Arranta Bio, a contract development and manufacturing organization (CDMO) supporting advanced therapy pioneers, unveiled plans to establish contract manufacturing capacity for messenger RNA (mRNA) vaccines. Arranta will offer the first end-to-end platform for full integration of cGMP manufacturing of critical raw materials, in-vitro transcription, mRNA purification, LNP formulation and sterile fill/finish all within its Watertown, MA facility. Arranta intends to support product innovators using an mRNA platform to develop vaccines, for example, vaccines targeting infectious diseases, as well as therapeutic vaccines, such as those targeting cancer.
 
mRNA vaccines are a relatively new class of vaccines. Prophylactic vaccines have been recently validated with the successful commercialization of COVID-19 vaccines, while therapeutic immuno-oncology focused vaccines offer significant promise to cancer patients. This latter class of mRNA vaccines works by encoding single or multiple tumor antigens that stimulate a specific immune response and produce anti-tumoral immunity.
 
“Arranta Bio is building a team with deep expertise in analytical and process development, and GMP manufacturing to support clients in this cutting-edge sector that is poised to transform vaccines for infectious diseases and cancer treatments” said Mark Bamforth, executive chair and CEO of Arranta. “We are delighted to be able to expand access to provide best-in-class mRNA capacity with the first end-to-end platform in a single facility. Arranta’s leadership team has a track-record of establishing commercial facilities and has supported successful FDA approvals for dozens of biopharmaceutical products and are committed to support mRNA vaccine innovators.”
 
In 2020, Arranta completed the built-out and commissioning of an 80,000 square foot commercial-ready facility in Watertown, MA, with Grade C (ISO 7) clean rooms, which are suitable for the production of mRNA, lipid nanoparticle formulation and sterile fill/finish into vials within isolator technology. Arranta will have drug substance process development and formulation development capacity in place by the end of 2021 in existing laboratories and GMP clinical manufacturing by early 2022 from existing clean rooms which are already qualified. Integrated isolator technology will be installed and operational in the second half of 2022 to complete the end-to-end platform. Additional suites are available to meet client needs, including dedicated custom capacity options.
 
Arranta has an established bacterial manufacturing platform for live bacterial pharmaceuticals (LBPs) targeting the human microbiome, and for fermented starting materials for use in advanced mRNA vaccines.