Seeking Solutions for Large-Scale GMP Viral Vector Manufacturing

Abstract

Based on conversations with customers over the past several years, Univercells has identified the major hurdles in largescale virus manufacture, which include expensive manufacturing facilities, lack of expertise, limitations in the number of scalable manufacturing technologies available in the market, and the high cost of good manufacturing practice (GMP)grade reagents including transfection mix, plasmids, and bovine serum, according to Thomas Theelen, business development manager at the company. [...]the lack of standardized production platforms that support industrialized scale processes is the leading challenge," Swanson concludes. Incorporating design-of-experiment study principles and use of improved bioprocess control and data analysis software are allowing process development/optimization to be conducted at the multiparameter level, while new analytical methods, such as more accurate viral vector quantitation techniques, provide a better understanding of impurity profiles and allow for better process monitoring. Nominations were accepted in the following categories: * Excellence in Pharma: API Development * Excellence in Pharma: Finished Formulation * Excellence in Pharma: Manufacturing Technology and Equipment * Excellence in Pharma: Bioprocessing & Manufacturing * Excellence in Pharma: Analysis, Testing, and Quality Control * Excellence in Pharma: Packaging & Drug Delivery Devices * Excellence in Pharma: Supply Chain, Logistics, and Distribution * Excellence in Pharma: Contract Services and Outsourcing * Excellence in Pharma: Regulatory Procedures and Compliance.