ABEC has received approval to supply bioprocessing equipment to China from its facility in Kells, Ireland.
Bioreactor and bioproduction equipment vendor ABEC has been supplying the Chinese market for the best part of a decade, after its Springfield, Missouri facility obtained a China Manufacture License (CML) in 2010.
Now the firm can supply its tech from a second facility, the Kells plant in County Meath, Ireland, after the government granted the plant a China Manufacture License (CML) to manufacture pressure vessels and components for use in the country.
The Kells plant manufactures pressure vessels, skidded process equipment, and container holders for ABEC’s Custom Single Run (CSR) single use product line.
“[The CML] helps the People’s Republic of China government ensure that pressurized equipment coming to China is safe to use,” ABEC spokesperson Susan Cooper-Curcio told BioProcess Insider. “There is a process to follow and a rigorous audit of vessel engineering, manufacturing and quality processes by the China Special Equipment Inspection & Research Institute (CSEI).”
Any facility that makes pressure vessels intended for China needs a CML, even if it is part of the same company. ABEC is the only systems supplier to boast licenses on two continents, she added.
“ABEC has vessel design and manufacturing in-house, so has full control of these critical components. Many other equipment firms outsource them, which we believe adds risk to quality, cost, and schedule.”
For ABEC, demand from the Chinese market is currently on the up.
“Proportions for the different regions around the world generally change year on year, but currently we do see particularly high growth in the China market,” said Cooper-Curcio.
Earlier this year, the firm won a contract to equip contract development and manufacturing organization (CDMO) WuXi Biologics’ commercial manufacturing facility in Wuxi city, Jiangsu, with its 4,000 L CSR disposable bioreactors.
WuXi’s CEO Chris Chen said at the time: “ABEC’s large volume single-use bioreactor greatly enhances our commercial manufacturing potential by allowing not only scale-out of capacity but also scale-up. In addition to the flexibility and time to market benefits of single-use manufacturing, we can now offer our clients true economies of scale and address biologics supply needs from kilograms to tons.”