GMP Manufacturing
Elevate Your iPSC Manufacturing with Pluristyx's Comprehensive GMP Services.
iPSC GMP Manufacturing Expertise
Pluristyx provides the required regulatory and quality support to generate clinical grade stem cell line starting material for your downstream product GMP 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.
Pluristyx's mRNA cellular reprogramming approach can be used to generate iPSCs under phase appropriate GMP settings or in regulatory compliant clean room conditions. Pluristyx experts will work to customize a process that fits in your desired workflow. Our stem cell and gene editing services are designed to support products through all stages of clinical development. We also provide tech transfer to third parties that can support your Drug Substance and Drug Product manufacturing needs.
Early stage
specialists
Pluristyx specializes in early stage development by working with groups to generate the highest quality iPSC starting material cell lines for their unique cell-based products.
Phase-appropriate GMP manufacturing
Regulatory compliant and customized GMP manufacturing services that meet your needs at every stage of the cell therapy journey.
Quality from
the start
Pluristyx utilizes clinical grade iPSCs and laboratory development processes geared toward GMP manufacturing.
Expedited
tech transfer
Seamless transition from Process/Analytical Development to clean room operations within Pluristyx and to trusted CDMO partners instead of unknown 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.
Comprehensive GMP Services and iPSC Manufacturing Expertise
At Pluristyx, we understand the critical importance of iPSCs in revolutionizing the fields of regenerative medicine, drug discovery, and disease modeling. Pluristyx can serve as a trusted iPSC CDMO to bring your concept to clinic and enable, Tomorrow's Cell Therapies, Today®.
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 cGMP manufacturing services designed to support you every step of the way. Working with Pluristyx ensures a seamless journey from initial cell derivation to the creation of genetically-modified induced Pluripotent Stem Cell (iPSC) Master and Working Cell Banks. These banks can serve as the building blocks for the next generation of cell therapy products.
End-to-End Support
Our comprehensive support for clinical iPSC manufacturing services begins with cell derivation and reprogramming, utilizing our proprietary footprint-free reprogramming method to generate high-quality iPSCs from regulatory-appropriate donor material 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 expertise to assist you in generating the clinical starting material you need for downstream Drug Substance and Drug Product manufacturing.
Explore More about our iPSC Solutions
Human Pluripotent Stem Cells
FailSafe®
Contact us for GMP iPSC Manufacturing Services
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.