Olympus Biotech launches CMO services
pharmafile | October 9, 2012 | News story | Manufacturing and Production | CMO, Japan, Olympus
US-based Olympus Biotech has launched a contract manufacturing organisation (CMO) operation to complement its current focus on regenerative medicines.
The subsidiary of Japan’s huge Olympus group – best known for cameras and other optical devices – wants to make some of the surplus capacity at its facility in Lebanon, New Hampshire, that currently makes products based on the firm’s osteogenic protein-1 (OP-1) drug.
OP-1 is a naturally occurring growth factor that is used to stimulate, repair, and regenerate bone, and is sold as an implant or putty to treat poorly healing fractures.
“The increasing number of monoclonal antibodies and recombinant proteins in the market and in development has fuelled a need for experienced, sophisticated manufacturing partners that can support preclinical through commercial production,” said Peter Gariepy, Olympus Biotech’s vice president, operations.
“While the demand for biologics has increased dramatically over the past decade, so have the challenges associated with bringing them to market,” he added. “The manufacturing considerations are among the most technologically complex, regulated and risky aspects of the process.”
The Lebanon plant is an 180,000 sq. ft. ISO 13485-certified facility that makes both clinical and commercial supplies of OP-1 in two bioreactor suites, housing 50L and 250L disposable bioreactors and stainless steel reactors up to 2,500L with room for additional expansion.
It also has the capability to carry out downstream processing via depth and microfiltration, bulk aseptic filtration, ultrafiltration/diafiltration and column chromatography, and in 2013 will also offer clinical aseptic fill/finishing services for liquid and freeze-dried drugs, as well as manual fills using barrier isolator technology.
The company says it is also offering a range of cGMP supporting solutions including quality assurance and control, process transfer and scale-up, and validation and regulatory support.
Phil Taylor
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