Creating a Next Generation CDMO image

Creating a Next Generation CDMO

An interview with Jerrod Denham, VP of Manufacturing at Ology Bioservices
In this interview, we speak with Jerrod Denham, VP of Manufacturing at Ology Bioservices about how the company is expanding their CDMO services to include cell and ex vivo gene therapies at a new location in the San Francisco area.


Before we talk about the expansion of your cell and ex vivo gene therapy development and manufacturing services, tell me about Ology, as you are a long-standing CDMO with a great track record in the industry.
Ology Bioservices is a mid-sized, US-based, bio-pharmaceutical contract development manufacturing organization that provides high quality GMP and non-GMP services to our clients for the development and production of plasma DNA, viral vectors, cell and gene therapies, oncolytic viruses, and vaccines against diseases and cancer. We have a 183,000 square foot, state-of-the-art development and manufacturing facility in Florida that provides biologic services, including live virus vectors and vaccines, from pre-clinical through Phase 3 and commercial manufacturing up to the 2000 Liter scale. We have another 35,500 square foot building in the San Francisco Bay area, that we are using as a CDMO for cell and ex vivo gene therapy products. Currently we have over 250 employees and we expect that number to grow significantly in 2021.

What has been Ology’s track record to date with vaccine and biologics? 
We have been awarded more than half a billion US dollars in contracts for vaccines and biologics manufacturing. This has really allowed us to build the proper systems and controls, which are managed by our robust quality management system to develop, manufacture and test these products for use in clinical trials, and once approved, as licensed commercial products. We have already demonstrated success in the design and build-out of a large GMP facility with fit-for-purpose equipment to make and test these products. We have built an experienced team that is capable, creative, and collaborative while maintaining high standards for maintaining these products. We are now leveraging what we’ve built for traditional biopharma and have expanded our services and capabilities into the cell and ex vivo gene therapy industry.

Why is the time right to now offer services in cell and ex vivo gene therapy?
As the market for early phase and next generation cell and ex vivo gene therapies continues to grow, there will be an ongoing need for contract manufacturing capabilities in our industry. Right now, there continues to be a huge push with respect to autologous products, but sooner rather than later there will be an increased need for more allogeneic production capabilities. Manufacturing capacity continues to remain limited, especially for smaller companies looking for early phase manufacturing and testing capability. Most of these groups do not have the time or capital to invest in their own in-house manufacturing facility, so they are always looking for a partner to help them get critical data faster, enabling them to hit their key corporate inflection points. 
We are leveraging our globally recognized, extensive experience in live-virus, oncolytic virus and vaccine production to establish our cell and gene therapy capabilities. We have the Florida site that can be used for viral vector production both in vivo and for ex vivo use, and as I mentioned we are building out our cell and gene therapy site in the San Francisco area. 

Our leadership team also has deep knowledge with respect to the key tools and technologies that will support this industry from early phase clinical development through late phase licensure. 

Importantly, we will ensure that our cell and ex vivo gene therapy business model not only aligns with what is needed today but can also be used as a foundation for what will be required in the future. One thing that we think is needed today is better characterization. We are evaluating analytical technologies that will provide a better understanding of these products and the process. To this end, our California location includes an award-winning bio-analytical group that knows how to build strong analytics which we will leverage into our customers’ process development and manufacturing programs. 
I’d also highlight that cell and ex vivo gene therapies tend to be bespoke processes that require more flexibility than traditional biologics. Given the talent we have brought on, we will provide a level of insight and experience that isn’t readily available to many startups, and those developing early-stage products while also being able to appeal to the needs of the industry’s seasoned veterans.
What are you drawing upon from your extensive career in the cell and ex vivo gene therapy industry to create a better CDMO?
I have over 20 years of experience in the cell and gene therapy industry and have worked at three different companies developing clinical cell therapy products. I spent more than twelve years at Geron Corporation as one of the subject matter experts on the first clinical product derived from stem cells for the treatment of acute spinal cord injury. I started out as a junior research associate and ended as the senior manager of process engineering. I was very fortunate to gain a deep understanding for what is required for the development of an early phase clinical product. Following my time at Geron, I was associate director of process development engineering at ViaCyte and then I spent time at Stem Cell, Inc., a company developing human central nervous stem cells for the treatment of spinal cord injury and age-related macular degeneration. I learned a lot about manufacturing a cell therapy product line and what was necessary to understand when administering these products into patients.  
After my time at these companies, I joined Anthony Davis and his team at Dark Horse Consulting. There, I was really able to build upon my deep knowledge in allogeneic cell therapies, but also learned more about autologous cell and ex vivo gene therapies in including CAR-Ts, TCRs, hematopoietic stem cells, as well as different genetic modification strategies. I was also able to gain technical knowledge with respect to in vivo viral vectors, such as AAV and oncolytic viruses. 
While I was at Dark Horse, I worked with many of the US, EU and Pacific Rim CDMOs that are currently serving our cell and gene therapy industry. That gave me a very good understanding of what technologies are out there, what is working well, what probably isn’t and what gaps need to be filled.
Given this experience with many CDMOs, what do you think a cell or ex vivo gene therapy developer should be looking for when selecting a CDMO?
It depends on the company. Each company has different requirements dependent on their phase of development, how large they are and what they need the CDMO to do. Do they need their CDMO to be a partner for life or just a partner to kind of get them through a critical portion of their overall development?
For a company that has never manufactured a clinical product they need to find the right fit with regards to flexibility and adaptability. Going to a very large CDMO that’s been established in the cell and ex vivo gene therapy industry might not necessarily be the best fit because the innovator doesn’t know a lot about their product or process yet. And they need a partner to be able – and willing – to co-develop. If it’s a more established company looking for outside help to provide surge capacity, then that might be a different type of CDMO. 
At Ology, I expect we will probably start out working with a lot of early phase developers. The reasons for this are partly because of my extensive experience in early phase development and because most cell and ex vivo gene therapy companies are just starting out. We are positioning ourselves to work with early phase clinical products, but then be ready when a company is successful and wants a partner for the life cycle of their development program.

With this expansion, you will be bringing on new team members. What kind of skill knowledge sets are you looking for?
The one thing that I’ve learned in my time in this industry is the real strength of any company is in its personnel. And the real challenge is recruiting from what I would call a small talent pool. To address this, it’s essential that the industry trains and develops the next generation of scientists and engineers. 
We are actively hiring at both the Florida and the California facilities. In California, these new hires will really be a foundational team, contributing all of their knowledge and experiences to the mindful creation of something really great. In terms of skill sets, we are looking for folks that can work in process development, manufacturing and quality roles. We also have a need for people who are skilled in analytical development and manufacturing sciences to help support our projects once we have completed our build out. 
But while we evaluate a candidate’s hard technical skills, we are also looking for potential team members that are dedicated, collaborative and customer-first type people. This is essential to our culture. In the San Francisco area, we have access to a highly skilled and experienced talent pool given that there’s a ton of biotech in the area. And more importantly there’s a bunch of cell and ex vivo gene therapy companies and talent living and working here in the Bay Area.

Looking ahead, how do you see the cell and gene therapy landscape evolving? And what role will CDMOs play?
I think that the role of CDMOs is ultimately going to be very critical for our industry. There is always going to be a need for CDMOs, especially for early phase companies. I do think that there’s going to be a lot more tools and technologies that will automate processes and provide deep analytics. I think that CDMOs will play into that as well.  
I also think that the current methods and processes we’re continuing to work on will evolve. For example, at some point non-viral methods for gene editing, genetic modification of cells will take over, and we will see less and less viral vector modifications for ex vivo gene therapies. I won’t really say that this will change overnight, but we are already seeing companies that are using new and improved, successful gene editing methodologies for these products. 
I’d close by noting that as more and more companies enter this space, they will need to manufacture their clinical products. And we think that not only can Ology Bio be a player in the cell and gene therapy CDMO arena, we will also be a go-to resource for high quality manufacturing and testing services.

About the author...

jerrod denham ology bioservices phacilitate cell therapy
Jerrod Denham has decades of experience in building Cell and Gene therapy (CG&T) CGMP manufacturing processes and analytical methods for companies all over the world.  Jerrod is the new VP of Manufacturing & Site Lead at Ology Bioservices’ California Cell and ex vivo Gene therapy facility, in the San Francisco Bay Area.  Previously a Principal Consultant at Dark Horse for C&GT process development, manufacturing, quality and CMC regulatory subjects for 50+ international clients and at several different C&GT biotech companies,  Jerrod is known to be a highly motivated executive with proven management skills and a history of success in solving challenging CMC problems.