Testing Service for Cell Therapy
Cell therapy, which encompasses various treatment modalities such as CAR-T, TCR, TIL, NK, DC, Treg, B cells, and stem cells, represents a class of cutting-edge biotherapeutics aimed at treating and potentially curing a range of diseases, including cancers and genetic disorders. Ensuring the safety, efficacy, and quality of these therapies requires reliable testing services. For autologous therapies, timely delivery of quality control tests is crucial for product release.
Testing Service for Cell Therapy
Cell therapy, which encompasses various treatment modalities such as CAR-T, TCR, TIL, NK, DC, Treg, B cells, and stem cells, represents a class of cutting-edge biotherapeutics aimed at treating and potentially curing a range of diseases, including cancers and genetic disorders. Ensuring the safety, efficacy, and quality of these therapies requires reliable testing services. For autologous therapies, timely delivery of quality control tests is crucial for product release.
Our Expertise
Avance Biosciences is a leading CRO and CTO dedicated to providing analytical and bioanalytical solutions for cell therapy developers. Our comprehensive suite of testing services supports every stage of cell therapy development, from initial research through clinical trials to commercialization. We strive to deliver quality services based on solid science, strict compliance, and exceptional customer care, setting us apart from our competitors.
Analytical Support Through All Stages of Product Lifecycle
Phase
Assay
Description
Development
qPCR, ddPCR, PCR, Sanger, NGS, Single Cell NGS, Nanopore, Flow Cytometry, Southern/Northern analysis, Capillary electrophoresis.
Preclinical Studies
CMC Support
qPCR, ddPCR, PCR, Sanger, NGS, Single Cell NGS, Nanopore, Flow Cytometry, Southern/Northern analysis, Capillary electrophoresis, StemVision, NC-200
- Cell count and viability assays
- Transduction efficiency analysis
- Gene editing profiling
- Activation marker analysis
- Surface marker analysis
- Pluripotency marker analysis
- Immunophenotyping
- Potency assays
- Stability testing
- Replication competent virus testing
- Vector Copy Number (VCN) testing
- Adventitious agents testing
- Sterility testing
- Mycoplasma testing
- Endotoxin testing
- Other release assays
- Custom release assay development and validation
Regulatory Compliance
All testing services are conducted in compliance with Good Laboratory Practice (GLP) and current Good Manufacturing Practice (CGMP) standards, adhering to regulatory guidelines set by agencies such as the FDA and other regulatory bodies worldwide. Our prioritization to not only meet, but to exceed regulatory standards ensures that all data generated is reliable, reproducible, and acceptable for regulatory submissions.
Regulatory Guidance
This final guidance provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products, spanning regulatory review, chemistry, manufacturing, and controls (CMC), pharmacology/toxicology, clinical, and clinical pharmacology topics. This guidance finalizes the draft version issued in...
This guidance is intended to provide industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products and is intended to help facilitate the development of safe, effective, and high-quality CGT products. The FAQs represent common questions...
Allogeneic cells of human origin may be expanded in culture to manufacture medical products consisting of live cells, inactivated cells, cell lysates, or other cell-based materials such as cell-derived particles. We, FDA, are providing you, sponsors of allogeneic cell-based medical products, recommendations for determining the appropriate cell safety testing to...
