As part of an orthogonal viral clearance strategy for protein therapeutics derived from animal cell lines, manufacturing processes has added virus filter (VF).  These VF provide size-based exclusion of viral particles. During process development of an antibody-based therapeutic, poor hydraulic performance was observed at the VF step.  The leading hypothesis focused on one of the impurities in the drug substance process leading to filter fouling. The process impurity was isolated for HD-X mass spec analysis and was determined to be partially unfolded and aggregation prone. Experiments were conducted with a new polishing resin to reduce this impurity level and assess the impact on VF permeability. The results confirmed that removal of the impurity significantly increased VF permeability.   Introduction of the new resin allowed for the reduction of a number of downstream unit operations in comparison with existing process. In addition, better product quality, improved potency, increased productivity and lower COGM were observed. Results from this work will be presented and discussed with a perspective on biomanufacturing challenges for non-mAb modalities.<br/>

Leveraging process understanding for downstream process development of an antibody-based therapeutic

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.