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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.

07AUG20 fda regulatory approval pharmaceuticals-1

Our regulatory support 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 filing with the selected agency.

As we have global access to human tissue samples, we can procure the specimen needed for your cell therapy project and perform the mandatory viral and donor profile screenings to ensure that donor samples 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 clinical-grade media and reagents.

Under strict quality control measures, our clinical-grade iPSC seed clones can be expanded in a GMP environment to manufacture an MCB which can be further downstream processed to generate a final drug product.

About Histocell – our GMP cell manufacturing partner

Clinical iPSC based Cell Therapy Service – Overview

MCB overview pipeline 3

 

FAQs


The StemRNA Clinical Process

REPROCELL's clinical process starts with collecting skin for fibroblast isolation from donors who have provided informed consent for clinical and commercial use and have been thoroughly screened. We then reprogram the fibroblasts to iPSCs using our proprietary StemRNA™ 5.0 Clinical Reprogramming Technology. Multiple iPSC clones are isolated, and quality controlled to create StemRNA Clinical iPSC Seed Clones, which are suitable for further expansion into a GMP iPSC MCB.

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 created corresponding StemRNA Clinical iPSC Pilot Clones from the Clinical Seed Clones for research use.

The difference between Seed Clones and Pilot Clones

Seed clones for MCB generation

StemRNA Clinical iPSC Seed Clones (Clinical-use)

These cells are suitable for clinical use through subsequent regulated and approved processes, including activities resulting in a GMP Master Cell Bank and Working Cell Bank. StemRNA Clinical iPSC Seed Clones are generated on the principles of GMP 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 2

StemRNA Clinical iPSC Pilot Clones (Research-use)

These cells are intended for evaluation purposes only, and they are NOT suitable for downstream therapeutic applications. The ready-to-use StemRNA Clinical iPSC Pilot Clones are created in a research setting and expanded from our GMP-like StemRNA Clinical iPSC Seed Clones. These Pilot clones offer a more cost-effective way to explore the potential of our Clinical Seed iPSCs for developing and optimizing your processes.

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 our experts

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

GMP iPSC - QC data - Morphology

Karyology

GMP iPSC - QC data - Karyology

Flow cytometry analysis 

GMP iPSC - flow cytometry analysis

3-germ layers differentiation potential measured by RT qPCR

GMP iPSC - 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 specifications of batch release assays are suitable for advancement to scale-up for GMP Master Cell Bank manufacturing.

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 were 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.)

Natural Killer (NK) cell differentiation capability of clinical iPSCs

iPSC-derived NK cells Figure-1

Expression of key NK cell surface markers on day 36 of differentiation induction from clinical iPSCs. REPROCELL's clinical iPSCs were differentiated into NK cells (iNK cells) and characterized by flow cytometry. CD45+CD56+ NK cells also expressed NKp44 (CD336), NKp46 (CD335), and NKG2D (CD314). These results demonstrate that NK cells derived from our clinical iPSCs express markers typical of mature and functional NK cells.

Data acquired in collaboration with Tokyo Metropolitan Institute of Medical Science in Japan.

Live imaging of human iNK cells engulfing tumor K562 cells. The elongated human iNK cells demonstrated cytotoxic properties when co-cultured with K562 cells (a human chronic myeloid leukemia cell line), labeled with the cell staining reagent CFSE (green round cells). These results show that iNK cells exhibit mature function in identifying and destroying foreign cells.

Data acquired in collaboration with Tokyo Metropolitan Institute of Medical Science in Japan.

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

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. 

Fibroblasts microscopy cells stained-1

Find out more

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.

Contact our experts