Xpress Biologics, a Polyplus (part of Sartorius) company, received GMP certification for recombinant protein production and renewed the January 2023 GMP certification for DNA production at the facility in Belgium. In parallel to the new certification, an additional GMP clean room for the production of GMP cell banks has been added and the addition of a GMP production line is planned at the Belgium facility to increase capacity.
“These certifications and extra capacity enable our Xpress Biologics team to offer research and development into clinical phase support for any type of protein or DNA project, which can be hard to find,” said Mario Philips, head of Polyplus.
The new GMP certification for protein manufacturing covers the production of recombinant proteins including antibody fragments using microbial expression systems like E. coli and P. pastoris.
“We have already made great progress in just a year working with the DNA GMP certification. So far we have completed GMP release of 13 pDNA batches and Master Cell banks for different cell and gene therapy (CGT) and mRNA vaccine applications,” noted Marc Daukandt, chief business officer of Xpress Biologics. “It is exciting to see our plans continue to unfold and how positively this impacts our customers, and ultimately patients. We expect to have similar progress with the new protein GMP manufacturing services now that it is ready to go.”
