ShangPharma Corp. began operations on the initial phase of production at its new pharmaceutical development and cGMP manufacturing facility in Fengxian, China. The facility, a wholly owned subsidiary of ShangPharma, will operate as China Gateway Pharmaceutical Development Co. Ltd., and will allow the company to expand its service offering to include process R&D, formulation R&D, analytical method development and validation, and cGMP manufacturing of intermediates and APIs.

With the newly added capacity, the company will be able to support projects through Phase II and into Phase III, and can further expand its manufacturing facilities based on demand for commercial manufacturing of FDA- or EMEA-approved drugs.

The facility includes a pilot plant that has six separate bays with reactor capacities ranging from 200 to 3,000 liters and other specialty bays with reactor capacities ranging from 50 to 2000 liters for high temperature, cryogenics, highly toxic and pressurized reactions, including hydrogenation. There are also two cleanroom suites rated at Class 100,000 for isolation, 10 kilo-labs suites for both non-cGMP and cGMP manufacturing, as well as a large R&D lab for analytical, formulation and process development activities. Part of the new facility is dedicated to analytical support, and testing of raw materials, intermediates and final products will also be carried out at the site.