With therapeutic monoclonal antibodies (mAbs) becoming a predominant class of new drugs developed in recent years, there is an increased emphasis on speed-to-clinic for such medicines that can address unmet clinical needs. As a result, a major focus area for the biopharmaceutical industry has been the shortening of product development timelines to bring a molecule to the clinic for the first time. By using platform technologies and strategies, the process and product development teams at biopharmaceutical companies have been able to significantly reduce the Phase I production timelines for mAbs.<br/><br/>Despite the streamlining of workflows and implementation of platform strategies, an unprecedented, global event like the COVID-19 pandemic can pose severe, unforeseen constraints and challenges to the development timeline of a mAb. Occurrence of the COVID-19 pandemic in 2020-21 warranted several changes in the overall approach to the Phase I development of a mAb to ensure minimal impact to overall project timeline.<br/>This talk will discuss the downstream development of a mAb through the COVID-19 pandemic. Specifically, the work will demonstrate the acceleration and execution of process development activities while navigating the associated risks and challenges, both technical and logistical, presented by the pandemic and responding quickly to changes. Examples of challenges and considerations encountered during development include: a) technical issues such as disulfide reduction and host-cell protein clearance impacting polysorbate excipient stability, b) supply-chain issues affecting the on-time delivery of raw materials (e.g. resins and filters) and subsequent impact on process development and manufacturing, and c) logistics of carrying out end-to-end development & manufacturing in-house vs. outsourcing and additional considerations for the latter. Finally, we will discuss the overall approach, risk mitigation strategies and the lessons learnt that can be applied to future molecules undergoing Phase I development.

Speed-to-clinic and phase I clinical development of a monoclonal antibody therapeutic during the COVID-19 pandemic

ACS Fall 2021

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.