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Clinical Capabilities

Clinical Grade Stem Cells

GMP iPSC - Master Cell Bank

Your partner in regenerative medicine development

Developing cellular therapies is a time-consuming and costly process. It requires strict adherence to manufacturing and regulatory standards that are different for each national regulatory agency. At REPROCELL, our scientists can manufacture GMP iPSC – Master Cell Bank compliant with the regulatory standards and guidelines of the FDA, EMA, and PMDA - granting you access to the largest markets.

With global access to human tissue samples, we can procure the tissues needed for your cell therapeutic, perform the necessary viral and donor profile screenings, and derive the primary fibroblast primary culture. Using footprint-free RNA reprogramming technology, our researchers can generate a clinical grade iPSC seed stock from these fibroblasts using GMP-grade media and reagents.

Following quality control, these seed iPSCs can be expanded in a GMP environment to form a master cell bank. The final GMP iPSC lines will be exclusive to you; available only for your therapeutic project.


 

Why choose REPROCELL?

  1. Compliant with FDA, EMA, PMDA
  2. Commercial licence avaible
  3. Milestone-based and customizable studies
  4. Vector-free RNA reprogramming
  5. Comprehensive, end-to-end clinical services

 

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Compliant with FDA, EMA, and PMDA

At REPROCELL, we manufacture GMP iPSC – Master Cell Banks compliant with the regulatory standards and guidelines of the FDA, EMA, and PMDA. By using our Master Cell Bank you not only gain access to the biggest markets globally, but your research will be compliant with regulatory standards from project beginning to end.

Our iPSC experts will provide the necessary quality and regulatory documents such as COA, batch records, and quality technical agreement for your GMP iPSC – Master Cell Bank.

07AUG20 fda regulatory approval pharmaceuticals-1

Commercial licence available 

Our clients often have questions about donor consent; all of our tissue donors have fully consented to the clinical and commercial use of their cells. Throughout the development of your GMP iPSC – Master Cell Bank, we will ensure that appropriate donor consent is in place.

We can also provide the necessary clinical and commercial licenses for your project – making us a hassle-free one-stop solution provider for your iPSC needs.

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Milestone-based and customizable 

Our projects are milestone-based, and fully customizable, meaning we can design a study to suit your research needs and budget. At the completion of seed iPSC generation, we can deliver the iPSC clones to you; meaning you can initiate your R&D program and optimize your differentiation protocol to identify the best clone for your project.

This same clone will be used for Master Cell Bank generation, negating additional re-optimization processes, and ensuring that the same iPSC clone will be used from preclinical research to commercialization.

07AUG20 GMP gfacility drug manufacturing pharmaceuticals-1

Vector-free RNA reprogramming 

At REPROCELL, our scientists will generate your clinical grade stem cells using sophisticated RNA reprogramming technology. This footprint-free reprogramming technique allows you access to the consistency, safety, and quality needed for demanding therapeutic projects.

RNA reprogramming is ideal for therapeutic projects because it generates iPSCs that do not contain viruses or vectors that could interfere with subsequent differentiation.

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Comprehensive clinical services 

REPROCELL was the first company to successfully commercialize iPSC derived cardiomyocytes and hepatocytes and has been a leader in stem cell research ever since. 

Our scientists are experienced in iPSC differentiation, with the ability to create dopaminergic neurons, motor neurons, astrocytes, glial restricted cells, retinal ganglion cells, cardiomyocytes, and hepatocytes.

We also offer CRISPR-Cas9 genome editing, via our business partner, if your cells require gene-editing. This range of experience makes REPROCELL your ideal partner for regenerative medicine.

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Interested in clinical grade stem cells?

If you are looking for GMP iPSC suitable for your therapeutic projects, please contact us using the form below. Alternatively, you can reach out via our other channels. We look forward to hearing from you.