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Clinical Stem Cell Services

GMP iPSC production service for your clinical application

REPROCELL can help with manufacturing your cell therapy product

GMP iPSC Master Cell Banks (MCBs) and subsequent cell therapeutics are manufactured by REPROCELL's iPSC experts in compliance with the regulatory standards and guidelines of the FDA, EMA, and PMDA. Our operational team will provide the necessary quality and regulatory documents such as donor eligibility, CoA, batch records, traceability documentation, and quality technical agreement for your cell therapy project.

07AUG20 fda regulatory approval pharmaceuticals-1

Because we have global access to human tissue samples, we procure the tissues needed for your cell therapy project and perform the necessary viral and donor profile screenings ensuring donors are consented for clinical and commercial use. Our experts use our proprietary footprint-free RNA reprogramming technology to generate a StemRNA™ Clinical iPSC Seed Clone Bank from these tissue samples using GMP-grade media and reagents.

Under strict quality control measures, a clinical grade iPSC seed clone can be expanded in a GMP environment to manufacture an MCB which can be further downstream processed to generate a therapeutic cell product.

Clinical iPSC based Cell Therapy Service – Overview

MCB-overview-pipeline-2

The StemRNA Clinical Process

REPROCELL's process starts with collecting skin for fibroblast isolation from screened donors who gave consent for clinical and commercial use, further reprogramming the fibroblasts to iPSCs using our proprietary StemRNA™ 4th Gen Technology. Multiple iPSC clones are isolated and quality controlled to create StemRNA Clinical iPSC Seed Clones, which are suitable for expansion into a GMP iPSC Master Cell Bank.

These clones can be accessed in three ways:

  1. We can create exclusive StemRNA Clinical Seed Clones for you starting with a donor that matches your criteria.
  2. We also have a bank of ready-to-use StemRNA Clinical iPSC Seed Clones for your evaluation.
  3. We have also created corresponding StemRNA Clinical iPSC Pilot Clones from these Seed Clones.

The difference between Seed Clones and Pilot Clones

Seed clones for MCB generation

StemRNA Clinical iPSC Seed Clones

These cells are suitable for clinical use through subsequent regulated and approved processes, including processes resulting in a GMP Master Cell Bank and Working Cell Bank. StemRNA Clinical iPSC Seed Clones are generated using a CGTP process and covered by a rigorous quality control (QC) process that is compliant with US FDA, European EMA, and Japanese PMDA regulations.

Pilot clones for research use

StemRNA Clinical iPSC Pilot Clones

Our non-exclusive, ready-to-use iPSC Pilot Clones are directly expanded from our StemRNA Clinical iPSC Seed Clones in a research setting. These Pilot iPSC Clones are NOT suitable for development for clinical use but are for evaluation purposes only. They provide a more cost-effective way to access StemRNA Clinical iPSCs to develop and evaluate your process.

Both the Seed Clones and the Pilot Clones include an evaluation period to determine their suitability for your process. During the evaluation period, sufficient vials of the Seed Clones will be reserved for you to carry forth into GMP iPSC Master Cell Bank generation after successful evaluation.

Example of Available StemRNA Clinical iPSC Lines

Donor

Gender

Age

Race

Clinical Status

Blood Type

Donor A

Female

25

Asian
(subcontinental India)

Healthy

B+

Donor B

Female

23

Caucasian

Healthy

A+

Donor C

Female

22

Caucasian

Healthy

0+

Donor D

Male

23

Caucasian

Healthy

A+

Donor E

Male

27

Caucasian

Healthy

A+

  • HLA genotyping data are available upon request.
  • Multiple clones are generally available from each donor.
  • Different clonal lines are validated for their differentiation potential into various specific cell types, including HSCs (hematopoietic stem cells), NSCs (neuronal stem cells), NK (Natural Killer) cells, astrocytes, and iGRPs (induced glia-restricted progenitors).
  • If you are looking for different donor criteria, we can identify and screen a donor that meets your needs.
  • New differentiation data on the various lines are regularly becoming available, which may make it easier to pick the right clonal line to test in your therapeutic project.  

If you want to find out more about our clinical stem cell services, please contact us.

Quality of REPROCELL's iPSCs

REPROCELL is a pioneer in using mRNA for generating iPSCs.  mRNA generates high-quality iPSCs that are uniquely suited for clinical applications.  

  • mRNA is not retained in cells, eliminating concerns of retention of reprogramming vectors.
  • mRNA cannot be integrated into the genome, abrogating the possibility of insertion of reprogramming vectors into the genome.
  • mRNA provides rapid, high-efficiency reprogramming.

To verify the quality of each iPSC line, we perform a multi-level suite of Quality Control assays in line with the regulatory standards.  Examples of a few of our assays are shown below.

QC data of typical StemRNA Clinical iPSCs Clones

Morphology, P6+3

StemEdit - QC data - Morphology

Karyology

StemEdit - QC data - Karyology

Flow cytometry analysis

StemEdit - QC data - Flow Cytometry

3 germ layers differentiation potential

StemEdit - QC data - Germ Layers

Typical quality control assays of Clinical StemRNA iPSC Lines. To verify the suitability of the StemRNA iPSCs as a starting material for clinical programs each clonal line is validated in several assays, including colony morphology and growth rate, karyotyping, pluripotency marker expression by flow cytometry, and directed differentiation to measure their functional pluripotency potential. Only the clones that pass all of these tests are suitable for advancement to scale-up for GMP Master Cell Bank manufacture.

Neural Differentiation capability of clonal iPSC line from donor B

Clinical Stem Cells - Neural Differentiation

Targeted Differentiation Capacity into Neural Lineage of a Typical Clone. Clinical iPSCs are sequentially differentiated into cells of the neural lineage and characterized by fluorescence cytometry. These results show that at various stages of differentiation, the cells express markers typical for Neural Progenitor Cells, iGRPs (induced glia restricted progenitor cells), and astrocytes. (Data acquired in-house.)

You can also outsource your clinical gene editing project to REPROCELL by providing your own cells or using our StemRNA Clinical iPSC Seed Clones.

Explore our StemEdit™ Clinical Gene Editing Service

Commercial license available

Our clients often have concerns about donor consent; but all our tissue donors have fully consented to clinical and commercial use of their cells.

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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Benefits of our GMP Master Cell Bank Service

Also in the following video, REPROCELL’s Chief Operating Officer, Daisuke Usui, summarizes the key benefits of our GMP iPSC Master Cell Bank manufacturing service.

He describes the key milestones achieved in each project, the regulatory standards adhered to, and highlights the benefits of choosing REPROCELL over other providers.

Make an Inquiry

At REPROCELL, our scientists understand that your custom iPSC project must be as unique as your research. If you have any questions about how our Clinical iPSC Generation Service can help you advance your project, please make an inquiry using the form below.