High yield of clone

Using a platform fed-batch culture process that is not optimized for specific protein antibodies, the average expression level has reached more than 6.7g/L, of which the highest expression is 8.1/L, and there are 20 monoclonal cell lines with an expression level of more than 6 g/L, can comprehensively consider CQA such as protein quality, expression, process scalability, etc. to screen cell lines.

Assurance of protein quality

In the process of screening clones, quality characterizations, such as SEC, molecular weight, CE-SDS (NR), iCIEF, and glycosylation analysis (LC-MS), etc. are gradually added to ensure that the clones are highly expressed and the quality meets the requirements.

Good stability of clone

Using the 60 PDL stress-free protocol, the obtained TOP 10 monoclonal were stably passaged, and the expression level of each PDL cell decreased within 10%, indicating that the stability of the TOP 10 monoclonal was relatively stable and could be used in the later stage of 200 L or 2000 L scale-up production.