SystImmune and Sartorius-Stedim have developed a robust viral filtration solution for SystImmune’s bispecific antibody molecule. As part of the development process, several pre-filters and viral filters options were selected and tested. Additionally, freeze-thaw and mock spike studies were conducted prior to live viral spiking. Results from the testing lead to the selection of the Virosart® HF (20 nm virus removal filter) as part of SystImmune’ s broad viral clearance platform required for all mammalian cell culture products. The complete viral clearance concept is composed of multiple clearance steps based on different orthogonal technologies such as chromatography, chemical and low pH inactivation, and adsorption. Virus filtration with Virosart® HF is an integral part of the orthogonal viral clearance technology targeting the removal by size exclusion of both small non-enveloped viruses (20nm) and larger enveloped viruses (&gt;50nm). The Virosart® HF is a surface-modified asymmetric polyethersulfone (PES) hollow-fiber membrane optimized for monoclonal antibodies. Based on a unique modified PES membrane, Virosart® HF provides high flow rates and superior capacity. The high packing density of the process elements combines extremely low hold up and flushing volumes with low footprint requirements The manufacturing scale process was transferred to Bali, China and confirmation runs were completed. The viral retention results of these optimization studies and supporting confirmation runs will be presented.

Virus filter optimization and transfer of bispecific antibody

2019 Spring National Meeting

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