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.
Technical Information
Avance Biosciences pre-validated and then formally validated a cell-based anti-inflammatory functional assay for a cell therapy drug product, confirming cGMP-ready specificity, accuracy, and precision across three operators and three days.
This case study details how Avance Biosciences validated a multi-color flow cytometry identity assay for cGMP cell therapy drug substance release, confirming specificity and precision across five surface markers. The method met predefined acceptance criteria across three analysts and multiple days under a pre-approved validation protocol.
Regulatory Guidance
This guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. We, the FDA, are issuing this guidance to assist you (manufacturers, applicants, and other stakeholders) in developing approaches for assuring the potency of CGT...
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...
