Development of industrial cell culture processes for production of recombinant proteins seeks high efficiency, reproducibility, and predictability. Usually the time allowed for process development is short, during which culture conditions and scale-up protocols must be defined so as to maximize cell productivity and yield while minimizing process scope and overall costs (1). Although scientific literature describes various methods that increase productivity of a cell culture by reducing and arresting cell growth or weakening cell physiology (2), the cells must be…
Cell Line Development
An Inoculum Expansion Process for Fragile Recombinant CHO Cell Lines
Development of robust inoculum expansion procedures from cell banks is crucial to successful upstream manufacturing processes. Typically, vial thaw and cell culture expansion processes follow well-established procedures. Certain recombinant cell lines, however, need extra attention and development efforts to optimize conditions for robust and reproducible vial thaw and further subculturing. Difficulties in thawing frozen cells might be clone specific or could originate from suboptimal conditions during freezing. Such conditions might not be known initially and could need further optimization at…
Vendor Voice: A New Paradigm for Bacterial Strain Engineering
From rapidly obtaining sufficient amounts of active protein in early stage development to cost effectively producing kilogram and even metric ton quantities for commercial supply, protein expression is critical at every stage of biopharmaceutical drug development. Having a high-performance protein expression platform across all stages is invaluable for the speed and success of protein and vaccine development. Historically, biopharmaceutical researchers and process development scientists have used Escherichia coli in their laboratories to generate small quantities of protein. If target expression…
Cell Cultivation Process Transfer and Scale-Up
Discovery, development, and commercialization of novel biologics frequently involve collaboration between two or more companies. In the context of these business relationships, transfer of technology from one institution to another is a crucial step that needs to be executed flawlessly and rapidly. Follow-up activities usually include the development of productive, reliable, and scalable processes and are equally important because they are usually on the critical path to market. PRODUCT FOCUS: MONOCLONAL ANTIBODIESPROCESS FOCUS: TECHNOLOGY TRANSFER (PRODUCTION) AND ANALYTICAL METHODS DEVELOPMENTWHO…