Many drug developers in the cell, cell-mediated, and gene therapy fields are faced with the daunting build-vs-buy decision, for two significant and primary reasons: capacity and capabilities.
The capacity required to bridge the clinical-to commercial transition is significant and takes considerable time and money to bring to an operational state, and many other CDMO's provide suite reservation models that don't work well for the type of product being made, or they don't have the scale of capacity required over time. Compounding this issue, experience with commercial scale-up at other CDMO's may not work for the type of products being developed. Personalized cell and gene therapy product development and scale-up is quite different from more traditional regenerative medicine cell therapy products, and the commercial readiness preparation is different as well.
Cognate's deep executive, operational, and bench experience within the cell and gene therapy fields ensure we bring the right tools for the job in your commercial readiness journey.
Cognate’s team of experts have played a material role in the submission of numerous regulatory filings around the world, from early clinical to approval across a broad portfolio of product types in cell and gene therapy. Our team has significant capabilities and experience in the clinical-to-commercial bridge, something particularly in urgent need in the cell and gene therapy areas. Our regulatory applications experience covers a number of different products, both autologous and allogeneic, including, but not limited to primary cells, stem cells, and immune cells. More specifically, we've worked with: CAR-T, TCR, MILs, DC, NK, MSC, HSC, hUC-MSC’s, and ADSC’s among others.
The CDMO model for pharma has a well-established short-term and long-term value proposition, but many of today’s CDMO’s in the cell therapy world have not yet delivered on that same value proposition. Cognate invested significant capital and spent several years building the capacity and capabilities to support our client’s pre-commercial inspections and commercial production, and we are still working to expand capacity on a rolling basis.
Whether you are in Phase I - Phase III, or have an approved product, Cognate can help with all aspects of your clinical and commercial manufacturing needs. Reach out to us and let’s work together to ease your commercialization worries and create your own individualized value proposition.