WuXi AppTec expands commercial manufacturing capabilities
WuXi AppTec, a global pharma, biotech and medical device r&d outsourcing company with operations in China and the US, has commenced validation at its new 350,000ft2 commercial manufacturing plant plant on its site at Jinshan, near Shanghai.
WuXi AppTec, a global pharma, biotech and medical device r&d outsourcing company with operations in China and the US, has commenced validation at its new 350,000ft2 commercial manufacturing plant plant on its site at Jinshan, near Shanghai.
The new plant will quadruple the manufacturing capacity at the site, which also includes a 220,000ft2 cGMP-quality process development and manufacturing plant. The new multipurpose plant is projected to have an annual capacity of 50-100 tonnes and features 18 reactors with capacities from 8,000 – 20,000 litres. It also has cryogenic capacity down to –78°C at 10,000 litre scale and high temperature capabilities up to 300°C.
There are two isolated Class 100,000 API finishing areas, GMP kilo labs and high pressure reaction capability.
‘We built the commercial GMP facility to further integrate our manufacturing services from pilot scale to large scale to commercial scale,’ said Dr Suhan Tang, chief manufacturing officer. ’By having all the capabilities at the same site, our customers will avoid the need for any technology transfer between different sites. As a result, development timelines will be shortened.’
WuXi AppTec has also launched its Global Procurement Service (GPS) to assist its customers to purchase low-cost commercial reagents from qualified vendors in China. Through GPS the company will not only help to purchase the reagents but will also assure their quality by providing complete QC testing and certificate of analysis. It can also offer repacking, relabelling and export services.