Polyplus, an upstream solutions provider for advanced biologic and cell and gene therapy production from research to commercial grade, has confirmed a successful audit and GMP accreditation from the Belgian federal agency for medicines and health product (FAMHP – l’AFMPS l’agence fédérale des medicaments et produits de santé) for GMP grade plasmid DNA production at the Xpress Biologics Milmort facility. The team is now able to scale plasmid DNA production for CGT applications, DNA vaccine development and mRNA synthesis from preclinical development through to GMP commercial manufacturing phases.

Polyplus completed the acquisition of Belgium’s Xpress Biologics, a contract service organization (CSO) and developer of expression systems for protein and plasmid DNA, at the end of 2022. Xpress Biologics DNA manufacturing process is based on a proprietary DNA extraction method allowing the same process to be used for many types of DNA plasmids used in DNA vaccine, CGT and mRNA manufacturing applications. The plasmid specifications, in terms of purity, are the same for RUO, HQ and GMP grade plasmids.

“The audits of our facility were performed from December 15-16 in 2022 and GMP accreditation was awarded on 26 January 2023 (EudraGMP certificate number BE/GMP/2022/098),” said Xpress Biologics general manager, Marc Daukandt. “This is great progress for our team and our customers, and we will continue to expand the breadth and scale of our service solutions. The next step will be accreditation for the manufacturing of GMP grade recombinant proteins, expected in Q3 of this year.”

Mario Philips, CEO, Polyplus, said, “This accreditation expands the Polyplus upstream process economics solutions portfolio following our strategy of delivering scalable products and services for development to preclinical and clinical stages into commercial manufacturing. With this new accreditation, Polyplus now feature a full range of vector design, plasmid DNA manufacturing, transfection reagents (for life sciences, non-viral, protein and CGT applications), process development and CGT fill and finish services.”

5 GMP batches are already under manufacturing, and GMP manufacturing slots are available for new projects as early as April 2023.