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ShangPharma (NYSE: SHP) announced the opening of a new cGMP manufacturing facility in the Shanghai suburb of Fengxian. The plant will allow ShangPharma to support its clients through Phase II and Phase III trials. Previously, the CRO/CMO was limited to providing clients with product for early discovery and then GLP Toxicology testing and a Phase I trial.

ShangPharma completed an $87 million IPO on the New York Stock Exchange in October 2010 (see story). At the time, the company said it would use part of the proceeds to pay for the cGMP facility. The company is also building a 150,000 square-foot laboratory services building, similarly located in Fengxian, which will provide pharmaceutical development services. That facility is scheduled to come online later this year.

The Fengxian facility will be operated as a wholly owned subsidiary of the Company under the name of China Gateway Pharmaceutical Development Co. Ltd. Its services will include process research and development, formulation research and development, analytical method development and validation, and cGMP manufacturing of intermediates and APIs. ShangPharma said it will expand its offerings to include commercial manufacturing of FDA/EMEA-approved drugs if the demand develops.

The new facility will also offer analytic support services, including testing of raw materials, intermediates and final products. An independent quality assurance department will ensure that cGMP standards are upheld.

According to a company press release, the new 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 clean room suites rated at Class 100,000 for isolation, 10 kilo-labs suites for bothnon-cGMP and cGMP manufacturing as well as a large research and development laboratory for analytical, formulation and process development activities. In addition, there are separate buildings for utilities, materials management, warehouse storage and waste water treatment with room for further expansion to support commercial manufacturing activities.

ShangPharma is a holding company whose divisions include Shanghai ChemPartner Co. Ltd. and Shanghai ChemExplorer Co. Ltd. One of the largest CROs in China, it employs over 1600 research scientists. It was founded in 2003.

Disclosure: none.

Source: ShangPharma's New Manufacturing Facility to Support Clients Through Phase III Trials