With 15,000 square feet of dedicated GMP manufacturing space designed to provide the highest degree of segregation between suites, Arranta Bio is prepared to support a range of client projects and service the market with a state-of-the-art facility.Mike Wourms, Arranta Bio’s Senior Vice President of Site Operations, explains more about the $100 million investment in Watertown, Massachusetts.
David Alvaro (DA): Can you tell me about the level of investment that Arranta is making in facilities?
Mike Wourms (MW): Arranta invested $100 million in a state-of-the-art facility in Watertown, Massachusetts, in 2020. The facility has about 15,000 square feet of GMP suites, with each technology platform occupying a dedicated area. In addition to the 15,000 square feet of GMP manufacturing space, we provide the highest degree of segregation between product and suites. There is an integrational flow of people, materials, product, and waste — and the suites also each have a dedicated airflow.
We are also investing an additional $10 million in mRNA capacity in our process analytical laboratories, as well as in manufacturing. We’ve formally reviewed these design principles with the U.S. FDA in a Type C meeting that took place in September 2020.
DA: How are you enhancing the Watertown site to enable the manufacture of both mRNA and lipid nanoparticles?
MW: We’re dedicating several of our process development and GMP suites to mRNA and fitting them out with equipment. We expect our process development laboratories to be ready in Q4 2021, and our clinical capacity is anticipated to go online in early 2022. We’re also installing an aseptic fill-finish line that will be ready in Q4 2022.
DA: What kind of manufacturing scales are you going to be able to support for mRNA vaccines?
MW: We’ll be able to support our clients from preclinical development through commercial launch. We expect typical process development scales to be around a gram, depending on the lipid nanoparticles process and the solvent use, whereas our manufacturing scales range from 25 to 50 grams, with the potential for larger capacity if it’s needed.
Michael Wourms is the SVP, Site Operations of Arranta Bio. Mr. Wourms has more than 10 years of experience working with biopharmaceutical manufacturing of advanced therapies including viral vectors, cell therapies, live biotherapeutics, and nucleic acids. During his career, he has held roles of increasing leadership responsibility across product development and GMP manufacturing of complex biologic drug substance and sterile injectable drug product. During his early career, Mike accumulated deep hands-on experience performing research, process development, and GMP manufacturing of drug substance and sterile drug product. Mike brings extensive experience leading R&D and GMP operations, facility start-ups, capacity expansions, and establishing new technology platforms for advanced therapies. Prior to Arranta, Michael held operational leadership roles with Elevate Bio and Brammer Bio where he had responsibility for establishing and leading GMP manufacturing operations. He holds a B.S. degree in microbiology & immunology and an M.S. in pharmacology & toxicology.