GMP Manufacturing

Elevate Your iPSC Manufacturing with Pluristyx's Comprehensive GMP Services.

GMP Manufacturing

Pluristyx provides the required regulatory and quality support to generate clinical starting material for your downstream product manufacturing. We are committed to accelerating the iPSC development process by providing proven consumables and reagents to guarantee our iPSCs function as intended, from thaw to differentiation.   

Early stage
specialists

Pluristyx specializes in the beginning of the cell therapy journey by working with groups to generate the best possible iPSC starting material for their unique cell-based products.  

Phase-appropriate manufacturing

Tailored GMP manufacturing services that meet your needs at every stage of the cell therapy journey.   

Quality from
the start

Pluristyx designs laboratory development activities with an eye toward GMP manufacturing.

Expedited
tech transfer

Seamless transition from Process/Analytical Development to clean room operations between teams within Pluristyx instead of third parties.

Early stage
specialists

Pluristyx specializes in the beginning of the cell therapy journey by working with groups to generate the best possible iPSC starting material for their unique cell-based products.  

Phase-appropriate manufacturing

Tailored GMP manufacturing services that meet your needs at every stage of the cell therapy journey.   

Quality from
the start

Pluristyx designs laboratory development activities with an eye toward GMP manufacturing.

Expedited
Tech Transfer

Seamless transition from Process/Analytical Development to clean room operations between teams within Pluristyx instead of third parties.

Elevate Your iPSC Manufacturing with Pluristyx's Comprehensive GMP Services​

At Pluristyx, we understand the critical importance of iPSCs in revolutionizing the fields of regenerative medicine, drug discovery, and disease modeling. Therefore, we are fully committed to providing you with the tools, expertise, and support necessary to harness the full potential of iPSCs in a clinical setting. That's why we offer customized GMP manufacturing services designed to support you every step of the way, ensuring a seamless journey from initial cell derivation to the creation of genetically-modified induced Pluripotent Stem Cell (iPSC) Master and Working Cell Banks that can serve as the building blocks for the next generation of cell therapy products. 

End-to-end Support

Our end-to-end support for clinical iPSC manufacturing begins with cell derivation and reprogramming, utilizing our proprietary footprint-free RNA reprogramming method to generate high-quality iPSCs from regulatory-appropriate donors with full consent and commercialization rights. Our mRNA reprogramming technology then transforms donor material into genetically-stable iPSCs that can be banked under strict GMP standards to provide the safety and efficacy needed for clinical applications. 

Our commitment doesn't stop there. Pluristyx provides essential regulatory and quality support to assist you in generating the clinical starting material you need for downstream product manufacturing.

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Human Pluripotent Stem Cells

Product
Human pluripotent stem cells (hPSC) for use in R&D activities. Inquire for GMP grade cells suitable as a starting material in clinical applications. All cell lines are registered with the U.S. National Institutes of Health (NIH), are listed in the NIH Human Stem Cell Registry and are eligible for use in NIH-funded research.
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FailSafe®

Technology
A reliable safeguard against transplants becoming tumorigenic – any unwanted cells can be eliminated with a simple source of drug treatment.
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Partner with Pluristyx

Partner with Pluristyx, and together, we can navigate the complexities of GMP manufacturing to deliver clinical-grade iPSCs with the potential to bring the next generation of cell-based therapies to patients in need. Trust in our experience, innovation, and unwavering commitment to quality as we embark on this transformative journey together. 


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