Mammalian Cell Line Development
KBI has been applying established mammalian recombinant protein expression systems to provide rapid cell line generation services using CHO-K1, CHO-S, CHO-DG44, HEK293 and DXB11. We also conduct cell line development using client’s proprietary expression systems. We have successfully completed over 40 projects for monoclonal antibody (IgG1, IgG2 and IgG4) and non-Ab recombinant proteins such as growth factors, blood factors, Fc fusion proteins and viral envelope proteins.
The key considerations for cell line development programs include:
- Understanding of business and science driven objectives related to the expression platform choice, e.g. IP status and licensing terms
- Applying established, commercially proven expression platform systems in order to streamline subsequent process development activities
- Implementing ICH Q5D and ICH Q5B guidelines
- Gene and codon optimization of the expression plasmids
- Clone selection based on product yield, quality, expression stability and cell culture performance
- Verification of critical product quality attributes by integrating extensive analytical support into early steps of the clone selection process
What we offer:
- Stable cell line generation from vector construction to research cell bank (RCB). The cGMP Master Cell Bank (MCB) generation is outsourced to an established third party vendors
- KBI conducts 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
- Cell line development activities are performed as stand-alone services or are fully integrated into larger scope process development and cGMP manufacturing programs
- Large scale transient expression with HEK293 and CHO cell lines
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