Charles River opens a plasmid DNA plant in the UK, Batavia Biosciences is building a commercial vaccine facility in the Netherlands, and OrganaBio’s cell therapy manufacturing site in Florida is now up and running. Welcome to our CDMO roundup.
First up this week is Charles River Laboratories (CRL), which – fresh from bagging contracts with Ziphius Vaccines and ASC Therapeutics – has opened its High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom.
The 16,000 square-foot facility aims to bolster clients’ plasmid DNA manufacturing workflows, offering turnaround times from 48 hours for off-the-shelf products to custom HQ plasmid DNA manufacturing services within five weeks or more.
“In order to address the exponential growth of the cell and gene therapy market, we will continue to broaden our reach and capabilities to meet the growing demand,” Charles River COO Birgit Girshick said. “Our Alderley Park expansion is one of multiple ongoing initiatives to support our global clients from discovery to delivery.”
The site will quadruple Charles River’s HQ plasmid DNA capacity.
Next is another contract development and manufacturing organization (CDMO) that recently featured in our news pages: Batavia Biosciences, which recently announced plans to add 22,500 square feet of viral vector and vaccine R&D capacity at its headquarters in Leiden, the Netherlands.
Now the firm is building a 12,000 square meter (130,000 square-foot) building designed to support late-stage clinical manufacturing and commercial manufacturing of vaccines and viral vector-based gene therapy and immune-oncology products.
The decision to invest in this plant is due to “the need to be one-stop shop,” Batavia told us, from R&D to clinical to market. “The expansion was part of the business case presented to and financially supported by CJ [Cheiljedang, which acquired Batavia for $226 million in November 2021].”
The site will consist of six modular production suites and fill/finish capabilities. “It is expected that we will need to hire +200 additional talent to fully operate the new facility,” we were told.
Our third CDMO is OrganaBio, which has begun GMP manufacturing operations at its 19,000 square-foot cell therapy manufacturing facility in Miami, Florida.
The plant is expected to serve custom cell therapy development and manufacturing projects, using OrganaBio’s tissue supply chains to manufacture clinical grade tissue and cellular raw materials derived from perinatal tissues and adult apheresis products for partners.
“Since our inception in 2018, OrganaBio has been focused on providing solutions that accelerate the rate at which cell therapy developers can manufacture lifesaving drugs,” said Justin Irizarry, CEO of OrganaBio.
“Our conversations with customers and partners have revealed that GMP manufacturing space, available immediately, and with flexibility to allow developers to manufacture their drugs alongside OrganaBio’s professionals, is extremely valuable. When combined with OrganaBio’s quality assurance, regulatory, compliance, and assay development services, OrganaBio provides a well-integrated manufacturing solution that affords speed and control to cell therapy developers.”