For pharma development and cGMP manufacturing
ShangPharma Corporation, a China-based contract research and manufacturing organisation, has started operations at a new manufacturing facility in the Shanghai suburb of Fengxian.
The new multi-purpose pharmaceutical development and cGMP manufacturing facility will allow ShangPharma to support its clients Phase II and Phase III trials, expanding its service offering to include process and formulation r&d, analytical method development and validation, and cGMP manufacturing of intermediates and APIs.
Previously the CRO/CMO provided clients with materials for early discovery and GLP toxicology testing and Phase I clinical trials.
ShangPharma said it might further expand its manufacturing facilities if there is demand for commercial manufacturing of FDA- or EMEA-approved drugs.
The Fengxian facility will operate as a wholly owned subsidiary of the company under the name China Gateway Pharmaceutical Development Co. It includes a pilot plant that supports six separate bays with reactor capacities ranging from 200 to 3,000 litres and other speciality bays with reactor capacities ranging from 50 to 2000 litres for high temperature, cryogenics, highly toxic and pressurised reactions, including hydrogenation.
The company said there are also two cleanroom suites rated at Class 100,000 for isolation, 10 kilo-lab suites for bothnon-cGMP and cGMP manufacturing, as well as a large r&d 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.
Testing of raw materials, intermediates and final products will be carried out at the site. An independent quality assurance department will ensure that materials are manufactured in accordance with cGMP requirements and that established standard operating procedures are followed, the firm said.