As the transition step between upstream and downstream processing, clarification is an important and often complex unit operation in biopharmaceutical manufacturing. The considerations in clarification increase for a Contract Development and Manufacturing Organization (CDMO), as wide ranges of cell culture conditions, various products, and compressed timelines are typical. Depth filtration has commonly been used for clarification of cell culture and post viral inactivation pools in both clinical and commercial manufacturing; however, CDMO’s and companies throughout the biopharmaceutical industry are experiencing process limitations due to increasing cell culture densities, titers, and complexity as well as a push for cleaner materials of construction, making the use of depth filtration for clarification much more involved. The work presented here evaluates the use of a new generation of depth filters consisting of fully synthetic materials of construction, where a silica filter aid and polyacrylic fibers replace diatomaceous earth (DE) and cellulose typically found in depth filters. Transition to synthetic filtration media offers significant improvement from traditional DE-based depth filters in terms of process performance as well as implementation in cGMP manufacturing of biologics. Performance enhancements in terms of volumetric loading capacities and impurity removal over a wide range of harvests with various cell culture conditions are presented. Additionally, the impact of cleaner materials of construction on manufacturing aspects of biologics is provided. This work demonstrates the ability of synthetic depth filters to simplify process development while increasing ease of use in manufacturing over traditional DE-based filters.<br/>

Considerations for process development and implementation of fully synthetic depth filters

255th National Meeting (2018)

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