(Taiwan) DCB's biopharm contract manufacturing facility obtains cGMP and FDA certification :: BiotechEast - Taiwan and China biotechnology, medical devices, pharmaceuticals, ^¤å½s×, ^¤å×§ï ::

(David Silver, BiotechEast)

21 January, 2006
Taiwan's Development Center for Biotechnology (DCB) announced last week that its new Biopharm Pilot Plant, a biopharmaceutical contract manufacturing facility, had received cGMP and FDA certification. With its 300 and 500 liter bioreactors now up and running, the DCB can boast having the largest facility of its kind in Taiwan.

Director of the Development Center for Biotechnology, Dr. Juilien Huang, at a ceremony in Taipei announcing that the center's Biopharm Pilot Plant had receiving cGMP certification.

At a ceremony on Wednesday marking the announcement at the its Xizhi facilities in Taipei County, the director of the DCB Dr. Juilien Huang predicted that the plant would provide a much-anticipated boost for the island's biotech sector, bringing online contract manufacturing and research capabilities that have up to now been unavailable to local companies.

Huang explained that with its new manufacturing plant together with its onsite toxicology facility and research labs focusing on contract (as well as its own) drug discovery and development research, the DCB is now fully set up to provide a complete range of services to the island's drug discovery industry.

While other local companies provide contract manufacturing facilities, for example Mycenax Biotech, UBI Asia, and Advanced Gene Technology, the DCB's range of reactors at both its research lab (up to 100 liter) and manufacturing plant (100, 300 and 500 liter) are the industry's most extensive and provide the largest capacity tanks in use in Taiwan.

Discussing the DCB's role in helping develop the local biotech industry, Huang lamented the fact that many had been skeptical of the future of Taiwan's drug discovery and development sector, currently numbering around 15-20 relatively small-sized companies.

"However, even [the world's two largest biotech companies] Genentech and Amgen, when they first started out, had to collaborate with bigger companies before they became famous. So Taiwan's companies, although small, still have potential to become successful. They have to start somewhere," she said, implying that smaller companies could now let the DCB take over early stage manufacturing requirements for them, leaving them better focused on their core competancies.

Dr. Chi Wei-kuang, director of the pilot plant, said that the DCB was planning to look beyond Taiwan's shores for customers.

"We hope to promote Taiwan's capabilities in bioreactors to international customers, particularly in the US and Europe," he said.

To meet the demands of such international clients, the plant was designed from the ground up by specialist bio-facility design and compliancy companies Bio-Pharm Technologies, Day & Zimmermann International Inc, and Don Hill Associates, FDA consultants.

The DCB Biopharm Pilot Plant's 500 liter bioreactor.

The cost of setting up the lab and all the associated equipment was NT$380 million (around US$11 million), a figure not including the substantial additional costs involved in getting the plant certified to cGMP standard post-construction, said Chi.

Chi mentioned that the 300 liter plant passed cGMP certification in December of last year, with the 500 liter plant expected to pass certification soon.

The whole facility, including reactors, research labs and factory control areas employ around 40 scientists and technicians, out of the DCB's total staff of over 400.

The DCB is an autonomous, non-profit research and development organization partially supported by Taiwan's government on a contract basis. Established in 1984, its purpose is to promote and upgrade the life science industries in Taiwan, defined locally as including the biotech, pharmaceutical, herbal medicine and medical device industries. According to its website, by linking with government, academic, and industrial sectors, the DCB develops key technologies, builds bio-infrastructure, and trains industry professionals.

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