Cell line development is a cornerstone in the development of macromolecule drugs. Traditional methods involve transfecting vectors carrying target genes into host cells, followed by extensive screening and validation processes to obtain the cell line. This random integration process often leads to high copy numbers with poor stability and numerous unknown risks, making it lengthy and labor-intensive.

Great Bay Bio's AlfaCell platform employs site-specific integration technology, transforming the traditional, random, and repetitive process into a precise, intelligent, and efficient cell line development method. With AlfaCell, high-yield, stable cell lines can be developed in just 1.5 months.

Trends in Cell Line Development: Site-Specific Integration

Site-specific integration technology introduces target gene sequences into pre-validated active sites via homologous recombination, creating a uniform cell pool and avoiding the risks and repetitive work associated with random integration. At the BPIUSWest2024 conference, Pfizer and Genentech showcased their use of this technology to address high costs, low productivity, and long development cycles in their product development.

AlfaCell: Combining AI with Integration Techniques

The AlfaCell platform integrates AI technology with integration techniques, using high-throughput cell imaging to mark high-expression, high-quality hot spots. This approach allows for rapid acquisition of high-expression host cells by substituting marked genes.

Accelerating IND Filing with DMF Filing

AlfaCell has completed the DMF filing, enabling clients to reference the DMF number in their regulatory submissions to the FDA and other agencies. This significantly shortens review and evaluation times and simplifies submission documentation, accelerating the drug approval.

As the world’s first commercial site-specific cell line development platform, AlfaCell is not just utilized for internal R&D purposes, unlike Pfizer and Genentech. It widely applies to various products, including mAbs,BsAbs, fusion proteins, IVDs, and difficult-to-express proteins. Having delivered over 60 projects, AlfaCell’s platform consistently achieves higher yields and quality than industry averages. This includes mAb yields of 5–16g/L and BsAb yields of 5–12g/L, with mismatch rates below 20%.