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.

Recombinant Therapeutic Proteins (RTPs) require correct folding and post-translational modifications for activity. While traditional random integration is simple, it often results in low yield, long timelines, high costs, and unpredictability. SSI technology addresses these issues by enabling targeted gene insertion into validated active loci via homologous recombination, advancing precise and efficient cell line development.

As the world’s first commercialized site-specific integration cell line development platform, AlfaCell has successfully delivered numerous projects for biopharma clients, including monoclonal antibodies (mAbs), bispecific antibodies (BsAbs), fusion proteins, antibody-drug conjugates (ADCs), and other difficult-to-express proteins. mAb titers have reached 6–19 g/L, while BsAbs have achieved 5–13 g/L with mismatch rates below 20%. Cell lines developed using the AlfaCell platform have already supported clients in obtaining implied IND approvals from both the NMPA and the FDA, enabling progression into clinical trials.