In a joint effort to provide lower cost and more defined reagents and media to the cell and gene therapy market, Nucleus Biologics, The Cell Performance Company™, a leading provider of custom cell culture media solutions for the cell and gene therapy industry, has signed a manufacturing, distribution, and collaboration agreement with Core Biogenesis, an innovator in the field of recombinant human proteins expressed in plants. This agreement makes Nucleus Biologics the GMP manufacturer for Core Biogenesis’ recombinant proteins and a distributor for the cell and gene therapy market. In addition, Nucleus Biologics, along with their sister company Stoic Bio, will make these recombinant proteins available for their Krakatoa™ pod-based media manufacturing systems.
Nucleus Biologics’ disruptive approach to cell culture media, driving transparency through cloud-based tools that allow therapy developers to own their formulation, is anchored by published scientific studies that demonstrate that individual media components can improve cell and gene therapy efficacy. This transparency and individual ownership combined with the paradigm-shifting availability of sustainable, cost-effective GMP human proteins offered by Core Biogenesis’ innovative plant expression system are what make this agreement so powerful for cell and gene therapy developers.
“We are pleased to enter into this agreement with Nucleus Biologics as they share our vision that we must shift the cost structure for recombinant proteins and give therapy developers multiple sourcing options, as well as offer a sustainable alternative to conventional recombinant protein production,” said Alexandre Reeber, Chief Executive Officer at Core Biogenesis. “This agreement will allow us to not only partner with an innovator in the cell culture media field but make our entire portfolio of proteins GMP.”
We are proud to partner with the team at Core Biogenesis. This recombinant protein platform will transform the cost structure for media and give therapy developers a GMP option that is easy to develop and scale. This is one step in our cost roadmap to lower the cost of these therapies and increase patient access.”
David Sheehan, CEO of both Nucleus Biologics and Stoic Bio
The agreement also positions Core Biogenesis’ environmentally friendly protein portfolio to be utilized in Krakatoa, an innovative family of point-of-use media makers that allow scientists to manufacture their media inside their laboratory or in the bioreactor suite. The cell culture media, solubilized in Krakatoa systems, results in 65% less CO2 emissions than conventional media. Nucleus Biologics and Core Biogenesis are poised to demonstrate that developing and manufacturing lifesaving therapies doesn’t have to come with a heavy environmental cost. The first offering, GMP FGF-2 STAB will be available in Q2, but RUO samples for testing and feasibility can be purchased within the next few weeks.
With an estimated 2,200 cell and gene therapies in development, the industry needs collaborations to speed these candidates into the clinic and ultimately to approved drugs. The Core Biogenesis and Nucleus Biologics collaboration will create a truly unique service offering that will introduce a paradigm shift in development and manufacturing to the entire industry. This partnership will serve as an example of how technology and sustainability can converge to make better therapies sustainably and cost-effectively.