ProteoCell SSI—the latest in fully integrated bioprocess solutions!

ProteoCell SSI is a unique and proprietary platform for the expression of recombinant biopharmaceutical drug products rapidly, efficiently, and in a regulatory compliant manner. ProteoCell uses a tagging and targeting cassette system to generate stable cell lines. A variety of in-house screening and expansion combinations are then used to further enhance the expression profile of the generated stable cell line. Upon the achievement of – high-level secreting cell lines, a mix of disposable and traditional bioprocess hardware is integrated into the manufacturing process, reducing the “manufacturing operation footprint” multiple-fold.

By overlapping cell line development with bioprocess development, ProteoCell is able to combine the best, most stable, and most productive recombinant clones with the optimal bioprocess to maximize its production yield. ProteoCell’s targets for this platform include yields of >1g/L for full antibodies at the initial Research Cell Bank stage, and we are presently aiming for targets ≥4g/L in optimized bioprocess systems for full antibody molecules.

For the last few years, ProteoCell has been a pioneer in the science of molecular engineering to design the best production clones possible. It has refined its system for efficiently finding the “super secretor” clone. Through the use of site-specific integration, expression “hotspots” were exploited to develop a highly effective expression system for the rapid docking of recombinant molecules. These clones are then subjected to high-throughput selection for the best and most stable clones, which are then expanded efficiently, and validated in a quasi-production bioreactor setting.

Additional methodologies were augmented to streamline the clonal selection and bioprocess development components of the platform development, always keeping in mind the dynamics of large scale manufacturing. Finally, disposable process solutions were added to the platform to complete a regulatory compliant, high producing, and highly capable manufacturing platform.

Our proprietary ProteoCell SSI manufacturing platform integrates the latest in cell line engineering and bioprocess development advances with single use bioprocess technology for the development of the most advanced and integrated manufacturing processes.

  • There are NO ROYALTIES charged for the use of ProteoCell SSI!
  • There are NO LICENSING FEES charged for the use of ProteoCell SSI!
  • Unrivaled and affordable, cutting-edge Bioprocess solutions!

Who is ProteoCell SSI for?

* Companies looking to use next generation expression systems for highly productive, stably produced recombinant proteins at a low cost.

* Small and medium size biotech and biopharma companies looking for a production platform with scalability—but without heavy royalty and licensing commitments present on the market today.

* Companies with larger and more complex recombinant proteins that are not stably expressed using traditional expression systems.

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.