Kudo Biotechnology (Kudo Bio) and PackGene Biotech (PackGene) have partnered to provide high-quality, customised messenger RNA (mRNA) manufacturing services for drug and vaccine development.
The global collaboration provides end-to-end coverage of 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.
PackGene, a contract research organisation (CRO) and contract development and manufacturing organisation (CDMO), has expanded its services to support mRNA drug development. By partnering with Kudo Bio, an mRNA and LNP CDMO, both companies aim to provide custom mRNA GMP manufacturing with industry-leading timelines, superior quality, stellar performance, and comprehensive analytical panels in a streamlined manner.
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.
The collaboration offers a one-stop platform for mRNA and LNP production, including pDNA production and cell banking, mRNA synthesis, LNP encapsulation and formulation development, GMP batch release and certificates of analysis, fill and finish, and investigational new drug (IND) filing assistance. PackGene and Kudo Bio both highly prioritise regulatory compliance and offer a quality management system that meets global regulatory standards.
"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.
We offer a streamlined process to ensure efficiency and reliability in CMC while delivering superior quality that exceeds the highest global industry standards
- Molly S. McGlaughlin, CEO of Kudo Bio
Customised process and analytical development for DNA templates, mRNA drug substances, and drug products is performed at the companies’ Manufacturing Sciences and Analytical Technology (MSAT) laboratories to optimise each project's potential. The extensive analytical panel for pDNA, mRNA, and LNP provides valuable insights that allow for bespoke in-process control, release testing, and stability studies.
The rigorous quality control processes ensure that products meet and exceed the highest global standards, comparable to renowned CDMOs. Kudo Bio assists clients with mRNA development and production, with a client notably receiving clinical trial authorisation of one of its GMP mRNA products by both HSA Singapore and TGA Australia.
"The collaboration between PackGene Biotech and Kudo Biotechnology will help to meet the growing demand for customised mRNA and LNP production services," said Molly S. 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."
