Interview conducted by April Cashin-Garbutt, BA Hons (Cantab)
Please could you give a brief introduction to Olympus Biotech?
Olympus Biotech was established in December 2010 as a wholly owned company of Olympus Corporation. Olympus Biotech is dedicated to the development and distribution of regenerative medicines, an area of increasing importance and optimism. When the Lebanon, NH facility was built in 1989 it was one of the first contract manufacturing organizations in the biotech industry. Along with the facility purchased from Stryker, Olympus Biotech also acquired the OP-1 product line for bone healing applications in the orthopedic market.
Olympus Biotech has recently announced the new Contract Manufacturing Offering (CMO). Please can you explain the reasoning behind this move?
Expertise in manufacturing biotherapeutics and staff who have been with the facility since our first CMO incarnation, including myself, facilitated our decision to re-enter the CMO market. Olympus Biotech is uniquely positioned to utilize our commercial experience for both commercial and clinical biopharmaceutical production.
Why is there a rapidly growing demand for biomanufacturing capacity in the pharmaceutical and biologics industries?
The number of monoclonal antibodies and recombinant proteins in the biopharmaceutical market is increasing. This is driving the need for experienced, sophisticated manufacturing partners that can support pre-clinical through commercial production.
What sets Olympus Biotech’s CMO offering apart from the rest?
I think the key for us is that we have a breadth of experience from preclinical and clinical up to commercial production, as well as global commercial licenses. We're ISO-certified. We have a robust and proven quality system, a very successful regulatory inspection history, and a highly skilled and engaged workforce. We can work on either short-term or long-term manufacturing partnerships.
Our capabilities include cell banking, process transfer/scale-up teams, cGMP manufacturing, downstream purification, quality assurance and control; validation and regulatory support. We have 130 employees and a facility of 180,000-sq.-ft. Our production suites have up to two 2,500 L mammalian bioreactors, with room for expansion at the site. We also plan to add clinical aseptic fill/finish capabilities (hand-filled) in 2013.
How does the CMO fit with Olympus Biotech’s overall vision?
The vision of Olympus Biotech is to improve the quality of life for patients by developing and distributing regenerative medicines that stimulate the body’s intrinsic healing capacity. Overall this means Olympus Biotech’s products contribute to the well being of others. This will be emphasized further as we embark on contract manufacturing – utilizing our expertise, capabilities and excess capacity to manufacture products for other biotech companies to meet their patients’ needs by bringing new biotherapeutics to the clinic and market.
How do you think the future of biomanufacturing will develop?
Over the past twenty years the CMO business has evolved along with the biotech industry as a whole. CMOs are increasingly realigning their investment plans to focus on productivity improvements, lower costs and better asset utilization in order to continue to develop alongside the biotech industry and its changing demands. Quality control and regulatory systems will also become much more robust and integrated throughout the CMO business.
What plans does Olympus Biotech have for the future?
Olympus Biotech hopes to partner with companies that share our culture of operational excellence. We are flexible and open to opportunities to work with virtual biopharma up through full-scale commercial. We can also work with companies that already have a commercial product and are looking for additional capacity or a backup site.
Where can readers find more information?
About Peter Gariepy
Peter is the Vice President of Operations at Olympus Biotech. He has worked at the Lebanon, NH facility for 22 years. Peter has been in the industry for 24 years with previous experience at Alliance Pharmaceuticals, Verax Corporation, Creative BioMolecules and Stryker Biotech. He has a B.S. in biochemistry from the University of Vermont.