BioProcess and Development Services
Bridging the gap between the Research bench and GMP manufacturingCrown Bioscience's Bioprocess team provide technical capabilities, to help biotechnology companies and external research programs bridge the distance between the pilot scale non-GLP production and GMP manufacturing for clinical trials. Our team enables smooth tech transfer by meeting specific criteria to ensure the production of a protein drug will be scalable, reproducible and cost-effective when manufactured under cGMP regulations. Our staff has decades of collective experience in the US and European pharmaceutical research organizations, which have directly contributed to our partners' successes in optimizing growth and production media of target cell lines, studying cell line stability, and increasing protein yields and quality.
Bioprocess/Development Expertise include:
- Transient Protein expression / Cell culture development
- Proprietary 293 and CHO suspension systems for fast production of recombinant proteins and monoclonal antibodies to Gram levels for initial bioreactor process development
- Gene and vector optimization
- Scouting for optimal expressor systems
- Serum free and cell-free culture systems to work with difficult proteins
- Stable Cell Line Development
- Cell Banking (WCBs)
- Protein Characterization Studies( HPLC,ELISA,Western,SDS, IEF)
- Purification development
- Extraction
- Protein stability study
- Preclinical Formulation
- Functional assays (see cell based assay services as well)
- Large Scale Protein Production to Gram levels
- Bacterial paste
- Cell pellets
- High titer viral stock
- Conditioned media