Wuxi Griffin Pharmaceutical Co. Ltd. is a new China-based company that has begun operations as an international contract manufacturer of sterile fill/finish pharmaceuticals. It is a Western managed joint venture between Sweden and China. According to the company, the focus will be to provide sterile fill and finish manufacturing services that meet Western GMP standards.

When discussing biologics in the Chinese market, Torgny Lundgren, chief executive officer of Wuxi Griffin Pharmaceutical, says very few Western contract manufacturers have established their presence in the Chinese market, especially to Western quality standards.

“There has been a lack of know-how of how to implement Western manufacturing GMP standards in China and this gap is filled by the new plant in Wuxi, China,” he said. “At a time when several biologics are coming off patent, the opportunities to be seized are significant as these pharmaceuticals will become more accessible in areas where it was previously not considered.”

China is the second largest market for pharmaceuticals and with the highest growth rate, Western pharmaceutical companies are looking to China to expand.

Products manufactured in the new Wuxi facility include MAbs, vaccines, recombinant proteins as well as biosimilars and traditional small molecule drugs. RABS and isolator production technology is used. There is capacity for manufacturing of clinical trials materials for biologics—small and medium-sized batches—as well as commercial manufacturing.

“Complying to global GMP standards gives us an advantage as the requirements of Chinese customers wanting Western quality products are met,” said Mr. Lundgren. “We also assist Western pharmaceutical companies wanting accelerated access to the Chinese market.”