Bothell’s CMC Biologics expands facility to develop drugs for clinical trials

Published 12:15 am Friday, September 23, 2011

BOTHELL — CMC Biologics unveiled a $10 million addition to the Bothell biotech company’s cellular manufacturing plant on Wednesday.

The Danish company’s Canyon Park unit is a contract development and manufacturing organization that provides pharmaceutical science and manufacturing services t

o clients who are developing biotech drugs.

“Clients come to us early in research and development when they have a drug candidate that they are looking to move into clinical trials,” said Andy Walker, CMC Biologics senior director of manufacturing. “We develop the manufacturing process for the drug candidate, do much of the scientific characterization of the drug and then produce the drug to support clinical trials.

The plant expansion gives CMC Biologics the capacity to enter commercial production, Walker said. It has signed its first commercial supply agreement and expects pre-approval inspections from the U.S. Food and Drug Administration and European agencies soon.

“The significance of our expansion is that we have been working with a customer for five years and they have a drug candidate that is about to be approved for commercial use,” he said. “The modifications we made to the facility will allow us to do commercial manufacturing in addition to producing drug candidates for clinical trials.”

Last year, CMC completed a capital project to construct Production Facility 1, which features “single-use” technology and consists of 100-liter and 500-liter bioreactors.

“This is an investment we made because single-use technology is the future of our industry,” Walker said, explaining it allows the company to produce batches of different drugs much more quickly.

The capital expansion project CMC unveiled Wednesday was for Production Facility 2. It’s based around two stainless steel bioreactor lines with each line consisting of a 750-liter and 3,000-liter bioreactors. PF2 was shut down during construction while the building was gutted. It is again producing material.

“The modifications to PF2 were driven by the need to expand our capacity as well as make important improvements to ensure the facility will be able to support commercial manufacturing of biotech drugs,” Walker said. “Commercial manufacturing requires a higher level of compliance with regulations than manufacturing for clinical trials.”

On a tour of the plant, Walker showed the tight control of personnel and materials in the production facilities. Each step in the highly technical manufacturing process is segregated into separate manufacturing suites.

The manufacturing process itself takes more than a month to complete a single batch and can be divided into two parts, Walker explained. There’s the “upstream” side where genetically engineered cells are expanded and grown in a bioreactor to produce the protein used in the drug. The bioreactor is a more complex version of the fermenters used in wine and beer brewing. Then there’s the “downstream” side where the protein produced in the bioreactor is purified and prepared for injection into humans.

“At the end of the process, we typically have about 50 liters of protein,” Walker said. “The drug is shipped to another vendor who puts it into vials so that it can be delivered to the patient.”

Before the expansion, CMC Biologics was already the largest biotech manufacturing facility in Washington state based on installed capacity. As part of the expansion, CMC will add 20 new employees this year and 15 more in 2012 when the facility is operating at full capacity, said CMC Chief Operating Officer and President Gustavo Mahler.

In 2007, CMC Biologics moved into the former Icos Corp. building where the erectile dysfunction drug Cialis was developed. Eli-Lilly acquired Icos in 2007 and laid off most of the staff, but about 130 of the scientists who worked on biotech drug development and manufacturing were retained and the Icos business was sold to CMC. CMC has focused exclusively on contract drug development and manufacturing for clients.

Kurt Batdorf is editor of the Snohomish County Business Journal; 425-339-3102, kbatdorf@scbj.com.