Cell Line Development Process
KBI can apply established mammalian and microbial recombinant protein expression systems to provide rapid cell line generation services using:
- CHO-K1, CHO-S, CHO-DG44, HEK293
- E. coli expression systems:
Insoluble (inclusion body)
Both transient expression and stable pool generation approaches are available to support proof-of-concept (POC) material generation for preclinical programs designed to meet the client’s timeline and budgetary objectives.
Our Cell Line Development services include:
Our stable cell line development activities are performed as stand-alone services or are fully integrated into larger scope process development programs. Selected cell lines are used for the generation of KBI internal research cell banks (RCBs). For full scope process development and cGMP manufacturing programs, the master cell bank (MCB) generation is outsourced to established third-party vendors. KBI conducts the quality audit of a vendor, transfers distribution vials of the selected RCB to the third party facility, manages and provides quality oversight of the pre-bank testing, the MCB production, testing and release under cGMP.
Custom Cell Line Development:
Additionally, KBI offers reporter cell line generation for cell-based assay development programs. These programs range from pre-clinical method transfer or development to cGMP qualification and validation in support of clinical and commercial Drug Substance and Drug Product release and stability testing.