“At ProteoCell, bioprocess starts on the bench, not in the plant…”
ProteoCell Biotechnologies Inc. is a young and dynamic company that places a premium on innovation. Our core innovations have revolved around the concepts of bioprocess integration and the translation of many which puts a premium on cutting through the excesses of drug development and commercialization to help bring new and needed lifesaving therapeutic innovations to the patient populations that need them.
How do we accomplish this? We have broken down the commercialization pathway of cutting edge biotherapeutics into an essential “critical path” that helps fuse the drug discovery and proper identification, preclinical and clinical validation processes, and commercial market approval through the use of bioprocess integration. Translating the concept of “the manufacturing platform is part of the final product” for ProteoCell means that bioprocess begins on the bench, at every point of the process, recombinant protein expression or production or manufacturing is a critical ingredient of the product development pathway. To effectively translate this into operational excellence, our bioprocess development teams are structured into an integrated “skill-set platform” that mirrors the bioprocess development pathway. The Cell Line Engineering unit is composed of a Molecular Group and Cell Culture Group, which is followed by our Bioprocess Group. These are then supplemented by the Engineering and Quality Groups. In this regard, be it the comparative analysis of different versions of the same genetic sequence on a molecular level, the different culture conditions of the process, or the specific facility design requirements necessary to manufacture the correct product, our team is versatile enough to work with you both on the bench and in the plant to make sure that the right bioprocess ingredients and conditions are available to help maximize both the safety and efficacy profile for the drug product being developed, and hopefully help in the approval process.
Being manufacturers, the development design and operational concepts in use at ProteoCell allow the company to truly be “a bioprocess specialty company” and bring into sharp focus the full spectrum of biopharmaceutical product development and manufacturing, while still allowing it to place a premium on bioprocess innovation, a key component of our platform offering. And being manufacturers also gives us a full spectrum perspective to innovate and create new and superior bioprocess solutions and technologies without the need to be a “bioprocess solutions boutique.” In most cases, the bioprocess solutions that we develop are “open-sourced” to our clients, partners, and collaborators, to make their bioprocess platform(s) without equal from the bench to the plant allowing for true and unrivaled biopharmaceutical manufacturing excellence.
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.
» 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.