Our dedicated and knowledgeable team members have over 20 years of experience from both CRO and pharmaceutical companies developing and validating immunoassays for large molecules, specifically biotherapeutics and biomarkers, to support pre-clinical, clinical and exploratory studies. Here at Alliance Pharma we develop, transfer, optimize and validate ligand binding assays using ELISA, Meso Scale Discovery, and GyroLab platforms. Our capabilities in immunogenicity testing and cell-based assays have supported our clients in developing a variety of monoclonal antibody drugs and other protein and peptide based therapeutics.We have extensive expertise developing and validating anti-drug antibody (ADA) assays and neutralizing antibody (nAb) assays in plate based and cell based formats.
The Alliance team has recently expanded our bioanalytical services and support in the field of gene therapy. We use oligo hybridization ELISA and qPCR assays to support quantitative assessment of biomarkers and gene therapies, as well as for PK/TK support of oligonucleotides in complex biologic matrices such as blood and tissues. Our experts leverage the latest technology (QuantStudioTM 7) in supporting our wide customer base in both regulated and non-regulated studies through all stages of drug development.
- Method Development, Validation and Sample Analysis for Large Molecules
- Immunoassays for PK/TK Studies
- Immunogenicity Assays (screening, confirmation, titration and nAb determination)
- Cell Based Bioassays (potency, cytotoxicity, genotoxicity and reporter gene assay)
- RNAi, Genotyping, Gene Expression, Mutation and Methylation
- ELISA (Chromogenic, Fluorescence, Luminescence Detection)
- MSD (Meso Sector S600)(Electrochemiluminescence (ECL) Detection)
- qPCR (QuantStudioTM 7)
- Single and Multiplexing