How Close Collaboration Between Analytical & Process Development Can Reduce Cycle Times and Proactively Identify Pitfalls to Improve Development Outcomes

The development of biologics for human use is a challenging enterprise that requires a wide variety of skills. Notably, biologics require complex, qualified assays to ensure that manufacturing lots are produced to specifications. The production methods are also complex, requiring specialized equipment and the control of hundreds of parameters across multiple unit operations over a period of weeks. Traditionally, assays are developed by analytical scientists and scalable production methods are developed by process development scientists. And although it is well known that analytical results are necessary to assist with process development efforts, it is not always the case that these teams work closely together as one. In our experience, a close and strong collaboration between analytical and process development scientists yields reduced development cycle times, identifies potential pitfalls early and generally improves development outcomes. This talk will present several case studies illustrating the benefits of this collaboration.