Risk mitigation and process debottlenecking in continuous biomanufacturing

Risk mitigation and process debottlenecking in continuous biomanufacturing with in-time delivery/release and E-data integration to enable continuous biomanufacturing

Higher titers in monoclonal antibody processes and newer cell & gene therapy products have introduced various new technologies into the biopharma market. While these new technologies have furthered the field as a whole they have also generated several new challenges in raw material management from a regulatory, quality and supply chain standpoint. The manufacturing process innovation that leads to increase in flexibility while decreasing overall drug product cost can help meeting some of the market challenges. A lot of progress has been made to improve upstream to downstream unit operations.

However, many challenges need to overcome to implement well-functioning fully integrated continuous manufacturing. Typical biologic manufacturing consumes hundreds of raw materials including media, supplements, process chemicals, filters, resins, and excipients. Managing the flow of these components and releasing them on a timely basis is a daunting task without either increasing inventory levels or implementing a non-traditional approach to receive release. Using these materials while meeting all quality and regulatory requirements and predicting process variations are key to de-risking the manufacturing process. In this presentation we will present some case studies of issues in raw material management and discuss various options with risk and benefit analysis to overcome some of these challenges.

This presentation was given during BPI Boston, September 28, 2022.

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