What is a CDMO
A contract development and manufacturing organization (CDMO) is an outsourcing agency for pharmaceutical and life sciences industries specializing in the precise and delicate process of creating and bulk-producing life-changing and lifesaving drugs.
The Center for Breakthrough Medicines (CBM) is a cGMP cell and gene therapy CDMO specializing in CAR-T and viral vector, development, testing, clinical trials, and commercial production.
cGMP and ISO Compliant CDMOs
The closer a drug or therapy gets to full-scale distribution, the more costly a production mishap becomes. Mishandled or contaminated medicines can undo months or even years’ worth of research and development. A CDMO must maintain strict cGMP and ISO compliance standards to ensure every medicine created, tested, and produced is safe for the end patient.
All cleanrooms at CBM are professionally installed, tested, calibrated, and balanced to be fully ISO-certified, ensuring valid testing and safe manufacturing standards. All manual, partially automated, or fully-automated manufacturing processes used at CBM are cGMP compliant.
CDMO Tech Transfer
Most clients move operations into a CDMO out of necessity. A high-end CDMO must be prepared to adapt to and accommodate a client’s technical requirements to ensure all prior experimentations, cultures, and test samples are safely transferred.
Every client will experience seamless tech transfer when moving their operations inside CBM. From proof of concept to product lifecycle management and everything in between, CBM has the technology and versatility to fully comply with any research organization’s tech transfer specifications and requirements.