Product Release Testing for Cell and Gene Therapy
Bring your research to the clinic with Bio-Techne’s comprehensive solutions for Cell and Gene Therapy Manufacturing. View our tools for Quality Control testing during cell and gene therapy manufacturing.
Product Release Testing
Rigorous characterization of a cell preparation includes phenotypic, functional, and purity measurements. Confirm the expression of surface markers, activity, and purity at the discovery, pre-clinical, or clinical stage.
| Proteome Profiler™ Antibody Arrays | |
| Blot-based, multianalyte detection of secreted and intracellular signaling molecules | |
| Quantikine™ and DuoSet™ ELISA Kits | |
| Most highly referenced ELISA kits on the market | |
| Luminex® Assays and Luminex High Performance Assays | |
| Quantitative multianalyte detection | |
| Simple Plex™ Assays (at proteinsimple.com) | |
| Automated quantitation of cytokine secretion profiles in <1 hour | |
| Simple Western™ Assays (at proteinsimple.com) | |
| Automated, capillary based immunoassays and size assays | |
| Multicolor Flow Cytometry Kits | |
| Targeting key surface and secreted proteins plus transcription factors |
| Functional Identification Kits for MSC, PSC, and NSC | |
| Confirm the multipotency of your stem cell cultures | |
| GloLive™ Kit and Antibodies for PSC | |
| Confirm stem cell pluripotency and pick colonies for continued culture | |
| Cell Proliferation and Viability Assays | |
| Apoptosis Detection Kits and Reagents | |
| Confirm NK cell cytolytic activity |
| Single-Cell Westerns (at proteinsimple.com) | |
| Chip-based immunoassays to analyze culture heterogeneity | |
| RNAscope® in situ Hybridization Assays (at acd.com) | |
| Analyze genetic construct expression in single cells |
| Micro-Flow Imaging™ (at proteinsimple.com) | |
| Characterize and quantitate sub-visible particles including magnetic beads | |
| Mycoplasma Detection | |
| Microplate-based RNA hybridization assay for the 8 most common mycoplasma species |
Custom Services for Cell Therapy
If your cell therapy program requires unusual quality control testing, take advantage of our scientific expertise in cell characterization. We will work with you to develop and scale up efficient and robust assays to demonstrate the identity and purity of your cells. Learn more about Custom Services for Cell Therapy.