Year: 2018-19

Company: Repligen Corporation

Liaison(s): Mike Bransby, Phillip Yuen

Spectrum, a filtration company that’s part of the Repligen Corporation and based out of Rancho Dominguez, CA, focuses on the manufacture of separation products. Being a supplier of over 2,000 products globally, Spectrum contributes in advancing the production of monoclonal antibodies, cell therapies, and vaccines, through innovation in its filtration technologies. With the increase in production of their products, its acquisition by Repligen Corporation in 2017 has served as a catalyst to expand their product profile.

Of these products, Spectrum’s hollow fiber membranes for tangential flow depth filtration (TFDF) and tangential flow filtration (TFF) can be implemented from pilot to production scale, including in perfusion systems. Perfusion has several advantages over batch and fed-batch processes which include higher cell densities and volumetric productivity. Moreover, perfusion in the N-1 stage allows for high seed inoculums and, in turn, an intensified seed train. However, due to a lack of true scale down N-1 filters in the market, the KGI Team Master’s Project team was tasked with evaluating these filters to gain the optimal operating information for high density, continuous perfusion culture systems.

Specifically, the Spectrum TMP focuses on characterizing and collecting optimal operating conditions for TFF filters of different specifications to identify their potential in scale up to production scale bioreactors. By doing so, the team hopes to address issues of filter fouling and protein sieving within the duration of projected N-1 perfusion runs.