By Terri Somers
UNION-TRIBUNE STAFF WRITER

PacificGMP, a tiny local manufacturer of biotechnology drugs, will announce today that it is expanding to 25 times its size with the help of the Chinese government.

The company, which has an 8,000-square-foot facility in Sorrento Mesa for manufacturing biological agents used in cutting-edge therapies for disease, will join a collaboration that is building a 200,000-square-foot plant in Taizhou, China. The building is expected to be completed in October.

The expansion will allow the three-year-old company to tap into a growing drug-development industry in Asia. But PacificGMP anticipates its largest client base will be U.S. and European biotechnology companies outsourcing expensive biologics manufacturing to a less-expensive labor pool.

PacificGMP's technology could also provide cost savings to biotech companies because it makes the biologics in a vessel that is the high-tech equivalent of a giant Ziploc bag that is discarded after each use.

Other manufacturers make biologics in steel fermentors that must be cleaned thoroughly after each use to prevent contamination from one product to another, a lengthy process involving skilled personnel.

PacificGMP was introduced to its collaboration partners through a University of California program, QB3, which aims to use its math, engineering, chemistry and physics expertise to drive new health care technologies.

This collaboration allows us to be on the cutting edge of really big changes in biologics manufacturing,” said Leigh Pierce, PacificGMP president and founder. The Chinese government, which is pouring billions of dollars into scientific research and commercial biotechnology, is funding the new facility with a million-dollar contribution, though the U.S.-based collaborators would not be more specific about the terms.

QB3, which seeks to help professors from UC's San Francisco, Santa Cruz and Berkeley campuses develop and commercialize their discoveries, asked Glen Rice, former head of the Stanford Research Institute's biomedicine division, to consult with the group on ways to cut development costs for early-stage biopharmaceuticals.

QB3 was particularly interested in developing and manufacturing therapies that target smaller diseases and therefore might not be attractive to deep-pocketed pharmaceutical companies.

Rice had founded Bridge Laboratories, which has facilities in the United States and China that provide chemistry services for drug-discovery companies. Outsourcing pieces of drug discovery has become a common cost-cutting measure in the biotechnology industry.

China was a logical collaborator for QB3's mission, Rice said. The Chinese government was interested in building what would be its first biologics manufacturing plant in a new science park in Taizhou. The area, about a 2½-hour drive northwest of Shanghai, is China's largest center for pharmaceutical production.

The Food and Drug Administration, recognizing the wave of drug-development outsourcing to Asia, is establishing an office in Shanghai to help guide the growing number of facilities on how to become compliant with its standards.

Beyond the labor benefits, Rice thought the new plant might offer cost savings by implementing a disposable “Wave” technology developed by General Electric, named for its use of a rocking motion that causes material in 1,000-liter plastic vessels to roll like the Pacific on a stormy night.

Enter PacificGMP, which had been using the Wave technology.

“Glen and his team came down here and got excited about dedicating an entire facility to the Wave platform,” Pierce said.

“We started off as just giving him advice,” he said. “Then we thought maybe we could be a contractor and assist them as they merged this new enterprise. We decided to merge with them when we realized there could be so many synergies between us in San Diego and the new facility in Taizhou.”

The collaboration involving Pacific GMP, QB3 and the Chinese government, named Pacific Biopharma, was created as a hybrid China/U.S. business, which allows it to serve clients in both countries. PacificGMP is now the U.S.-based subsidiary of the international collaboration.

The U.S. company was founded with limited cash from a small collection of private investors, Pierce said. One of the reasons the Wave technology worked for the startup was that it did not require the same capital commitment as steel fermentation tanks.

And because the system does not require the same intensive cleaning, the company could fit more production runs into its schedule.

Small to moderate production jobs are all the company could handle in its San Diego facility. If a company needed a larger production run, such as the amount of a drug needed for a late-stage clinical trial, it went to a company with more capacity.

The China expansion erases those limitations.

“There aren't any major contract biologics manufacturing facilities in China right now, let alone disposable technologies, so we are ahead of the curve,” Pierce said.