The purpose of the DNA2MCB service package is to provide the complete cell line development program up to research cell bank (RCB) delivery, including in-depth analytical protein characterization of the top clones. This is followed by performance assessment in bioreactors and the preparation and release of the master cell bank (MCB).
Our standard DNA2MCB approach delivers the MCB in 9 months* and includes:
- Gene synthesis: preparation of the sequence and DNA synthesis, followed by sequence confirmation.
- Vector cloning: cloning of genes into Sartorius’ expression vector, followed by sequence confirmation.
- Transfection and clone generation: vector transfection, large pool generation, single-cell cloning, early identification of high producers (by productivity assay and AI/ML predictive modeling), and high-throughput small-scale fed-batch assessment.
- Clone evaluation: Ambr® 15 clone evaluation in 14-day fed-batch culture.
- RCB preparation and testing: top four clones selected based on cell growth KPIs and titer.
- Stability studies for top four clones: data package of clone performance in batch and fed-batch modes.
- Process confirmation in 5 L bioreactor: data package of clone performance in bioreactor and process transfer protocol.
- Full documentation package including the single-cell cloning validation report.
- Delivery of 4Cell® SmartCHO media and feeds necessary for cultivation up to 3 L.
- Top clones GMP analytical screening (charge variants, glycans, protein expression, size-exclusion chromatography, etc.).
- MCB GMP manufacturing: >500 vials, manufacturing summary report, and certificates.
- MCB GMP release testing: sterility, mycoplasma, identity, adventitious agents, retroviruses, genetic characterization, species-specific viruses, and certificates for each release and assay.
- It is important to note that the scope of work described above is not exhaustive. Additional service packages (media and process optimization, process development, material production at pool and | or clone level, further protein and | or cell characterization testing) can be added and customized based on your needs upon request.
Please request a quote and contact our CHO cell line development experts to discuss how we can design a tailored project to fit your project and | or product requirements.
*For conventional monoclonal antibodies
