Strasbourg, France, 6 February 2024 – Xpress Biologics, a good manufacturing practice (GMP) certification for recombinant protein production, and renewed the January 2023 GMP certification for DNA production at the facility located 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.
“This is a great time at Polyplus, as we continue to grow our footprint and capabilities under the Sartorius umbrella, fulfilling promises made to support customers. These certifications and extra capacity enable our Xpress Biologics team to offer research and development (R&D) into clinical phase support for any type of protein or DNA project, which can be hard to find,” said Mario Phillips, Head of Polyplus. “The time and financial investment also reflect our commitment to filling gaps for customers with reliable, scalable products and support—a vision all our team shares.”
The new GMP certification for protein manufacturing covers the production of recombinant proteins including antibody fragment using microbial expression systems like E. coli and P. pastoris under certification number BE/GMP/2023/093 and MIA 2100 IMP. The certification was performed by the Belgian Federal Agency of Medicines and Health Products (FAMHP) and is recognized by the FDA and EMA for recombinant plasmid and protein manufacturing including antibody fragments.
“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,” 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.”
Integration efforts across the companies continues in 2024, with a focus on ensuring ease of service and support for customers. Further developments will be available throughout the year, or by visiting: www.polyplus-sartorius.com/.
About Polyplus
Polyplus, part of Sartorius, is a leading upstream solutions provider for advanced biologic and cell and gene therapy production from research to commercial scale. The legacy nucleic acid delivery portfolio features process-centric transfection reagents, kits, and support services including bioproduction industry standard, PEIpro® and FectoVIR®-AAV. In 2020, the company began focusing on upstream bioprocess economic optimization with the addition of custom plasmid vector design, GMP transfection reagent and plasmid manufacturing with an internalized supply chain designed to meet strict scientific and regulatory standards. Headquartered in Europe, the Polyplus team continues to grow globally with operations in the United States and Asia.
Xpress Biologics is an established Belgian microbial CDMO acquired by Polyplus in 2022 and providing R&D to GMP grade plasmid and protein manufacturing services.
Media Contact Information:
Géraldine Guérin-Peyrou
Marketing and Communication Director at Polyplus
marketing@polyplus-transfection.com