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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 29 Conclusion Depth filters provide an economical, efficient, and scalable solution for clarification of a large variety of mammalian cell cultures. However, clarification of lentiviruses presents challenges in terms of capacity, purity, and yield. This study explored optimal depth filtration-based clarification strategies using a suspen- sion lentivirus cell culture harvest to develop a scalable, cost-efficient, and good manufacturing practices-com- pliant process. A fully synthetic depth filter (Clarisolve 60HX, MilliporeSigma, Burlington, MA) was tested as a single-step clarification option at three different scales to provide strong and robust confidence on the overall performance achieved. The use of synthetic clarification solutions has the advantage of increased robustness, lower risk associ- ated with natural sourced raw materials, and enables an overall cleaner process. In addition, use of an ad- vanced clarification process allows high impurity removal, which is a key parameter for downstream process intensification, while maintaining high qual- ity profiles. Different feed streams of higher cell density or lower viability might require a secondary clarifica- tion step to achieve proper protection of the membrane bioburden reduction filter and this need should be as- sessed on a case-by-case basis considering all factors. This case study demonstrated that a synthetic depth filter (Clarisolve 60HX, MilliporeSigma, Bur- lington, MA) was able to achieve high performance at all scales as a single-step clarification option, al- lowing a smaller footprint and limited hold-up vol- ume losses while setting a strong foundation for the rest of the downstream process. PT Next generation Raman imaging High performance Raman systems for a range of applications Visit www.renishaw.com/raman Renishaw, Inc. 1001 Wesemann Drive, West Dundee, Illinois, 60118, United States T +1 847 286 9953 F +1 847 286 9974 E raman@renishaw.com www.renishaw.com Raman spectroscopy produces chemical and structural images to help you understand more about the material being analyzed. Renishaw has decades of experience developing flexible Raman systems that give reliable results, for even the most challenging measurements. With Renishaw's suite of Raman systems, you can see the small things, the large things and things you didn't even know were there. AD216(EN)-01-A (For inc).indd 1 12/20/2019 9:36:12 AM