ProteoCell’s platform is based on providing the best in vitro expression system for recombinant protein production. The priority is not the use of a specific cell line, but rather working to identify the best expression system for the needs of the project at hand. ProteoCell’s scientists are equally versed with bacterial, yeast, and mammalian expression technologies. Once the appropriate system is selected, then ProteoCell continues to develop the optimal custom bioprocess platform required.

By overlapping the processes of cell line development and bioprocess development, ProteoCell is able to screen the best, most stable, and most productive recombinant clone with the optimal bioprocess to produce it. This work package can be completed in a combined period of less than six months for both cell line development and bioprocess development for a mammalian cell line. ProteoCell uses either present off-the-shelf expression and cell culture systems, or provide its own, ProteoCell SSI, which allows for the development of the best expression/production conditions. ProteoCell also has capabilities to develop yeast and bacterial cell line based bioprocess platforms.

Cell Line engineering technologies in use at ProteoCell emphasize the flexibility of the work package from Construct generation to cell line generation, to eventually bioprocess platform, typically at ≤5L scale. 

ProteoCell SSI Platform Quick Facts

Cell Line Engineering

» Flexibility: Vectors and transfections for both Stable Cell lines and/or side-by-side expression analysis in a predefined environment (comparability studies).

» Speed: Isolation of single clones in culture in less than 3-4 weeks.

» In-house CHO DG44 DHFR- production- ready high performance cell lines with proprietary ProteoCell SSI vectors.

» Preliminary clonal candidates with initial productivity of 1-2g/L.

» Clonal selection integrated with preliminary process development to validate clonal candidate in a bioreactor before cell banking.

Process Development

» Flexible process development parameters depending on clinical and commercial targets. Optimal process development based on project URS.

» Rapid scale-up: Pre-screened and developed skeleton that can absorb new molecule quickly

» Master Cell Bank (MCB) with fed-batch productivity post PD of 3-5g/L, depending on project parameters (validated in a bioreactor).

» Chemically defined cell culture system, regulatory compliant, and ready for scale-up.

» PD in two stages for additional flexibility: Stage 1=Advanced PD. Stage 2=Process Scale-up.

» Full suite of CTD-ready documentation for cell line engineering and process development for selected clone.