VBI has engaged Paragon Bioservices to assist with the GMP manufacture of VBI-1501A, the company's lead CMV vaccine candidate. GMP guidelines provides guidance for manufacturing, testing, and quality assurance in order to ensure that drug products are safe for human consumption.
Paragon Bioservices is a contract research and manufacturing organization (CMO) whose focus is the production of reagent-grade proteins and biopharmaceuticals for clinical use. Areas of expertise include: Vaccines, VLP technologies, therapeutic proteins, monoclonal antibodies, and viral vectors. The cGMP manufacturing space includes microbial and mammalian suites, fill-finish, and fully segregated virus facilities.
Paragon has recently constructed a facility dedicated to virus manufacturing. The 8,000 square foot space includes a state-of-the-art process development laboratory and a newly constructed GMP suite. The process development laboratories include two fermentation suites, several purification centers, and analytical laboratory and product storage space.