To successfully develop and manufacture cell and gene therapy product requires successfully addressing challenges related to meeting the Chemistry, Manufacturing and Control requirements that are applicable to these types of products. Many of these CMC challenges are unique to these types of products and some are the direct result of the expedited pathways towards development/approval for these products that in many cases are intended to address an unmet medical need. This presentation will present CMC challenges within the context of the regulatory framework that provides guidance on how to develop solutions. There will be a specific emphasis on some focused topics including facility and equipment considerations for manufacturing cell and gene therapy products in a multiproduct manufacturing facility.
35 minute presentation, 10 min Q&A
Karen Magers, Head of Regulatory Affairs, Cell & Gene Technologies, Lonza Pharma & Biotech