Polyplus ups protein and DNA capacity in Belgium

Xpress Biologics, a Polyplus company (owned by Sartorius since March 2023), renewed its GMP certification for DNA production and gained authorization for recombinant protein production at its Milmort, Belgium plant.  Additionally, the firm said it has added a clean room for the manufacture of cell banks and plans to bolster capacity through a planned production line at the site.

“The new GMP production line will include a 100 L bioreactor. This investment is needed for the production of GMP DNA commercial batches requiring a higher bioreactor scale than the one currently possible at Xpress Biologics level. On top of that, the protein projects also require a higher scale,” Frank Backers, CFO of Xpress Biologics told BioProcess Insider.

“That is also a necessary argument to attract major market players with whom discussions about the production of GMP DNA commercial batches have been initiated.”

No specific financial of what the production line will cost Xpress Biologics has been disclosed. However, Backer said “the investment still needs to be approved by Sartorius, but the plan is to have it up and running by Q2 2025.” Additionally, the firm anticipates the new production line to create sales over €50 million ($54.6 million) across a seven-year period “with an ultimate increase of our gross margin by 5%.”

The Belgium Federal Agency of Medicines and Health Products (FAMHP) awarded Xpress Biologics with the new GMP certification for protein production. This includes the manufacture of antibody fragment using microbial expression systems such as P. pastoris and E. coli, as well as recombinant proteins.

“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 plasmid DNA (pDNA) batches and Master Cell banks for different cell and gene therapy (CGT) and messenger RNA (mRNA) vaccine applications,” said Marc Daukandt, general manager 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.”