Primera provides high quality bioanalytical services for biological drugs such as monoclonal antibodies, fusion proteins, antibody-drug conjugates, and peptide drugs. Our primary services include assay development and validation, as well as sample analysis for non-clinical and clinical studies in support of PK/PD/Biomarker determinations in GLP, GCP and non-GLP environments. Our assay platforms include ligand-binding based assays and cell-based assays employing a variety of instruments such as ELISA plate reader, MSD, q-PCR, dd-PCR, flow cytometry, ELISpot and 96-well plate automation capacities. Working closely with our Xihua partners in China, we are growing our service capacity and capabilities to meet global client needs.
Primera’s Large Molecule Team provides exceptional services in assay feasibility, development, validation, method transfer and sample analysis. Our strong scientific expertise includes up-to-date regulatory knowledge, extensive industry experience and proficiency in cutting edge instrumentation. Our highly skilled scientists have a proven record of working with challenging therapeutic modalities and complicated biological matrices while providing fast turnaround of data and reports for both GLP and non-GLP projects. Primera’s mission is to provide these high quality services and enable fast turnaround at competitive prices.