Vaccines and biologics driving Charles River investments
The contract research organisation (CRO) has worked on vaccine development for decades, but industry’s unmet vaccine needs coupled with an increased shift towards biologics has seen Charles River adapt and broaden out its services.
“We've simply seen an increased demand in the market for biologics, and we have responded with increased investment in vital aspects of the business—including our vaccine manufacturing, and cell banking and viral clearance suites,” Jim Gombold - site director for the firm’s Biologics Testing Solutions unit – told this publication.
Over the past twelve months Charles River has “doubled [its] vaccine manufacturing capabilities and added two new suites for mammalian cell banking, in Malvern, Pennsylvania,” he continued, adding the firm’s viral clearance suites in Cologne, Germany, have upped capacity by 30%.
“[We’ve also] set up an in-house in vitro bioassay research and development group in Erkrath, Germany. In vitro bioassays are vital in potency determination, which is necessary for regulatory submission and lot release of all biopharmaceutical products.”
Demand for such services is likely to trigger further investment at Charles River, with Gombold telling us the firm intends to follow the market to provide a comprehensive portfolio of services for its clients.
“In that spirit, it makes sense for us to continue expanding along the spectrum of services in pharmaceutical development.”
This includes biosimilar development which – following the approval of Sandoz’s Zarxio last year and Pfizer’s Inflectra last week – is beginning to blossom in the US.
“As more biologics are developed and approved, it will only follow that biosimilar production will increase. Because biologics are manufactured in living sources, the process for determining the therapeutic equivalence of a biosimilar is complex,” Gombold said.
