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Taipei Taiwan, Osaka Japan –28th August 2025
TFBS Bioscience Inc., a Taiwan and Japan-based company offering total solutions for GMP manufacturing of viral vector and U-Medico Inc., a leading Japanese company providing advanced analytical solutions, today announced a strategic partnership to jointly launch a new suite of Good Manufacturing Practice (GMP) Quality Control (QC) testing services. This collaboration marks a significant milestone in international cooperation, aiming at delivering accurate, regulatory-compliant QC testing services for viral vectors across Japan, Taiwan, and the broader Asia-Pacific region.
The partnership will initially focus on quality testing for viral vectors, such as adeno-associated virus (AAV), which are essential components in gene therapy. As the alliance progresses, the service scope will gradually expand to cell therapies, biologics, and other advanced therapeutics, addressing the rising demand for high-resolution and high-efficiency QC services in the fast-growing CGT sector.
U-Medico is renowned for its analytical technologies and state-of-the-art instrumentation, offering a competitive edge in structural and purity analysis of biopharmaceuticals. Its proprietary Analytical Ultracentrifugation (AUC) technique enables precise measurement of full and empty AAV particles — a critical quality attribute impacting both product safety and efficacy. In addition, Mass Photometry technology enables rapid quantification of viral particles and protein aggregates with minimal sample volume, making it ideal for early development stages or limited materials.
Complementarily, TFBS Bioscience brings in its expertise in biology-based method development in vitro and in vivo, offering a broad spectrum of services including cell bank characterization, viral clearance studies, and biological safety testing. TFBS also operates a GMP CDMO facility, capable of manufacturing various viral vectors, including AAV, lentivirus, retrovirus, and adenovirus. To emphasize the idea from concept to commercial product, TFBS provides an integrated "testing-to-manufacturing" solution, including cell and virus banking, plasmid production, viral vector manufacturing, assay development, pharmacology, and toxicology studies.
According to both companies, the value of this alliance lies in its integration of TFBS Bioscience’s biology-based expertise and U-Medico’s instrumentation-based capability , enabling clients to access a one-stop QC solution to achieve the regulatory requirement in a timely and effective manner and facilitate regulatory submissions in key markets such as Japan PMDA, US FDA, and Taiwan TFDA.
This strategic partnership also reflects the importance of increasing regulatory demand and harmonization for the developing CGT field in different countries. TFBS Bioscience and U-Medico aim to establish a center of excellence for QC testing in Asia, helping innovative therapies reach patients faster with greater safety and quality assurance.
About TFBS Bioscience Inc.
TFBS Bioscience Inc. (TFBS) was founded in 2016 as the first contract research organization providing GLP biological testing in Taiwan. TFBS has established strong track records in regulatory submissions, winning trust from the international regulatory agencies and biopharmaceutical industry. TFBS has launched the first viral vector contract development and manufacturing facility in Taiwan, providing fully integrated end-to-end contract development and manufacturing services for various viral vectors, including adeno-associated virus, lentivirus, and retrovirus. With the customization specialty and state-of-the-art facility, TFBS is the best partner offering clients a one-stop-shop solution for gene and cell therapy from clinical trials to commercial production. For more information, please visit www.tfbsbio.com.
About U-medico Inc.
U-Medico Inc. is a contract research organization established in 2006 as a spin-off from Osaka University, specializing in analytical and formulation development services for biopharmaceuticals and gene therapeutics. The company provides cutting-edge biophysical characterization technologies such as analytical ultracentrifugation (AUC), hydrogen-deuterium exchange mass spectrometry (HDX-MS), and aggregate analysis. U-Medico serves over 40 domestic and international clients annually and has supported numerous drug development and manufacturing projects. In 2022, U-Medico expanded into gene therapy analytics, and in 2024, it is launching manufacturing services for viral vectors, supporting the stable development of gene therapy products. For more information, please visit www.u-medico.co.jp.