Cell Therapy CDMO Services
Successful Cell Therapy CDMO services start with process and analytics development and continues throughout the entire manufacturing to commercialization path to deliver life-saving care to patients.
We understand the complexities, regulatory hurdles, and production bottlenecks that can stymie breakthrough drug therapies. Our streamlined and scalable approach uses industry-leading science and technology to ensure your drug development journey meets deadlines, mitigates risks, and passes the highest regulatory standards. Let us be your trusted partner for Cell Therapy CDMO services.
Your Trusted Partner for Cell Therapy GMP Manufacturing & Processes
As an end-to-end cell therapy CDMO, we excel in managing all phases of your product development lifecycle and associated supply chain, facilitating a seamless journey from cellular starting materials to process development to Good Manufacturing Practices (GMP) and commercialization. With integrated quality control and analytical development, our scientific expertise allows us to ensure the safety, quality, and efficacy of products, while meeting the highest regulatory standards and maintaining efficient production timelines.
Accelerate Your Cell Therapy Manufacturing Program
An experienced CDMO, we offer cell therapy manufacturing services for autologous and allogeneic cell types and starting materials, including marrow-infiltrating lymphocytes (MILs), dendritic cells (DCs), natural killer (NK) cells, T-cells, CAR-T, bone marrow-derived mesenchymal stem cells (BMSCs), mesenchymal stem cells (MSCs), whole blood, apheresis, leukapheresis, tumor isolates, and stem cells.
In addition, we have experience handling TILs, tumors (resections/biopsies/lysate), and apheresis material, including mobilized, whole blood, and buffy coat. Learn more about cell solutions.
Tech agnostic and experienced with leading-edge platforms, we provide a comprehensive, data-driven phase-appropriate approach that reduces risk and meets all cell therapy GMP manufacturing guidelines. By integrating cell therapy tech transfer and commercial readiness early in the product development lifecycle, we reduce late-stage CMC challenges and speed time to market.
With already validated systems, our teams have optimized and scalable cell therapy manufacturing processes and analytics on closed and automated systems for all or part of your drug development needs.
Cell Therapy CDMO Support
Cell Therapy Supply Chain Solutions for Minimizing Vein-to-Vein Time
We understand the intricate nature of cell therapy supply chain management within the manufacturing process. As part of our comprehensive services, we specialize in managing supply chain integration to ensure a seamless flow of materials and information throughout the development of cell therapy manufacturing, and commercial production process.
Regulatory Bodies and Facilitating Clinical Trials
We take pride in our role as a trusted partner in your cell therapy manufacturing compliance. We not only support relationships with regulatory bodies and act as your advocate, we interface with additional Contract Manufacturing Organizations (CMOs) and regulatory agencies for global clinical trials and product roll-outs. We understand the importance of seamless coordination and liaise with patient collection facilities and your Contract Research Organizations (CROs). With our expertise and extensive network in cell therapy CDMO services, we are here to ensure that your manufacturing runs smoothly and efficiently, from Phase 1 to commercialization, allowing you to focus on advancing your therapies and bringing your products to market.
Frequently Asked Questions (FAQs) About Cell Therapy Manufacturing
Tell us about your program. Whether you need human immune and stem cell products or CDMO services that include process development, clinical manufacturing, or preparing for commercial scale, we are here to support you. Send us a message describing what you need, and we’ll connect you with the right team.
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