PackGene BioTech, a CDMO that specializes in the production of plasmid DNA for mRNA production, and Kudo Biotechnology, a global mRNA CDMO, joined forces to provide customized messenger RNA (mRNA) manufacturing services for drug and vaccine development. The global collaboration provides mRNA development, from gene to mRNA, lipid nanoparticle (LNP) formulation development and encapsulation, through to fill-finished drug product, under good manufacturing practice (GMP) guidelines.

Under terms of the partnership, PackGene will provide process development and manufacturing services for plasmid DNA (pDNA) and cell banking, and Kudo Bio will provide process development, analytical development, and manufacturing of mRNA and LNP, as well as fill and finish.

Customized process and analytical development for DNA templates, mRNA drug substances, and drug products is performed at the companies’ Manufacturing Sciences and Analytical Technology (MSAT) labs to optimize each project’s potential. The extensive analytical panel for pDNA, mRNA, and LNP provides insights that allow for custom in-process control, release testing, and stability studies.

“With our combined expertise in process and analytical development and GMP facilities operations, we offer our clients a seamless transition from development to manufacturing and access to unparalleled expertise, professionalism, and convenience in pDNA, mRNA, and LNP production,” said PackGene chief strategy officer, Xin Swanson.

“The collaboration between PackGene Biotech and Kudo Biotechnology will help to meet the growing demand for customized mRNA and LNP production services,” said Molly McGlaughlin, CEO of Kudo Bio. “By providing a one-stop solution across the entire workflow of mRNA drug and vaccine development, we offer a streamlined process to ensure efficiency and reliability in CMC while delivering superior quality that exceeds the highest global industry standards.”