Cognate BioServices, Nucleus Biologics Form Cell & Gene Therapy Partnership

Cognate BioServices, a global contract development and manufacturing organization (CDMO) in the cell and gene therapy industry, and Nucleus Biologics, have formed a partnership for custom and commercial medias and delivery systems for cell and gene therapy clients.

"We're quite excited to be moving forward with Nucleus," said J. Kelly Ganjei, chief executive officer, Cognate. "I am particularly pleased with this collaboration that has come to us from the front lines of product development. Seeing an opportunity to simplify the supply chain, our sales and business development team seized this opportunity. I applaud my team and Nucleus for their creativity and vision in getting this partnership off the ground."

Nucleus' AI formulation platform creates an optimized media offering that will allow Cognate's clients to reduce time in development and towards large scale production. The partnership between Cognate and Nucleus will improve stability, reproducibility and supply-chain integrity for clients by enabling an on-demand supply of proprietary media from clinical to commercial scale. "Nucleus' approach is a game changer in cell and gene therapy manufacturing," added Mr. Ganjei.

This partnership will focus on both clinical and commercial clients, especially as Cognate expands its business with both allogeneic and autologous on-demand cell and gene therapies. The Nucleus platform is unique within the cell and gene therapy supply chain and provides a scalable solution to rapidly formulate optimized media and receive custom media lots. This remarkably robust platform will enable Cognate to rapidly implement this technology across its global capacity network.

"We're eager to get our partnership with Nucleus out to the market," said Mike Stella, chief business officer, Cognate. "Nucleus' product pipeline will improve stability, reproducibility, and reduce time to large-scale production. Critical components like media have been front and center for a while in our industry, but the constraints have been further amplified with COVID. We believe this will become another key differentiator for our business."

David Sheehan, president and chief executive officer, Nucleus Biologics, said, "We are grateful for the opportunity to work with Kelly and his team at Cognate. Cognate understands the industry, the clients' needs, as well as the urgency with which the industry must create a new paradigm for media. Our approach promotes therapies getting into the clinic quicker, safer and more reliably, with less supply chain risk, and ultimately results in patients getting product more timely. We are laser focused on building disruptive products, especially as it pertains to the supply chain of advanced therapy developers, and we are excited to have Cognate as a partner."