Arranta Bio’s President and Chief Operating Officer Dave Stevens discusses how the company is tackling the fragmented mRNA supply chain by integrating production, as well as the challenges facing this new technology and how it unlocks the potential for cancer vaccine development.
David Alvaro (DA):Why do you believe so few CDMOs are offering the supportive services needed for mRNA programs?
Dave Stevens (DS): Right now, the supply chain for mRNA production is incredibly fragmented. Each of the individual steps requires a lot of specialization, and very different skill sets are needed for each of those steps. If you think about the raw materials that are required, the mRNA enzymatic reaction through to the liquid nanoparticles (LNPs), and the finished drug project, which is an injectable — there’s a lot of complexity from start to finish. It’s very difficult to do all of those things well, which has presented an incredible challenge for any product innovators in this space.
DA:How do clients benefit from the integrated approach that Arranta Bio is taking to mRNA vaccines by providing the full range of manufacturing services under one roof?
DS: We’re able to bring all of those different elements together because of the engineering and the configuration of the facility: all of the raw materials, the actual mRNA enzymatic reaction in bioreactors, the purification downstream process, as well as the LNP formulation, and, at the finish, the injectable drug product. What’s really complex in particular is the LNP formulation piece, which requires an enormous amount of solvent handling, and, in many facilities, that’s a challenge. However, being able to immediately take the formulated product and fill it into the finished injectable sterile drug product is incredibly valuable to clients.
Additionally, by integrating all processes, we simplify the supply chain. Suddenly, instead of managing four or five different vendors, you’re managing a single organization, which takes control of all of the scheduling requirements and eliminates a lot of that complexity. We think that’s an incredibly beneficial aspect. We’re also very interested in the potential of vaccines to prevent cancer. This process would work by first sequencing the DNA of a cancer tumor, and then –– just 60 days later –– we would be able to provide a product to address that specific, individual tumor. It’s an incredibly powerful technology.
DA:How unique is the robotic flow system that you’re implementing, and how will it benefit your clients?
DS: The Vanrx system is a tremendous technological advancement for the final product. I have been involved for a number of years in injectables sterile drug product, and one of the biggest challenges has always been the need to have operators involved in the process. The Vanrx system allows us to completely eliminate the source with the greatest potential to contaminate the product, as it’s an entirely isolated Grade A system consisting exclusively of robotics, with no human operator involvement whatsoever in the final process. It’s an incredible way to improve the sterile assurance of the product and make sure that we deliver medicine to patients safely.
DA: Are you planning to offer manufacturing of mRNA vaccines all the way through to commercial scale?
DS: Yes, and that’s one of the best things about our facility and the flexibility that we have within the Arranta network. We have an enormous amount of physical capacity that we can configure for clients. Our current plan is to support mRNA pioneers to take their products clear to commercial supply –– phase I–phase II, then phase III, and then into licensure. With that, we’ve already done a lot of engineering work, and we know that we can scale capacity easily within the facility in our network. Certainly, our goal is to take clients all the way through to commercialization and supply medicine to patients.
DA: The flow system is part of a broader Danaher process technology platform that Arranta Bio is implementing. Can you tell me a little bit more about that platform and what makes it unique?
DS: What Danaher has done is to put together a suite of technology that has bridged those individual steps; it’s actually the best in class. The Cytiva brand that’s part of that provides a lot of the process equipment we need to do some of the upstream work, in particular. The company has also acquired Precision Nanosystems, which provides a technology solution to the LNP formulation process. In addition to that, they also have the Vanrx system. By assembling all of these assets in the same facility, we can integrate that and provide automation, which should generate a superior product for our clients. It’s a really interesting value proposition, and it’s exactly what Arranta Bio needs to achieve our goals in this space.
In the role of Chief Operations Officer, Mr. Stevens is responsible for Arranta’s operations functions, including laboratories, manufacturing, client program management, and engineering. Mr. Stevens brings over 20 years of broad international operations and commercial experience in the CRO and CDMO sectors. He was formerly the Senior Vice President & Head of AMRI’s Drug Product business unit, and previously held senior leadership roles at AMRI and Aptuit. Mr. Stevens holds an MBA in strategy, finance, and marketing and an undergraduate degree in business from the University of Edinburgh.