Identification of Process Parameters Which Underpin Robust Platform Production Processes

View PDF

Critical objectives for the biopharmaceutical industry are the creation of robust, reproducible processes which result in consistent critical product quality attributes and yields. To meet these requirements within a short time period it is important to apply platform production processes which consist of a common host cell line, expression vector, cell line development process, cell culture media/feed, process control and scale-up methodologies during cell line development, process characterization and cGMP manufacturing.

In this study we integrate mathematical based approaches with system characterization studies to refine important cell culture parameters for multiple cell lines and recombinant monoclonal antibodies to identify process parameters which underpin robust platform production processes.

Leave a Reply