Analytical Testing Services
Analytical Testing Services for CGT and ATMPs
Pharmaron brings extensive experience as an analytical CRO, supporting a wide range of Advanced Therapy Medicinal Products (ATMPs), with a strong focus on cell and gene therapies. We combine scientific expertise and regulatory insight to deliver robust, validated methods for complex modalities.
Key Capabilities:
- Critical Quality Attribute (CQA) Testing: Identity, purity, and strength/potency aligned with regulatory expectations for product release and stability.
- End-to-End Analytical Solutions: Method development, GMP validation, non-clinical and clinical study support, stability studies, process continuity assessment, and commercial release testing.
- Proven Track Record: Supported over 100 customers/programs in the past five years across diverse platform technologies.
- Regulatory Alignment: Methods and processes designed to meet global regulatory standards.
Capabilities
Relative Potency Assays
Product potency measures the biological activity and therapeutic potential of a therapy, supporting dose–response assessment and ensuring regulatory compliance. In line with global regulatory guidelines, Pharmaron develops customized potency assays across multiple CGT modalities—leveraging platforms such as reporter gene assays, flow cytometry, ELISA, LC-MS/MS, and RT-qPCR. These cell-based functional and gene expression assays are tailored to each therapy and supported by robust design, optimization, and validation.
Product Identity Testing
Product identity is a key quality attribute for cell and gene therapy, confirming that the product matches its intended vector, transgene, or cell markers. It ensures consistency, regulatory compliance, and patient safety. Pharmaron provides comprehensive identity testing using flow cytometry, qPCR, sequencing, and immunoassays.
Product Purity Assessment
Product purity is a critical quality attribute for cell and gene therapy, ensuring products are free from impurities like residual host proteins, nucleic acids, empty capsids, or unwanted cell populations. Purity directly impacts safety, efficacy, and regulatory compliance. Pharmaron provides advanced testing using flow cytometry, HPLC, LC-MS/MS, ELISA, and qPCR.
Applications
- Core competency in de novo development and/or transfer of in vitro assays to analytically support the CGT products
- Phase-appropriate approach to support therapeutic development from IND submission to market approval (GMP)
- On-site biostatistician support
- Complementary GxP master and working cell banking capabilities
