Outsourcing onsite: Charles River to set up testing lab at Wheeler Bio

After leading the funding round, Charles River Laboratories will implement its biologics testing lab RightSource at Wheeler Bio’s biologics drug substance plant in Oklahoma.

Charles River Laboratories (CRL) already has a connection with contract development manufacturing organization (CDMO) Wheeler, having led its series A financing round in October 2022 to help expand a drug substance facility in Oklahoma. Now CRL has decided to set up shop inside the facility.

CRL will deploy and operate platform-based satellite lab RightSource at the CDMO’s facility in Oklahoma. The firm’s quality management systems, standard operating procedures (SOPs), and testing methods will be used to support all quality control testing requirements for Wheeler and its third-party customers.

“We are not managing the manufacturing facility. We are only managing and running the QC laboratory, which allows Wheeler to focus on the manufacturing. There is complete physical, legal, and regulatory separation of the Charles River QC lab onsite and Wheeler’s manufacturing operations,” a spokesperson for CRL told BioProcess Insider.

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According to CRL, its RightSource platform is a flexible biologics purpose-built lab that provides companies with a panel of assays they require for their biologics production programs they have on site. Additionally, the firm said RightSource differs from standard staffing solutions as it brings CRL’s assays in-house, with the same quality that is used at the company’s outsourcing facilities.

“RightSource sets up and runs GMP Quality Control labs at a client’s facility so they do not have to run them themselves,” the spokesperson said.

“The client is still responsible for all of their manufacturing, but the testing is handled by Charles River. Since we have extensive experience in testing we can “drop-in” the testing infrastructure by leveraging our existing network. This reduces the setup and run-rate costs of the testing for the client. When you walk into the QC lab at Wheeler you have actually left Wheeler and stepped into a Charles River space with all of our systems and processes.”

CRL could not confirm how many members of its staff will be deployed at the Oklahamo plant but said the number “will change with the needs of the client, however our lab is 3,500 square-foot and this is the only part of the facility that is managed and run by Charles River. The rest is wholly managed and operated by Wheeler.”

The laboratory is expected to be operational in the third quarter of this year and both parties anticipate beginning the in-process and release testing by the end of 2023.