Out of the Lab, Into the Factory: Providing Cancer Immunotherapy to the Masses

At Umoja, we know that a cancer immunotherapy is only as good as the patients it reaches. We can do the best, most innovative, most exciting science at the bench, but if the manufacturing process is not scalable, the effort will be too large to ultimately meet the needs of all patients who might benefit. We need an approach that reduces costs and increases access for patients while simultaneously expanding on the recent advancements in immuno-oncology. Streamlining process development and manufacturing will achieve these goals.

That’s why as part of our mission to create innovative cancer treatments, we incorporate manufacturing as an integral part of our process from start to finish, taking efficiency and accessibility to new levels. Our reimagining of manufacturing from the ground up begins with the recent groundbreaking of our new facility located in Louisville, CO just outside of Boulder and 20 miles from Denver. This facility is an important step towards fully integrating Umoja’s platforms, giving us the potential to develop processes and manufacture therapeutics at a pace that keeps up with our scientific innovations.

Manufacturing as a therapeutic keystone

The current manufacturing models in the cellular immuno-oncology space have significant challenges. First, early generation cell therapy platforms have shown many challenges to scale to meet available demand. Companies have “solved” this problem through a combination of building internal manufacturing capabilities on a global scale and by partnering with contract development and manufacturing companies (CDMOs). This strategy allows for increased capacity, but comes at a cost. These facilities are competing with not only themselves, but also others for limited supply chain, infrastructure, and the trained personnel to run plant operations. Having overseen and led a cell therapy CDMO myself for many years, I am very thankful that these facilities  enabled the first movers, but I also firmly believe we have a great mission in front of us to unlock the potential of cellular therapies through scalable manufacturing.  

Secondly, scientific innovations and product understanding are happening faster than the current cell and gene therapy product development and manufacturing models can keep up with. Changes in manufacturing processes due to findings from lab optimization or clinical trial results are common in early phase clinical trials. Lifecycle management is an important tool we can utilize to implement these changes. However, process changes come at an increased risk to the manufacturing success through the need to retrain CDMO operators or having multiple sites attempting to adhere to the same process. Often, manufacturing improvements are not implemented to minimize risk in an attempt to expedite products to the market.  This comes at a tradeoff with suboptimal manufacturing processes leading to lack of innovation, scalability, and access for patients.

From bottleneck to opportunity

Umoja is innovating the way we think about drug development manufacturing. The manufacturing mindset starts in early discovery and builds through shared knowledge and personnel resources, resulting in a seamless transition from the bench to the manufacturing facility. By internalizing our manufacturing processes, Umoja can control the entire product pipeline.

We believe our manufacturing capabilities, in combination with the advanced properties of our VivoVec, RACR/CAR, and TumorTag platforms, puts us in a unique position to provide the benefits of immuno-oncology in a highly scalable, consistent manner. This single manufacturing facility is designed to provide thousands of therapeutic doses globally while maintaining the flexibility to efficiently implement optimized processes.

And while our current focus is on building a facility that fully integrates process development and manufacturing for VivoVec-based drug products, we believe that our RACR/CAR and TumorTag platforms offer significant benefits across a range of cell therapy modalities. With that in mind, we have built in the flexibility needed to expand into other types of cell therapeutics as our pipeline expands.

Manufacturing reimagined

Our innovative approach to drug development takes inspiration from the scenic Colorado landscape. In the pursuit of new and exciting vistas bigger than us, we remember that we climb higher—and smarter—when we go together.

We are not just investing in our process development and manufacturing capabilities with the creation of our facility; we are investing in enabling our pipeline for Umoja and the global community. The establishment of our development and manufacturing facility in Colorado is an important part of our story.  It will enable us to efficiently develop and optimize processes to manufacture innovative treatments that we believe will allow our pipeline of cancer therapeutics to treat any cancer at any time. It is an inflection specifically designed to launch our clinical pipeline forward and put patients on an expedited path toward overcoming the burden of cancer.

As we establish roots in Colorado, we are tapping into a flourishing hub of diverse scientists and engineers and capitalizing on a rich history of drug product manufacturing. Our team is already expanding with a staff of highly experienced, dedicated individuals who are aligned on Umoja’s long-term mission and eager to build it with us to benefit cancer patients. I feel very fortunate to be part of this brilliant team and look forward to unlocking the scalability challenges so far inherent to cell and gene therapies by leading the field in manufacturing innovation and execution. Patients are waiting.

Sincerely,

Ryan Crisman, Ph.D.,
Co-Founder and Chief Technical Officer of Umoja Biopharma