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 . KBI offers its own in-house developed DG44 expression system as well as commercial expression systems such as the LTI Freedom CHO expression platforms. 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.

View a Typical Workflow

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

Why choose KBI for CLD service:

  • Speed: high expressing stable cell line (RCB) in 18-20 weeks from transfection
  • High yield: 1-2 g/L for monoclonal antibody (mAb) with platform fed-batch culture in shake flask
  • Stability: Long-term expression and genetic stability over 60 generations
  • Efficiency: Integrating high throughput process into single cell cloning (ClonePix 2 and FACSJazzTM), lead clone identification (AmbrTM) and analytical support (forteBIO Octet and Caliper LabChip GX II)
  • Proven: provide document to support clone monoclonality and stability
  • Flexibility: project can enter at any stage, such as stable pool generation, single cell cloning, subcloning and stability assessment
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