The OrganaBio Blog

The Supply Brain

Addressing supply chain challenges in cell and gene therapy

Why We Do It

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.

At OrganaBio, 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.

For several reasons, the industry has turned an eye towards the use of allogeneic, or “off-the-shelf”, cell therapy approaches. In addition to widespread availability, allogeneic treatments have the potential to reduce the cost of therapies per patient due to the distribution of cell manufacturing, characterization and release costs over many doses. Development of allogeneic cell therapies continues to advance with the development of improved cell culture platforms, novel target antigens, and gene editing methodologies. Yet, supply chain bottlenecks and manufacturing capabilities present significant obstacles at the beginning and end of therapeutic development. The regenerative medicine field requires a variety of cell types and tissue sources for widespread therapies to be successful; This includes immune and progenitor cells. However, if high-quality, clinical-grade cell lots do not exist or are hard to come by, then therapeutic developers can struggle to support R&D and initiate development. On the other end, cGMP manufacturing is fraught with a number of issues around availability, cost and control. While some options to these problems exist, their availability, already an impediment to progress, pales in comparison to the demand that that will soon be upon the industry.

We see a lot of promise in the therapeutic potential of birth-tissue derived cells. There are a handful of companies providing birth tissue-derived cells for use in research. However, reliability of continuous supply, cost, and procurement of GMP-grade materials are still major challenges. What a shame it would be for life-saving cell therapies to fall short of reaching patients in need, languishing in the chasm between development and clinical translation, due to supply chain limitations. We launched OrganaBio to ensure that doesn’t happen. Equipped with a secure, proprietary supply chain and bringing to market a novel, flexible cGMP manufacturing solution, OrganaBio is well-prepared to meet the industry need for a reliable, clinical-grade cell supply that will empower cell therapy companies to accomplish their missions to change the world.

Priya Baraniak, Ph.D.

Priya Baraniak, Ph.D.

Dr. Baraniak is a proven strategic thinker, problem solver and leader who brings 20 years of expertise in stem cells and tissue engineering, coupled with a keen business acumen, to OrganaBio. Dr. Baraniak has published multiple peer-reviewed papers and book chapters on the use of stem cells and biomaterials in cardiac repair and regeneration and is routinely invited to speak at conferences.

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