For licensed manufacturing processes, the opportunity to evaluate new platform technologies is rare due to hurdles with product comparability and potential regulatory impact. When presented with this unique opportunity, there are a few approaches one can take including: a slow build of independently optimizing each unit operation for the novel technology as an iterative process, or conversely utilizing a “one-size fits all” approach  that leverages the current manufacturing processes with scaling based on standard scaling factors (the “all in” approach).  In this example, the approach to utilize the manufacturing processes with standard scaling (surface area) was selected.  With any approach there are pros and cons.  Benefits of this approach included:  (1) optimizing speed so proof-of-concept evaluation for three antigens was completed within 3 months from equipment receipt, (2) enabling direct comparison to current manufacturing process, and (3) limiting the required process development .  During the evaluation unexpected challenges were encountered such as: steep learning curve- interfacing and overcoming challenges in the novel technology, uncovering of uncontrolled variables, and limited applicability direct comparison to current processing outputs.   This poster discusses the decision process for evaluation of a novel technology and demonstrates successful, accelerated evaluation of process modernization by the “all in” approach for three legacy vaccine products.<br/>

Going all In: New technology evaluation for legacy cell culture processes for 3 live virus vaccines

ACS Fall 2020 Virtual Meeting

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