Arranta Bio Unveils Manufacturing Capability for mRNA Vaccines

Arranta Bio, a contract manufacturing and development (CDMO) organization supporting pioneers in advanced therapies, has unveiled plans to establish contract manufacturing capability for messenger RNA (mRNA) vaccines. Arranta will offer the first end-to-end platform for the complete integration of cGMP manufacturing of critical raw materials, in vitro transcription, mRNA purification, LNP formulation and sterile filling / finishing, all at its factory in Watertown, MA. 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 recently been validated with the successful commercialization of COVID-19 vaccines, while therapeutic vaccines focusing on immuno-oncology hold great promise for cancer patients. This latter class of mRNA vaccines work by encoding single or multiple tumor antigens that stimulate a specific immune response and produce anti-tumor immunity.

“Arranta Bio is building a team with deep expertise in analytical and process development, as well as GMP manufacturing to support customers in this cutting edge industry that is poised to transform vaccines against infectious diseases and cancer treatments, ”said Mark Bamforth, executive chairman and CEO of Arranta. “We’re excited to be able to expand access to deliver best-in-class mRNA capacity with the first end-to-end platform in a single facility. The Arranta management team have experience building commercial facilities and have successfully supported FDA approvals for dozens of biopharmaceuticals and are committed to supporting innovators in mRNA vaccines. “

In 2020, Arranta completed the construction and commissioning of an 80,000 square foot commercial facility in Watertown, MA, with Class C (ISO 7) clean rooms, suitable for the production of mRNA, formulation of lipid nanoparticles and sterile filling. / end in vials in isolator technology. Arranta will have drug substance process development and formulation development capability by the end of 2021 in existing labs and GMP clinical manufacturing by early 2022 from already qualified existing clean rooms. The 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 guest needs, including dedicated custom capacity options.

Arranta has an established bacterial manufacturing platform for live bacterial pharmaceuticals (LBP) targeting the human microbiome and for fermented raw materials for use in advanced mRNA vaccines.

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