The Supply Brain

De-Risking the Path to Cell & Gene Therapy Commercialization Part 1: You Need Access to a Robust and Reliable Donor Pool

When cell and gene therapy researchers step into the lab each morning, we envision transforming what may be an early stage experiment into a clinical success. Therapeutics developers spend years working tirelessly to generate pre-clinical data so that, when the time comes, their Investigational New Drug (IND) application (or equivalent outside the USA) will be accepted by the appropriate regulatory agency, allowing the therapy to enter clinical trials. However, IND approval is just the first of many significant hurdles that therapeutics developers face on the path to commercialization.

OrganaBio was founded in 2018 by scientists and business leaders motivated to bring next generation regenerative medicine therapies to market. Since then, we have assembled a team of 16 industry veterans, from scientists and engineers with years of bioprocess and therapeutic development experience to those versed in Quality Assurance, Quality Control, Regulatory Affairs and successful business-building. Combined, we have over two centuries of experience in all areas necessary for success in regenerative medicine! Our team is passionate about expediting the development of novel cell and gene therapies, ultimately improving quality of life and/or saving lives for many. We truly believe that regenerative medicine is the future of medicine, and we work relentlessly to help our customers and partners bring their therapies to market.

At OrganaBio, we believe that nothing truly worthwhile is easy…. But we can make it easier for our partners and customers. That’s why we set out to take on a significant challenge – to alleviate bottlenecks in raw material supply and expand the limited options for cGMP manufacturing that are keeping the regenerative medicine industry from reaching its full potential. It’s no news that cell and gene therapy have witnessed substantial growth over the last decade, with the pace of innovation only continuing to accelerate. The headlines yield promising news week after week. Numerous cellular therapies are currently in clinical development, using a variety of cell types. Companies and organizations are increasingly investing money, time, and effort in this space. The engine of unprecedented therapeutic change is churning, but does the industry have the fuel to supply such growth? We want to ensure the answer is a resounding “Yes” – This is why we do it.