Olympus currently manufactures both commercial and clinical batches of its OP-1 family of products for worldwide distribution at its 180,000-sq.-ft., ISO 13485-certified facility. Olympus supports a broad range of activities including mammalian cell banking and culture, downstream processing and support in cGMP. The facility houses a two-by-2500L bioreactor suite with room for expansion. In addition to providing manufacturing services, the company is also offering a range of cGMP supporting solutions including quality assurance and control, process transfer and scale-up, and validation and regulatory support.
“While the demand for biologics has increased dramatically over the past decade, so have the challenges associated with bringing them to market — the manufacturing considerations are among the most technologically complex, regulated and risky aspects of the process. The Olympus Biotech CMO is designed specifically to address the critical needs drug developers have to increase their chances of success and find a highly experienced manufacturing partner with the expertise, flexibility and capacity to ensure the supply and consistent quality of the end product.”