As drugmakers advance a wave of new cell and gene therapies, contract manufacturers have captured a larger share of the biopharma spotlight in recent years as they push to meet ever-increasing demand.
Charles River Laboratories is no different. The CDMO prides itself on its viral vector manufacturing and its expertise in adeno-associated virus production. During an open house in April, the company had a chance to show off its recently acquired site in Rockville, Maryland.
The manufacturer took over the lab from Vigene Biosciences in 2021 after putting down $350 million to buy the gene therapy CDMO. Since taking over the site, Charles River has been busy “working to modify the space,” Karen Doucette, cell and gene therapy navigator at the Rockville site, said in an interview.
Viral vectors, which are engineered viruses used in many of these advanced therapies, have been in an industrywide shortage for years. Doucette says the problems center around a lack of materials, capacity and trained personnel required to produce them.
For its part, Charles River says the Rockville site is one in its network helping churn out viral vectors.
The lab was originally designed to carry out phase 1 research, but many of Charles Rivers’ clients would rather take the whole journey, from early- to late-phase research. That meant the company still has to modify the facility with “a small build-out,” site director Beth Tebeau said.
Around 130 staffers currently work at the site, and Charles River plans to add about a dozen this year. The company also plans to expand one of its four process suites to support clients in later-stage testing.
The company's capabilities with advanced therapies are certainly being noticed. Just this week, for example, Charles River teamed up with Korea's Curigin on manufacturing for an oncolytic RNAi gene therapy.
While Charles River feels comfortable fitting its business in its current space, its current capacity “isn’t the end all be all,” said Tebeau. The evolving nature of the industry includes changes to regulatory standards that the lab has to keep up with, as well.
Meanwhile, as gene therapy manufacturing becomes more standardized, Doucette predicts that some pharmaceutical development companies could begin to bring manufacturing in house. But that’s not where the industry is right now, meaning the CDMOs can continue to bring value with their offerings, according to the Charles River executive.