REPROCELL signs agency agreement with Ajinomoto Group for the marketing and sales of StemFit Basic03 GMP

8 November 2021
Clinical Capabilities

Yokohama Japan, 8 November 2021: REPROCELL has signed a new agency agreement with Ajinomoto Group for the marketing and sale of StemFit Basic03 GMP and GMP compliant recombinant human bFGF. These clinical-grade products are suitable for cell culture workflows leading to therapeutic applications.

StemFit Basic 03 GMP will be offered to clients for the establishment and maintenance of their Master Cell Banks created via REPROCELL’s GMP iPSC Master Cell Bank service, which generates iPSC lines suitable for clinical and therapeutic use. These new product offerings will also support the company’s vast portfolio of cell culture technologies.

"One of the emerging areas of iPSC research is the generation of iPSC-derived cell therapies. We now offer services to generate GMP iPSC – Master Cell Banks compliant with the regulatory standards and guidelines of the FDA, EMA, and PMDA, using the latest RNA reprogramming technology.” said Daisuke Usui, Chief Operating Officer. “The StemFit Basic 03 GMP culture media, together with other StemFit products, will be a beneficial tool for the clients to support their clinical workflow and translational research, including those using REPROCELL’s services.”

REPROCELL’s GMP iPSC – Master Cell Bank generation service includes 3 key benefits.

  • Compliance with FDA, EMA and PMDA
  • Commercial license available
  • Vector-free and non-integral RNA reprogramming technology

To find out more, visit the REPROCELL website (https://www.reprocell.com/gmp-ipsc-master-cell-bank) or listen to Daisuke Usui discuss the key features of this service below.

 

product_gmp

Figure 1: StemFit Basic03 GMP is an animal-origin free, defined medium for human pluripotent stem cell culture. This medium is capable of reprogramming, maintaining, and differentiating human stem cells under feeder-free culture conditions. This product is manufactured under GMP guidelines in an ISO 13485 certified facility.

product_bfgf

Figure 2: bFGF is a member of the FGF family of cytokines and is involved in a wide range of biological processes including proliferation of many types of cells, neuron differentiation and maintenance of pluripotent state. bFGF is mainly used for stem cell cultivation to expand pluripotent stem cells or mesenchymal stem cells. Human bFGF recombinant is a 17.1 kDa, containing 154 amino acid residues.


About StemFit: StemFit® is a range of xeno-free, chemically defined media proven to effectively maintain induced pluripotent stem cells (iPSCs) and embryonic stem cells (ESCs) under feeder-free conditions during the reprogramming, expansion, and differentiation. Available in research and clinical grade formulations, StemFit® combines market-leading colony forming efficiency with lower than standard media volume consumption to offer the cost-effective colony expansion.

About REPROCELL: REPROCELL's portfolio includes an extensive product and service offerings to support stem cell and drug discovery research. Their commercial biorepository of ethically sourced human tissues and extensive clinical networks enables their contract research services in human ex vivo living tissues, 3D bioengineered tissues, and iPSC generation and differentiation for both research and clinical applications.

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