It’s rare that full-sized bio-manufacturing facilities jump into the CMO market, so when Olympus Biotech announced that it was offering mammalian and insect cell culture and support services from its facility in Lebanon, NH, we were intrigued. As it turns out, the facility has quite a history in the bio-CMO field, working with a number of major pharmas and biopharmas over the years. Under Olympus’ new ownership, it’s looking to make a triumphant return.

We spoke to Peter Gariepy, Olympus Biotech’s vice president, Operations, at the Lebanon site, about the facility’s CMO history, and his own time at the company. Mr. Gariepy has worked at the site for more than 20 years, under a variety of parent companies.

—GYR

Contract Pharma: What’s Olympus’ background in the CMO business?

Peter Gariepy: Our facility in Lebanon, NH was built in 1989 and for the first 10 years, we were one of the first contract manufacturing organizations in the biotech industry. We worked with many partners making preclinical and clinical material to advance their products to the market.
Olympus acquired the facility from Stryker in February 2011 along with the OP-1 product line for bone healing applications in the orthopedic market, and we made the decision to re-enter the CMO market. This will enable us to utilize our expertise in manufacturing biotherapeutics and employ capacity at the site. During the past ten years, the site has been very focused on commercial production and clinical manufacturing of the OP-1 line.

CP: What services do you have available?

PG: Capabilities include cell banking, process transfer/scale-up teams, cGMP manufacturing, downstream purification, quality assurance and control; process transfer and scale-up; and validation and regulatory support. It’s a 180,000-sq.-ft. site with 130 employees. We have a production suite with two 2,500 L mammalian bioreactors and a 1,000 L bioreactor, with room for expansion. We plan to add clinical aseptic fill/finish capabilities (hand-filled) in 2013.
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.

CP: Was the facility always owned by Stryker?

PG: No, the facility was built by Verax Corp. That was bought in 1993 by Creative Biomolecules, which was partnered with Stryker. In 1998, Stryker acquired Creative and became Stryker Biotech.

CP: Do you have staff that were there from the early days?

PG: We do. Including myself, we have people who have been there for more than two decades, going back to our first CMO incarnation. There’s a lot of experience on site. At least 30% of our staff has been here more than 10 years.

CP: What client base are you looking to attract?

PG: We’re very 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.

CP: Any insights yet into how the CMO business has changed from those days?

PG: During the past 20 years the CMO business has evolved, along with the biotech industry as a whole.

For example, we used to search for “disposable” buffer vessels or chromatography fluid paths. Today, single-use technology is very common and easier to integrate into our operation. Also, quality and regulatory systems are much more robust and integrated throughout the business. Overall significant improvements have been made in production titers/output and control systems for process equipment and the facility infrastructure.

As a whole, we have benchmarked within and outside of the biotech industry, integrating a culture of operational excellence and driving continuous improvement in efficiency, impacting the overall cost and quality of the process in a highly positive way.