WuXi Biologics announced that the European Medicines Agency (EMA) had completed its pre-approval inspection of the company’s drug substance and drug product manufacturing facilities for the production of Trogarzo (ibalizumab).
The contract development and manufacturing (CDMO) stated that the EMA did not find any ‘critical findings’ and therefore would expect to receive good manufacturing practice (GMP) certification in May 2019.
A spokesperson for WuXi Biologics told us, “Globally, there is only a handful of CDMOs that are EU approved, so it is very significant. Certainly, we [would be] the first in China.”
Before receiving formal approval, the Chinese company stated that it would have to submit responses to the EMA inspection next month. The spokesperson was not able to outline exactly what these would address but noted, “Some improvement in our procedures is needed.”
The same WuXi Biologics facilities being inspected by the EMA were given US Food and Drug Administration approval in March 2018 to produce the drug substance and the finished drug product for TaiMed Biologics’ Trograzo, an HIV treatment.
Global expansion
European approval for the CDMO’s facilities would mark another stage in WuXi Biologics’ global expansion. The company has made significant moves within its own country to expand capacity, such as with the expansion of ‘WuXi City’, but has also invested in building its presence in Ireland and Singapore.
The spokesperson told us that this global build-out, across China, Ireland, Singapore, and the US, is with the aim of reaching a 220,000 litres capacity within its supply chain network by 2021.
