Outlining Successful Steps for Scale-Up and BLA Filings

All partners, which could include biotechs, bio/ pharma companies, and CDMOs, must understand and agree on the goal, the process, the development plan (includSTÉPHANE ing potential deviations), production, and manufacturing. Starting a project with microbial fermentation is quicker and easier than using mammalian cells because microbial cells are easier and more convenient to access. Because a plasmid is used in these situations, there is no need to select a particular clonal line; thus, the upstream function is easier and quicker when working with bacteria. Corrosive buffers can be prepared and used in single-use plastic bags for small batch production at an early stage, but, when it is time to move to larger stainless steel equipment, single-use bags cannot be used. [...]microbial manufacturing requires customized processes for each specific molecule, and, therefore, working with multiple partners can lead to potentially unwanted surprises, such as additional plant adaption, a higher level of capital expenditure, longer batch and cycle times, and a resultant higher cost of goods.