Developing a Production Bioreactor Scale-Down Model to Facilitate Continued Process Verification of a Commercial Biologic

The ICH Q11 guideline recommends that small-scale models can be developed and used to support process development studies. A scientifically justified model can enable a prediction of quality and can be used to support the extrapolation of operating conditions across multiple scales and equipment. A qualified small-scale model can also be used to support process investigations and improvements, working cell bank performance verification and next-generation process development studies.

Arguably, commercial biologics manufacturing processes developed at the turn of the century followed a ‘traditional approach’ to process development. Such processes require extensive laboratory support during the product lifecycle to improve process understanding due to limited process characterization performed prior to market application. The success of product lifecycle studies requires the development and qualification of appropriate small-scale models.

Avid Bioservices has many years of experience in developing both processes in‑house, as well as successfully transferring processes manufactured at other production sites. In this webinar, a case study will be presented to describe the development of a production bioreactor scale-down model to support process improvements and continued process verification of a commercial process at Avid.

Speaker

Eddie Crabbe, Senior Director, Process Development, Avid Bioservices in Tustin, California

Eddie holds a PhD in Food Science and Technology from Kyushu University, Japan and MS in Biochemistry from the University of Ghana. He has extensive industry experience supporting microbial and mammalian upstream processes from early stage process development through to commercial manufacturing for biologics and biopharmaceutical drug substances. His scope of expertise includes continuous process verification, next generation process development and characterization, regulatory filings and external manufacturing support.

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