Olympus Biotech, an Olympus Corporation company, today announced its new Contract Manufacturing Offering (CMO) at its state-of-the-art facility in Lebanon, New Hampshire. The move is designed to address the rapidly growing demand for biomanufacturing capacity and expertise in the pharmaceutical and biologics industries.
“The increasing number of monoclonal antibodies and recombinant proteins in the market and in development has fueled a need for experienced, sophisticated manufacturing partners that can support pre-clinical through commercial production,” said Peter Gariepy, Vice President, Operations. “Our highly skilled team, history of successful alliances and strategic flexibility position Olympus as a partner of choice for companies focused on bringing innovative new biopharmaceutical products to market. Additionally, our offering provides potential partners a proven quality system and regulatory inspection record.”
Olympus currently manufactures both commercial and clinical batches of its OP-1 family of products for worldwide distribution at the 180,000-square-foot, ISO 13485-certified facility and is offering potential partners support in a broad range of activities including mammalian cell banking and culture, downstream processing and support in Current Good Manufacturing Practices (cGMP).
At present, the facility houses a two x 2500L bioreactor suite with room for additional expansion.
In addition to providing manufacturing solutions, Olympus Biotech is also offering potential partners 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,” added Gariepy. “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.”
Olympus Biotech is immediately welcoming partners and will be exhibiting at the BioProcess International Conference in Providence, Rhode Island on October 8-11, 2012. Please visit booth #508 or call 1-866-476-2663 for more information.
About Olympus Biotech Corporation
Olympus Biotech was established in December, 2010 as a wholly owned company of Olympus Corporation. The vision of Olympus Biotech is to improve the patient Quality of Life by developing and distributing regenerative medicines that stimulate the intrinsic healing capacity in the living body by the technological development of growth factors and biomaterials. For more information, visit www.olympusbiotech.com.