Microcarrier based cell culture process is becoming a preferred method of production for a wide variety of biopharmaceutical modalities such as recombinant proteins, vaccines and gene therapy. The primary motivations for adopting microcarrier based cell culture processes include high productivity, scalability and utilization of existing upstream infrastructure. Removal of microcarriers during harvesting can be a challenging task and current methods have limited scalability. Traditional clarification filters offer low microcarrier loading capacities and tangential flow microfiltration processes are capital equipment intensive and involve tedious cleaning validation. In this work we have demonstrated implementation of novel gradient synthetic depth filters for microcarrier removal. A case study for microcarrier removal using gradient depth filters for cell based Influenza was performed. The effects of various process parameters including concentration of microcarriers and loading flux on gradient depth filter capacities were investigated. Additionally secondary clarification optimization and sterile filter sizing for influenza was carried out to develop a complete clarification train. The new approach offers greater than 40% increase in loading capacity over traditional normal-flow filtration. A successful 10 x scale up of the bench scale process was carried out to demonstrate linear scalability.

Microcarrier removal using gradient depth filters: Influenza vaccine case study

253rd National Meeting (2017)

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