Get to Market with a Trusted iPSC Manufacturing Partner
Unlock clinical development of induced pluripotent stem cells (iPSCs) with a flexible platform that has tremendous potential to address scalability issues and improve patient outcomes. Our comprehensive and customized iPSC manufacturing services at our Memphis, TN facility enables you to realize the potential of your therapeutic approach to reach the clinic faster with a commercially viable product.
Our scientists can provide the complete workflow of the iPSC manufacturing process and customize a project to meet your needs. After completing the isolation and reprogramming steps of the iPSC manufacturing process, we offer you several options depending on your intended applications and goals, including:
- iPSC GMP cell banking
- Genetically engineering your iPSCs to introduce specific genetic alterations
- iPSCs differentiation into target cell types, including cardiomyocytes, hepatocytes, islet cells, T cells, NK cells, and CD34+ precursor cells
- iPSCs characterization and release testing
- Fill/Finish
“We are honored to work with Charles River as a worldwide distributor of our pluripotent stem cells, including our genetically modified iPSCs that provide an accelerated path to the clinic with development of safer cell therapies. Through this agreement, we can continue our mission to rapidly advance development of next generation therapies.”
Benjamin Fryer, PhD, Chief Executive Officer, Pluristyx
Start Your iPSC Research and Development with GMP Ready Cell Lines
From iPSC-derived cells to a master bank of CGMP-grade iPSC cells, we can provide what you need for clinical-grade iPSC starting material. With our partnership with Pluristyx, we offer a variety of wild-type and genetically engineered iPSCs containing industry leading FailSafe® technology with an HSV-TK suicide gene "kill switch" system to safeguard against uncontrolled proliferation, genetic mutations, and other safety risks. The iPSC cells are all derived under Good Tissue Practice (cGTP) to support a path to clinic and conform to Global Ethical Standards and Clinical Cell Regulations.
Navigating Complexity from Clinic to Market
In this article, our experts share how to de-risk the cell therapy development process in order to accelerate timelines and streamline CGT manufacturing.
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Secure Your Path to Market with a Scalable iPSC Manufacturing Supply Chain
The path to market with iPSC manufacturing can be laced with challenges across the supply chain. From the intricate iPSC manufacturing process to ensuring scalability and reproducibility, all while adhering to regulatory compliance, progress can be slow. We provide reliable integrated drug discovery and contract development and manufacturing organization (CDMO) services for cell and gene therapies, offering comprehensive pre-scale-up process optimization and the ability to scale at your request. Because we have incorporated continuous commercial readiness into our thinking and service, our streamlined logistics systems ensure the timely delivery of your therapies.
Lead iPSC Innovations with Cutting-Edge Technology
Keep at the forefront of emerging cell therapies when you lean on our scientists and innovative solutions. As the cell and gene therapy (CGT) industry grows, you can continue to leverage our analytical and process development expertise and the most advanced technologies to translate your iPSC therapies from the lab to impactful clinical applications. We maximize iPSC manufacturing with large-scale 3D cell expansion platforms, offering you a scalable and efficient method for cultivating iPSCs. Using specialized bioreactors, we can create an environment that facilitates improved nutrient and oxygen exchange, enhanced cell viability, and higher cell yields.
Leukopaks or iPSCs? Determining Your Ideal Cellular Starting Material
Learn how induced pluripotent stem cells can be successfully used as starting materials for next-gen cell therapies and hear from experts as they compare leukopaks and iPSCs as viable options.
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See How an Efficient iPSC Manufacturing Process Works
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Obtain viable and healthy cells
The first glimpse of a breakthrough in iPSC manufacturing is successful collection, isolation, and reprogramming. Getting these steps right consistently and efficiently sets the stage for making life-changing iPSCs.
Whether you need us to create a master bank of CGMP-grade iPSC cells or iPSC-derived cells ready for the market, we ensure the cells you receive are thriving. With our decades-long experience in cell and gene therapies, you can rely on us to make you the highest quality clinical-grade iPSCs.
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Maintain rigorous quality control and ensure genetic integrity
Implementing strict protocols to safeguard the quality and genetic stability of your iPSCs is a given at Charles River. We’re serious about our science and run regular iPSC quality checks to meet product development timelines. Using our analytical expertise, and thorough testing methods, we keep your cells in an optimal condition at every step of iPSC manufacturing, including during reprogramming and after differentiation into a target cell type.
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Optimize the potential of your iPSC products with end-to-end support
Grow your iPSC products as you scale. Confidently navigate the development of iPSCs with end-to-end support from the initial discovery phase to clinical development and large-scale manufacturing. Our cutting-edge infrastructure, advanced automation, and efficient operations enable high-yield manufacturing of iPSCs. Partner with us for an efficient supply chain and ongoing process improvement to deliver your robust CGMP-grade iPSC products.
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Leverage in-house regulatory expertise
Achieve seamless translation from research to clinic with our deep understanding of regulatory compliance. To help you navigate the regulatory landscape, we have in-house Scientific and Regulatory Advisory Services where you can get up-to-date advice about your iPSC-derived therapies and more.
Frequently Asked Questions (FAQs) About iPSC Manufacturing Services
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How do you make induced pluripotent stem cells?
The process of making iPSCs includes the following steps:
- Collect and isolate adult somatic cells, such as skin fibroblasts or blood cells, from a donor using appropriate techniques.
- Reprogram the cells into a pluripotent state by introducing transcription factors into the cells. For example, Yamanaka transcription factors (Oct4, Sox2, Klf4, and c-Myc) or other alternative factors can generate iPSCs.
- Culture to expand the reprogrammed cells in a specialized medium to support their growth and expansion.
- Characterize the cells to confirm their pluripotency and analyze them for genetic integrity.
- Differentiate iPSCs into targeted cells, which can be used for various research and therapeutic purposes.
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How long does it take to make iPSCs?
The time it takes to make iPSCs can vary between weeks and months, depending on several factors. The factors that influence the iPSC manufacturing process include the type of source cells, the reprogramming technique used, how well the cells culture, and the efficiency of the supply chain.
Are you looking to make iPSCs and need a trusted partner to secure your path to clinic? Talk to our team to learn how we can advance your program.
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What is the success rate of iPSC manufacturing?
The success rate of iPSC manufacturing can vary depending on numerous factors, including the type and quality of source cells, the reprogramming method used, and culturing conditions. The success rate of iPSC manufacturing is typically 0.01% to 5%. Still, under optimal conditions and with the skills for optimized reprogramming methods, an experienced researcher can achieve a substantially higher success rate for generating iPSCs.
