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Clinical Capabilities

GMP iPSC – Master Cell Bank

GMP Master Cell Bank Manufacturing

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 Banks 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 iPS cell lines will be exclusive to you; available only for your therapeutic project.


 

Why choose REPROCELL?

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

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07AUG20 fda regulatory approval pharmaceuticals-1

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 iPS cell 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.

 

03AUG20 Fibroblasts microscopy cells stained-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 iPS cell needs.

 

03AUG20 Gloved hand pipetting media into cell culture flask-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 iPS cells that do not contain viruses or vectors that could interfere with subsequent differentiation.

 

07AUG20 scientist working in stem cell lab-2

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 iPS cell 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.

REPROCELL will participate at

BioPharm America 2021 conference

20 – 23 Sept, 2021 / Virtual Meeting