A monoclonal antibody has been approved and commercialized, which included the process development packages often used to understand the process variability and support the control strategy for the drug substance (DS) manufacturing process. Since its approval, the DS process has been transferred to additional manufacturing sites to ensure product supply. When performing a site-to-site commercial tech transfer, the operational parameter controls should be maintained, and the performance of the process is evaluated at the new site through process and product comparability exercises. In addition, continuous process verification and process monitoring efforts within and across the sites would be set up to ensure consistent performance and flag any process drift. This talk will highlight some successes and lessons learned with respect to performance and product quality for this DS manufacturing process implemented at multiple sites, including comments on what process understanding knowledge was known from the original process characterization package versus learned only through ongoing commercial manufacturing (and tech transfer) history.

Maintaining product quality across multiple site-to-site transfers for a commercial mAb: Some successes and lessons learned

255th National Meeting (2018)

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