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Learn About Our GMP Manufacturing Facilities & Our Investment in the Next Generation of Therapeutics
Simplifying Your Cell and Gene Therapy Process
Revolutionary cell and gene therapies offer significant promise to treat life threatening diseases. Bio-Techne is in this journey with you. As a full-solution ancillary reagent, services, and instrument provider, we will stand by you, providing flexible and pioneering tools to simplify your workflow at every step of the manufacturing process. From CAR T cells to pluripotent stem cells and viral vector manufacturing, let us help you get your therapy to market.
Click through the tiles below to learn how we address these goals across all of cell and gene therapy.
- Innovation
- Scalability
- Flexibility and customization
- Consistency and reproducibility
- Reducing manufacturing risk
Immune Cell Therapy
Immune Cell Therapy
Harness the power of immune cells to attack specific tumor cell populations. Isolate, expand, engineer, and characterize your cells with our premium reagents, services, and instruments.
- GMP cytokines and xeno-free media
- Analytical instruments, immunoassays, and flow cytometry
- RNAscope™ ISH Assays, GCLP-compliant
Regenerative Medicine
Regenerative Medicine
Break new ground with revolutionary therapeutic field built on the flexibility of stem cells. We offer a vast array of products and services to help you advance and manufacture treatments for degenerative diseases, tissue injury, and genetic defects.
- GMP cytokines and animal component-free iPSC medium
- GMP small molecules
- Analytical instruments, immunoassays, and flow cytometry
- RNAscope™ ISH Assays, GCLP-compliant
Gene Therapy
Gene Therapy
Target genetic diseases with gene replacement, knock-out, and gene introduction therapies. Build a robust viral (AAV) or non-viral vector manufacturing program.
- Simple Western™
- Simple Plex™
- iCE Maurice™
- Micro-Flow Imaging™
GMP Capabilities
GMP Capabilities
We strive to reduce your manufacturing risks by providing industry-leading quality, consistency, reliability, and capacity.
- Quality compliance and certifications
- Streamlining transition to GMP
- Custom services
- Animal-free manufacturing
- Our GMP facilities around the world
Analytical Solutions
Analytical Solutions
Rigorously characterize your mid-process and final cell and gene therapy products for the safest possible therapies. Our analytical platforms and assays enable rapid and accurate analysis of cells, viral vectors, molecules, and contaminants.
- Cell phenotyping
- Viral vector analysis
- Contaminant analysis
- Monitoring efficacy and toxicity
Custom Services
Custom Services
Leverage the expertise of our scientists to develop the exact tools you need for manufacturing your cell or gene therapy.
- GMP proteins
- GMP antibodies
- GMP cell processing and engineering services
- Custom cell culture media manufacturing and services
- Custom chemistry services
- Custom vialing of GMP cytokines by mass and activity
Featured Resources for Cell & Gene Therapy Manufacturing
T Cell-Based Therapies eBook
T Cell-Based Therapies eBook
Read about several of the major biological and manufacturing challenges for T cell therapies and how our solutions can help overcome these obstacles at each process stage.
Next-Generation Analytical Solutions for Cell and Gene Therapy eBook
Next-Generation Analytical Solutions for Cell and Gene Therapy eBook
Explore how our array of instrument platforms provides automation and scalability for rapid and accurate characterization, with low-volume sample analysis to help preserve your precious samples.
Discover How Bio-Techne is Supporting the Field of Cell and Gene Therapy With Latest News
- Press releases
- Webinars and presentations
- Meetings and events
Reagents and Services
ExCellerate™ Cell Culture Media
Antibodies for Immune Cell Therapy
Analytical Tools
Fluorokines™ Fluorescent-Labeled Recombinant Proteins
Advanced Western Blotting Solutions for Cell & Gene Therapy
Website Resources
Streamlining Transition to GMP
Serum-Free and Animal-Free Cell Culture
Cell therapies and gene therapies make use of living cells or genetic material rather than small molecule or biologic pharmaceuticals. These therapies are classified as advanced therapy medicinal products (ATMPs) and require specialized manufacturing processes.
In immune cell therapy, specific immune cell types (e.g. T cells, NK cells, regulatory T cells, and dendritic cells) are selected for their ability to detect and target cancer cells. Immune cell therapies most commonly target blood cancers (e.g. leukemias and lymphomas). In the cell therapy manufacturing process, cells are isolated from a patient, genetically engineered to introduce additional therapeutic functions (e.g. CAR-T and CAR-NK cells), activated to their functional state, expanded to achieve clinically useful cell numbers, and processed for final product fill and finish.
Regenerative medicine is often based on stem cells which can be manipulated to enhance tissue repair following disease or trauma. Common indications for regenerative medicine include neurodegenerative diseases, diabetes, muscular dystrophy, and heart disease. Induced pluripotent stem cells (iPSCs) can be differentiated into any of the three germ layers (endoderm, ectoderm, and mesoderm) for production of cells to rebuild any tissue in the body. The manufacturing process for stem cell-derived therapies is similar to that for immune cell therapies but also may contain steps for reprogramming somatic cells to iPSCs and differentiation of iPSCs into the desired cell type.
In gene therapy, DNA or RNA sequences are chosen to replace or inactivate mutated genes or to encode a missing protein. The active agent in gene therapies is this genetic material packaged in a vector for delivery to the defective cell type. Adeno-associated virus (AAV) is the most commonly used vector, although other vectors such as transposons, nanoparticles, polymers, lipids, peptides, and inorganic materials are used as well. Gene therapies target hematological, immunological, neurodegenerative, metabolic disorders, and cancer that arise from genetic defects.
For all cell and gene therapies, thorough analysis is necessary at every stage of the manufacturing process to verify the identity, functionality, and purity of the product. The fully tested and approved cell or gene therapy is then administered to the patient. For manufacturing efficiency, reliability, and scale-up, it is critical to consider raw materials qualification, adoption of GMP-grade materials, reagent and assay customization to fit the process, scaling to increase process output, and the performance of analytical testing.
