GMP iPSC Production

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

FAQs

Frequently Asked Questions about Clinical iPSCs

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 thorough screening. 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:

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

The difference between Seed Clones and Pilot Clones

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.

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

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.