Fluorescent Site-Specific Integration
Cell Line Development
The site-specific integration cell line development platform, AlfaCell, integrates fluorescence-based visual selection with site-specific integration (SSI) technology to enable precise insertion of genes of interest into stable, high-titer, and high-quality genomic hot spots. The platform enables rapid generation of high-yield and stable cell lines within 1.5 months, and early prediction of product quality within 1 month, empowering clients to accelerate the development of cell lines ready for large-scale industrial manufacturing.
Advantages
Services
Case Study
Proven High-Titer Expression
Reliable Correct Pairing
Applications
Monoclonal Antibody
Stable integration ensures consistency in key quality attributes (CQAs), including charge heterogeneity and glycosylation modifications, across production batches.
TCE Drug
The AlfaCell platform completed the cell line development for this TCE drug, achieving a titer of 5.6 g/L and a correct pairing rate of 84%.
Four-chain BsAb
Nano Bispecific Antibody
Within just 3 months, GBB completed stable cell line development for Co. B's nano bispecific antibody. The top-performing cell line achieved a titer of 15.6 g/L, successfully meeting and exceeding the industrial production target.
Site-Specific Integration Unlocks Step-Change
After adopting AlfaCell’s site-specific integration technology, the bispecific antibody achieved a titer of 4 g/L within just 1.5 months, with a favorable growth profile.
Parallel Cell Line Development Prior to Final PCC Confirmation
Based on the results of AlfaCell transient expression (molecules + optimized plasmids), the AlfaCell platform constructs and screens stable cell lines for multiple molecules in parallel. The platform’s unique "Double-Fast" advantage enables obtaining high-titer and stable cell lines within 1.5 months and rapid prediction of product quality within 1 month, allowing early planning for subsequent process development and capacity expansion.
Seamlessly Connect CDMO and Commercial Production
Designed for easy transfer, ensuring partners can reproduce high yields.
Case Study: Fast CDMO Transfer within 1 Month
· After the cells recovered their viability, the density growth was essentially consistent with the viability.
· The VCD for both 1F12 and E6 was higher than the client's, and the viability trends were essentially consistent.
· After adjusting the glucose feeding strategy to feed to 6g/L when it drops below 4g/L, the trend returned to normal. (Previously, the strategy was to feed to 9g/L when it dropped below 6g/L).
· The LAC/OSMO trends were normal, with LAC being slightly higher than the client's.
