Originally published September 21, 2011 at 7:47 PM | Page modified September 21, 2011 at 7:52 PM

Biotech drug factory cultivates new business

CMC Biologics, which supplies the crucial ingredients that biotechnology companies need to pursue their high-stakes search for new drugs, unveiled a $10 million expansion of its Bothell factory that doubles its capacity and takes its business strategy to a new level.

Seattle Times deputy business editor

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Like a seller of shovels to Gold Rush hopefuls, CMC Biologics supplies the crucial ingredients that biotechnology companies need to pursue their high-stakes search for new drugs.

The company unveiled a $10 million expansion of its Bothell factory Wednesday that doubles its capacity and takes that strategy to a new level.

It was already the largest biotech drug factory in Washington state and the supplier of at least a dozen drugs for clinical trials by companies from Europe to Japan and Brazil. Now the CMC plant can make drugs in commercial quantities as well.

The expansion will add 20 people to its local staff of about 180, and another 15 hires are expected in 2012, said Gustavo Mahler, CMC's global chief operations officer. Its first commercial-scale product, announced this week, is expected to be an intravenous drug for hemophilia B, made for Inspiration Biopharmaceuticals of California.

Further expansion could begin next year, said Andy Walker, CMC's senior director for manufacturing.

It's a fairly happy outcome for a plant that was all but surplus when the company that built it — Icos, the developer of erectile-dysfunction drug Cialis — was sold to drug giant Eli Lilly and dismembered in 2007.

CMC bought the plant late that year in what Chairman David Kauffmann on Wednesday called a risky move "for a little Danish company."

But CMC's focus on contract manufacturing is apparently paying off. Since its founding in 2001, said Kauffmann, the privately owned company's revenue has grown more than 50 percent a year.

To be fair, CMC does considerably more for its clients than a Gold Rush general store.

"We actually do a lot of the core science for them," Walker said.

Its customers bring in the DNA that describes a specific complex protein, and CMC scientists transform industry-standard Chinese hamster-ovary cells into genetically engineered cells that produce the protein.

The manufacturing process then begins with a 1-milliliter vial of the cells.

Cultivated inside large stainless-steel vats with a multitude of monitors and tubes to ensure precisely the right environment, those cells will multiply 30-million-fold.

"It's very analogous to what you might see in a winery or brewery, but our level of control is much higher," Walker said.

After a monthlong growing period, the cells are harvested and the drug is separated out, yielding a handful of jars with the dissolved protein.

It's not like a 737 rolling out of the factory, joked Walker. "At the end of the day we walk a bottle across the parking lot — it's not quite as cool."

But that bottle may be worth a couple million dollars.

Each of the rooms in which CMC grows its biopharmaceuticals has a separate ventilation system, and the water used in its vats is filtered, vaporized and then stored at a temperature high enough to prevent any biological activity. Replacing the entire plant would cost as much as $50 million, Walker said.

Although the new equipment allows CMC to operate on a greater scale, it's actually not where the cutting edge of biopharmaceutical manufacturing lies, Walker said.

That would be in a smaller set of rooms nearby, where instead of growing cells in large steel vats, CMC cultivates them in single-use containers — essentially large, special-purpose plastic bags. Rather than take two days to clean, sterilize and prepare a steel vat to grow new cells, the plastic can be replaced and ready to go in just a couple of hours, he said. The flexibility and speed of that approach mean CMC's next expansion could use less stainless steel and more plastic.

"This is going to be the future of our industry," said Walker.

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