Takara Bio offers comprehensive and seamless manufacturing and quality-testing services for cellular and gene therapy products.

• CMO services include viral vector production, T-cell processing, human embryonic stem (hES) cell line derivation, quality testing, and cell banking
• State-of-the-art GMP manufacturing sites in Japan and Europe enable the production of safe, dependable products under stringent manufacturing conditions
• Expert assistance on navigating regulations and custom industrial applications simplifies the workflow and provides peace of mind from start to finish

For over 20 years, Takara Bio has developed novel products with important gene therapy applications. In 1995, Takara Bio and Indiana University developed the RetroNectin method, which involves using a plate-coating substance to increase the physical interactions of cells and viruses, greatly increasing transduction efficiency.

Since that time, we have developed additional ways of using the RetroNectin method and viral vector technology for new therapeutic applications, such as in boosting naïve-like T-cell expansion for CAR-T therapy. RetroNectin reagent, now available as a GMP-grade version, has been used in over 60 clinical studies around the world.

Clinical trials for gene therapy projects

Products manufactured by Takara Bio but developed independently by various organizations, as well as products jointly developed with and manufactured by Takara Bio, are being tested in ongoing clinical trials, with the goals of steady progress and commercialization in the near future. To find out more about Takara Bio’s clinical trials, click here.

Long history as a research reagent supplier

Since 1979, Takara Bio has been continuously developing molecular and cellular research reagents for the life science research community. Now, we offer a unique combination of GMP-grade products and gene analysis services to meet your manufacturing and quality-control needs.

GMP-grade products

Our T-cell immunotherapy products are well-integrated into our T-cell immunotherapy manufacturing service. RetroNectin reagent, a recombinant human fibronectin fragment, is widely used to enhance lentiviral- and retroviral-mediated gene transduction. To meet the clinical research community's needs for a reagent suitable for ex vivo clinical applications, we developed RetroNectin GMP Grade. As T-cell expansion for clinical applications requires additional products, we have expanded our product line to include GMP-grade anti-CD3 monoclonal antibody, T-cell culture media (research grade), and CultiLife culture bags.

Takara Bio also offers GMP-grade stem cell research products. Cellartis DEF-CS 500 Xeno-Free GMP Grade Basal Medium is a proprietary human pluripotent stem cell maintenance medium that complies with the highest conditions of stringency, and is completely free of all animal and human components to avoid introducing any pathogens or immunogens to patients.

Gene analysis services

Leveraging our extensive gene analysis techniques and expertise, Takara Bio provides contract research services for gene analysis. We provide advanced genetic engineering research support services and equipment used in techniques such as next-generation sequencing and genome editing. Takara Bio is certified by the College of American Pathologists’ Laboratory Accreditation Program (CAP-LAP) for Molecular Pathology, Next Generation Sequencing.

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