ShangPharma Corporation a China-based pharmaceutical and
biotechnology research and development outsourcing company, has commenced
operations on the initial phase of production at the company’s Fengxian
facility. This new multi-purpose pharmaceutical development and cGMP
manufacturing facility is located in Fengxian in the suburbs of Shanghai, China.
The state-of-the-art facility will operate as a wholly owned subsidiary of the company
under the name of China Gateway Pharmaceutical Development Co. Ltd., and will
allow the Company to expand its service offering to process research and
development, formulation research and development, analytical method
development and validation, and cGMP manufacturing of intermediates and APIs.
This project represents ShangPharma’s growing capabilities
in cGMP manufacturing. To date, ShangPharma has successfully developed client projects
from the early discovery phase to the provision of materials for GLP Toxicology
and Phase I Clinical trials. With the newly added capacity in the Fengxian
plant, the Company will be able to support its clients’ projects all the way
through Phase II and into Phase III development, depending on scale. The
Company may further expand its manufacturing facilities if it experiences
strong demand for commercial manufacturing of FDA- or EMEA-approved drugs.
The Fengxian 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.
Part
of the new facility is dedicated to analytical support. Testing of raw
materials, intermediates and final products will be carried out at the site. An
independent quality assurance department ensures that materials are
manufactured in accordance with cGMP requirements and that established
standard operating procedures are followed.
