ShangPharma has opened a multi-purpose pharmaceutical development cGMP manufacturing facility in Fengxian, China, and started operations on the initial phase of production.
The pharma and biopharma research and development (R&D) outsourcing company, said its state-of-the-art facility will be named China Gateway Pharmaceutical Development Company and will operate as a wholly owned subsidiary of the firm.
The expansion will enable ShangPharma to boost its service offerings in process and formulation R&D, analytical method development and validation and current good manufacturing practice (cGMP) manufacturing of drug intermediates and active pharmaceutical ingredients (APIs) for preclinical development and clinical trials.
A ShangPharma spokesperson said: “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.”
The contract research organisation (CRO) added that further plans may be made to expand the manufacturing facilities to 460,000 sq ft if it experiences a strong demand for commercial manufacturing of FDA – or EMEA – approved drugs.
Last year, ShangPharma raised $87m (€65m) through an IPO on the New York Stock Exchange, of which the firm planned to spend $15m on the new Fengxian site.
Some of these proceeds have been spent on equipping the Fengxian facility with a pilot plant boasting six separate bays with reactor capacities of 200 to 3,000 litres, as well as other specialty bays for high temperature, cryogenics, and highly toxic and pressurized reactions such as hydrogenation.
Clean room suites and R&D lab
Additionally, ShangPharma said there are two clean room suites rated at class 100,000 for isolation, 10 kilo-lab suites for non-cGMP and cGMP manufacturing, alongside an R&D laboratory for analytical, formulation and process development activities.
According to the China-based firm, there is an area of the new facility dedicated to analytical support, and testing of raw materials, intermediates and final products will also be carried out at the site.
A separate quality assurance (QA) department has been added to allow the company to ensure materials are manufactured to keep in line with standards set out by cGMP guidelines.