大分子生物分析
Pharmaron offers end-to-end pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity services for therapeutic biologic products. Our bioanalytical experts provide comprehensive study support, from lead identification to Phase IV clinical trials, with robust assay validations adhering to FDA/EMA/ICH regulatory standards.
Capabilities
Our Services
Biologics PK/PD
- De novo development, transfer, and kit-based PK/PD assay support for preclinical and clinical programs
- Assay development and validation for complex programs (e.g. Therapeutic proteins with endogenous counterparts)
- Characterization of drug-dose response by quantitation of targets of interest
- Supported Matrices: Serum, plasma, urine, saliva, feces, bile, lymph, cerebrospinal fluid (CSF), tissue and cell lysates
Our Services
Biomarker and Cytokine Analysis
- Single and multi-plex assays available to best quantify early discovery, preclinical, and clinically meaningful targets for multiple therapeutic indications
- Ability to initiate general screening against potential targets and take relevant biomarkers through preclinical and clinical studies (R&D, GLP, and GcLP)
- Expertise in serum, plasma, PBMC, cell and tissue lysates with the ability to tailor requirements on a program-specific basis
Our Services
Humoral Immune Response
- Development and validation of Anti-drug Antibody (ADA) and Neutralizing Antibody (NAb) assays for pre-clinical and clinical studies tailored to regulatory needs (GLP, GcLP)
- Utilization of cell-based transduction inhibition and plate-based ligand binding assays for inclusion/exclusion criteria and post-dose monitoring as a safety assessment
- Regulatory and Industry-driven strategies for determining cutpoint in populations with pre-existing immunity to a therapeutic
- Adherence to a multi-tiered approach per FDA Guidelines with further ADA characterization for isotyping, epitope specificity, and cross-reactivity
Our Services
Cellular Immune Response
- Establishment of Peripheral blood mononuclear cell (PBMC) assays to detect cellular responses against the test agent, detection of secreted immune molecules or proteins of interest (e.g., interleukins and cytokines)
- Determination of appropriate PBMC preparations for analyzing antigen-specific cells
- Optimized peptide pool concentrations for different assays
