Collaboration provides end-to-end coverage of mRNA drug and vaccine development and manufacturing workflow
HOUSTON, TX and NEEDHAM, MA – PackGene Biotech (PackGene) and Kudo Biotechnology (Kudo Bio) have partnered to provide high-quality, customized 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 organization (CRO) and contract development and manufacturing organization (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 prioritize 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.
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) laboratories to optimize 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 authorization 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 customized 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.”
About PackGene Biotech
PackGene Biotech is a leading CDMO that specializes in the production of plasmid DNA for mRNA production. Their GMP plasmid production site, located in Guangzhou, China, is dedicated to providing reliable, compliant, and scalable plasmid production services. With its reliability, scalability, and compliance, PackGene’s facility provides high-quality plasmid production services that exceed industry standards and a specialized process for mRNA IVT templates.
PackGene is renowned for its proprietary π-Alpha™ 293 AAV High-Yield Platform, a triple-plasmid transfection system that uses uniquely designed RC plasmid to increase AAV production by three to eight times in various AAV serotypes. PackGene provides economical, reliable, and scalable plasmid DNA and AAV viral vector production for early-stage drug discovery, preclinical development, and clinical trials for Cell and Gene Therapy (CGT). For more information, please visit www.packgene.com.
About Kudo Biotechnology
Kudo Biotechnology is a leading global mRNA CDMO, providing world-class, end-to-end mRNA manufacturing solutions, all under one roof. Kudo Bio has a state-of-the-art clinical GMP manufacturing facility and MSAT laboratories in Shanghai, with additional presence in Boston and Singapore. Their GMP manufacturing facility spans over 57,000 sqf and is designed in accordance with cGMP and global regulatory guidelines, featuring 2 plasmid lines, 3 mRNA lines, 2 LNP bulk lines, and 1 drug product fill & finish line. Kudo Bio’s production lines cater to manufacturing needs for preclinical through Phase 2 clinical trials, with the capacity to manufacture up to 40 million vials/year for Phase 3 and commercial manufacturing. Their cutting-edge equipment is customized for mRNA and LNP drug development, and they offer a range of additional services, including Process and Analytical Development, Technology Transfer, Fill & Finish, Testing & Release, and Supply Chain Management.
Kudo Bio provides comprehensive solutions for their clients’ drug development needs, and has a robust QMS to ensure the highest quality and to comply with global regulations. Kudo Bio is expanding its presence in the United States, with a process development laboratory currently under construction in Needham, MA. For more information, please visit www.kudobio.com.
Irene Song, PhD
Sr. Director, Global Product
Kelvin Chan, PhD
Director, Business Development
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