Cell Therapy Development
Solutions for Cell Therapy Development
From Discovery Through Commercialization
Translating cell therapies from the lab to the clinic is costly and time-sensitive. At º£½ÇÆƽâ°æ, we understand the regulatory steps, rigorous reviews, and operational complexities that cell therapy developers face. With more than 30 years of experience enabling biomedical research and well over 100 cell and gene therapy clinical trials globally using º£½ÇÆƽâ°æ products, we deliver high-performance products you can trust, technical expertise you can rely on, and a partnership committed to your success. Read on to learn about our trusted solutions for cell therapy development.
GMP-Compliant Ancillary Materials
Global Compliance by Design
- Use consistent, high-quality products that have been developed following Quality by Design (QbD) principles
- Confidently meet regulatory standards with products designed and manufactured following guidelines for ancillary materials (also referred to as raw materials), such as ISO 20399, USP <1043>, and ICH Q7
- Rely on GMP reagents produced under stringent manufacturing controls and robust quality systems
Safety Testing and Traceability Documentation
- Simplify your regulatory pathway with comprehensive quality and traceability documentation to support your Investigational New Drug (IND) application, clinical trial application (CTA), or other global filings
- Use GMP-compliant products that have undergone extensive testing, including USP sterility, mycoplasma, and endotoxin
- Stay informed with Quality, Supply, and Change Notification Agreements that support your regulatory and operational planning
Custom Manufacturing and Testing Services
- Partner with our Services for Cell Therapy team to ensure your ancillary materials are qualification-ready from early development through commercialization
- Adapt our formulations, packaging, and production to fit seamlessly into your process with flexible product modification options and dedicated manufacturing runs
- Take advantage of custom quality services, including enhanced manufacturing and quality testing (QC) testing controls tailored to your needs
Looking for regulated products?
Reliable Reagents for Clinical Applications
The successful development of a cell therapy depends on the right combination of reagents, protocols, and specialized expertise. º£½ÇÆƽâ°æ offers high-performance products, technical expertise, and dedicated support to help advance your unique therapy from discovery through clinical development and commercialization. Explore our broad range of robust, application-specific solutions that can help confidently advance your unique therapy from discovery through clinical development and commercialization.
T Cell Therapy Development
Enable potency, purity, and scalability in your T cell therapy development.
- Activate T cells without the use of magnetic beads, feeder cells, or antigens by using GMP-compliant ±õ³¾³¾³Ü²Ô´Ç°ä³Ü±ô³Ùâ„¢ T cell activators
- Streamline your T cell therapy workflow by expanding T cells in GMP-compliant ±õ³¾³¾³Ü²Ô´Ç°ä³Ü±ô³Ùâ„¢-XF medium
- Cryopreserve cells with confidence using CryoStor® CS10, a GMP-compliant, serum- and animal component-free cryopreservation medium
- Access regulatory documentation to enable reagent qualification for clinical use and get support transitioning your program to commercial manufacturing
- Additional tools for basic and translational T cell therapy research:
- Source ethically obtained human peripheral blood mononuclear cells (PBMCs) and isolated immune cell subsets
- Differentiate human pluripotent stem cells (hPSCs) or CD34+ hematopoietic stem and progenitor cells (HSPCs) into functional T cells with ³§°Õ·¡²Ñ»å¾±´Ú´Úâ„¢ T Cell Kit and ³§³Ù±ð³¾³§±è²¹²Ôâ„¢ T Cell Generation Kit, respectively
Hematopoietic Cell Therapy Development
Whether you're expanding, editing, or differentiating CD34+ hematopoietic stem and progenitor cells (HSPCs), use tools that deliver consistent performance from research through clinical development:
- Use GMP-compliant ³§³Ù±ð³¾³§±è²¹²Ôâ„¢-AOF for animal origin-free culture and expansion of HSPCs
- Accurately assess HSPC quality and potency using STEMvision™ and MethoCult™—the gold-standard for performing colony-forming unit (CFU) assays in cell therapy development
- Gently cryopreserve HSPCs using CryoStor® CS10, a GMP-compliant, serum- and animal component-free cryopreservation medium
- Additional tools for basic and translational HSPC cell and gene therapy workflows:
- Access cryopreserved HSPCs from cord blood and mobilized peripheral blood, with customizable donor specifications
- Expand, maintain, or differentiate HSPCs with ³§³Ù±ð³¾³§±è²¹²Ôâ„¢ supplements tailored to your specific workflow needs
hPSC-Derived Cell Therapy Development
Developing cell therapy products from hPSCs introduces additional requirements for consistency, safety, reproducible differentiation to functional cell types, and regulatory compliance.
Explore proven hPSC tools for translational and clinical research:
- Maintain hPSCs under GMP-compliant, animal origin-free conditions with °Õ±ð³§¸éâ„¢-´¡°¿¹ó, optimized for clinical workflows
- Support downstream manufacturing with safe, rapid hPSC scale-up in both 2D monolayer culture and 3D suspension culture
- Cryopreserve hPSCs using CryoStor® CS10, a GMP-compliant, serum- and animal component-free cryopreservation medium
- Benchmark or validate hPSC-based workflows with undifferentiated, control human induced pluripotent stem cell (hiPSC) lines from healthy donors
- Reliably differentiate hPSCs with standardized ³§°Õ·¡²Ñ»å¾±´Ú´Úâ„¢ kits for more than 40 different cell types and organoids
Mesenchymal Stromal Cell Therapy Development
MSCs and MSC-derived extracellular vesicles hold immense promise for regenerative medicine and immunomodulatory therapies; however, establishing reproducible MSC cell culture conditions and expansion methods remains a key challenge for clinical translation, due to the inherent biological heterogeneity and variability in MSC therapeutic functions.
Explore MSC culture solutions designed to overcome these barriers and deliver the consistency, scalability, and reproducibility essential for pioneering research and translation of next-generation therapies:
- Expand MSCs with confidence using ²Ñ±ð²õ±ð²Ô°ä³Ü±ô³Ùâ„¢-ACF Plus, formulated to support robust long-term growth while preserving cellular identity and function
- Generate and harvest MSC-derived extracellular vesicles (EVs) with a single cell culture medium using ²Ñ±ð²õ±ð²Ô°ä³Ü±ô³Ùâ„¢-ACF Plus, an animal component- and EV-free formulation
- Support diverse MSC workflows with products optimized for MSCs derived from bone marrow, adipose, umbilical cord, and human pluripotent stem cell (hPSC) sources
- Achieve robust, xeno-free MSC expansion with our GMP-compliant, pathogen-reduced Human Platelet Lysate
- Cryopreserve MSCs using CryoStor® CS10, a GMP-compliant, serum- and animal component-free cryopreservation medium
Regulatory and Compliance Support
Where do you go for support related to compliance, documentation, or custom solutions when qualifying ancillary materials for your project? º£½ÇÆƽâ°æ’s Services for Cell Therapy team has worked with cell therapy developers across multiple clinical trials to qualify reagents for clinical use or delivered customized solutions across all phases of development. Whether you’re preparing your first IND or scaling toward commercialization, we will support your regulatory journey with the quality systems, documentation, and expertise required for clinical success. We have enabled numerous clinical trials and continue to serve cell therapy development groups, biotechnology companies, CDMOs, and pharmaceutical partners as a trusted technical and regulatory ally. To start a conversation about how we can support your unique program, contact your sales representative or connect with us via LiveChat.
