New firm spruiks S Korea as manufacturing hub

Founded as a joint venture between Californian AIDS vaccine company VaxGen and South Korean investors, manufacturing company Celltrion is being developed to provide large-scale mammalian cell culture manufacturing for the biopharmaceutical industry.

When completed in 2004, the manufacturing facility -- which is being built in Incheon, South Korea -- will have an initial capacity of 50,000 litres, with projected expansion to 150,000 litres down the line. The facility is slated to begin commercial production in 2005. In addition, a smaller, pilot facility with a 1000 litre fermentor has been built at VaxGen's South San Francisco site for use in smaller-scale manufacturing activities, process development and training.

But why build such a large manufacturing plant in South Korea? According to Dr Seung-Il Shin, senior advisor for international development at parent company VaxGen, and Celltrion board member, the venture developed out of a potential need to manufacture large quantities of VaxGen's HIV vaccines. To date, VaxGen has used facilities at Genentech, where the company's technology initially originated, to manufacture material used in its clinical trials.

"But we realised we had no large-scale facility to manufacture the vaccine if it worked," Shin told Australian Biotechnology News. After talks with contract manufacturers, VaxGen eventually decided it would have to build its own facility, and secured a US$120 million deal with Korean investors to set up Celltrion. Korean partners in the company include Nexol Corporation, Nexol Biotech Corporation, KT&G Corporation, and J Stephen & Co Ventures.

"We thought that eventually [the plant] had to be in a place where we could make products more economically," Shin said.

And the manufacturing company has put together a talented team to develop the new facility, with former Genentech's senior VP of product operations, James Panek, as chairman and co-CEO alongside Nexol's Jung-Jin Seo.

While VaxGen's HIV vaccine has not shown sufficient protection in the study population of the multi-national Phase III clinical trial, a second Phase III trial in Thailand is still ongoing and results are expected later this year. In the meantime, however, Celltrion is looking at developing partnerships with other biopharmaceutical companies to manufacture products for clinical trials and beyond.

"We have been searching for potential partners who need large-scale technology and also partners who require clinical grade material on a contract basis," said Shin.

With the pilot facility soon to be up and running, Celltrion is now looking for commercial clients. Shin said the first clinical product to be made in the pilot facility, which is capable of more than mammalian cell culture, is likely to be an anthrax recombinant vaccine for the US government, one of several biodefence projects VaxGen has taken on, and the company expects to make the first batch later this year.

The pilot facility will also act as a training facility for operators to go into the Korean facility, with the eventual ability to move projects smoothly from small-scale development and manufacturing in the US to large scale manufacturing in Korea.