Batavia Biosciences is expanding its contract development and manufacturing organization (CDMO) services portfolio (R&D and clinical manufacturing) to include commercial manufacturing services. The company has finalized the design plans of its new 12,000 square meter building to be realized at the Bioscience Park in Leiden, The Netherlands. It is expected that the manufacturing facility will be operational around Q3 2024.

The multi-product facility is designed to support the late-stage clinical manufacturing and commercial manufacturing of vaccines and viral vector-based gene therapy and immune-oncology products. Batavia’s highly intensified manufacturing technology, HIP-Vax, which utilizes fixed-bed bioreactors, will be the main platform, but also products manufactured using traditional mammalian cell suspension technologies up to 1000L scale can readily be delivered. The facility is based on a modular design, with 6 production suites. On-site, state-of-the-art fill-finish capabilities ensure on-time delivery of drug product. Depending on virus/vector type the facility is expected to provide for several hundred million doses annually.

“This is a major step for Batavia as the company transitions from a CDMO that could assist its clients in R&D and clinic manufacturing only, to now, a “one-stop-shop” where it will be able to support clients from concept product idea all the way to full market launch and commercial manufacturing,” said Menzo Havenga, CEO of Batavia Biosciences.

Chris Yallop, CSO at Batavia Biosciences, said, “This facility provides a valuable resource to ensure the manufacture of critical new medicines including low-cost global health vaccines, epidemic and pandemic preparedness vaccines, gene therapy and virotherapy treatments.”