Kevin Vedvik, Michael Hobbs, Rica Bruinsma, and Cordes Cooper, Life Technologies Corporation
Life Technologies™, a global biotechnology company, enables researchers by providing tools that accelerate scientific and medical advancements. A number of these tools are comprised of complex biological systems or isolated components used to model these systems in vitro. JMP® Statistical Discovery software has become an integral tool for helping us describe and control the complexity in our products. Our enriched understanding has enabled us to deliver whether designing a robust manufacturing process or improving product reliability for our customers. In this presentation we describe a project where loss of antibody was observed in recent batches and our approach to stabilize the product through reformulation. The team used a sequential approach to experimentation to identify possible process/formulation changes that would minimize the loss of antibody. Fractional factorial modeling followed by a Response Surface Method design were used to optimize the system and make practical decisions on the path to improvement. The new formulation was manufactured in pilot lots and tested to verify that the production material would be consistent with the predictive model. Finally, the new formulation was implemented and control measures put in place to monitor the effectiveness of the process.