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Customized CMC solutions for bsAb & protein
Cell line development is a very important module of preclinical CMC and determines the final quality of the product.
GenScript ProBio cell line development (ProCLD) platform is consisted of proprietary vectors, wild type and antibody-dependent cellular cytotoxicity (ADCC) enhanced CHO-K1 host cells with commercial license, varied upstream process tool-box to facilitate the cell line development of bispecific antibodies (bsAbs) and protein.
180+ IND-Enabling Projects
26 IND Filings Supported
By Mar.2023
Assembly of IgG-like bsAbs with correct polypeptide chains is one of the major challenges in their production. Random assembly of distinct heavy and light chains leads to non-functional or monospecific impurities. At ProBio, we test vector ratios to maximize the correct assembly during cell pool development stage to reduce mismatches and ensure production with high yield and purity
before:single-vector System
Now:two-vector System
Fig. SEC-HPLC results shows that the ratio of mismatch of bsAb was reduced by 54%
ProCLD shows up to 8.7g/L prior to cell culture
Fig. Titer at day 13 in Fed-batch culture using platform feeding strategy, without optimization
ProCLD excellent stability in scale-up from 3L to 200L
Fig. GenScript ProBio‘s cell line shows excellent scale-up stability from 3L to 200L
Cell pool and developability assessment help to identify the potential developability risk and help to select the CMC candidates
Bio-Rad for gene pulser xcell electroporator
Solentim VIPS™ for single cell cloning
Solentim cell metric®
Kuhner shaker for ISF1-Z incubator shaker/Infors HT for incubator shaker
Ambr15 mini bioreactor
ADCC Enhanced Cell Line Development
CMC Case Study