technologies can be used in the manufacturing of both stable and unstable biological molecules. The US FDA has been supportive of the implementation of continuous manufacturing using a science- and risk-based approach.

This week WuXi Biologics’ offer Hang Zhou, Ph.D, Director of Cell Culture Process Development and Sherry Gu, Ph.D, Vice President of CMC Management as two industry experts in applied continuous manufacturing approaches to address any questions you may have related to the adaptation or implementation of continuous manufacturing strategies for protein therapeutics.  WuXi Biologics has developed a continuous processing platform for biologics manufacturing using single-use bioreactors and have been successful in the development of multiple continuous unit operation steps both at small development scale and for large-scale GMP manufacture (1,000 L perfusion cell culture).

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