Biotherapeutic immunoassay services

Immunoassays are essential for accurately measuring analytes in complex biological samples, making them pivotal in the field of drug discovery and development. At IQVIA Laboratories, we possess extensive expertise in developing and validating immunoassays within regulated bioanalytical environments. Our proficiency spans scientific understanding, statistical analysis, and navigating today's intricate regulatory landscape.

We excel in project management, offering ample capacity to support high-throughput platforms and complex methods while ensuring compliance. Since 2007, IQVIA Laboratories has been a trusted partner in developing and validating robust bioanalytical ligand-binding immunoassays to support biotherapeutic studies across the drug development continuum.

From pharmacokinetic studies and immunogenicity testing to biomarker assays, including cell-based and ligand-binding neutralizing antibody assays and antidrug antibody assays, our track record in regulated bioanalysis services is proven. Whether you're embarking on preclinical studies or preparing for a Phase III clinical trial, we tailor solutions to meet your project's specific requirements.

At IQVIA Laboratories, we offer comprehensive services to support the development and validation of ligand-binding assays:

• Project Management: Our dedicated Project Managers serve as your primary contacts, ensuring all project expectations—including timelines and costs—are met. Each Project Manager is a seasoned scientist with an average of nine years of industry experience. They actively engage in data analysis, communicate results, and provide recommendations during weekly updates, acting as trusted partners in decision-making for smooth project execution.
• Method Development: Leveraging over a decade of experience in regulated large-molecule bioanalysis, IQVIA Laboratories excels in developing and validating robust bioanalytical methods. We specialize in supporting PK concentration, immunogenicity (ADA and Nab), and biomarker assays for novel agents and biosimilars. Our expert team helps tailor immunogenicity assay formats to meet your project's specific needs, ensuring a seamless transition to validation studies.
• Method Validation: Our production and method development teams collaborate closely to ensure a seamless transition from method development to validation. Before validation begins, a thorough pre-validation checklist verifies method ruggedness, reproducibility, and compliance with regulatory standards. We also provide in-house cut point statistical analysis and prepare critical reagents, staying ahead with industry and regulatory best practices to meet your project's scientific and regulatory requirements.
• Sample Analysis: Equipped with state-of-the-art immunoassay laboratory facilities and platforms such as MSD, ELISA, FL/CL, and Luminex, our large molecule bioanalysis facility conducts high-throughput studies while meeting aggressive timelines.
• Sample Management: With extensive experience in managing large sample volumes on accelerated timelines, IQVIA Laboratories ensures meticulous handling from receipt through final disposition. We maintain strict chain of custody procedures for all client compounds and study samples, managed under rigorous SOPs including quality control measures for critical reagents, metrology, and raw data processing.
• Medical Writing Support: Our in-house medical writing team prepares sample analysis and validation reports that adhere to bioanalytical regulatory guidelines. Each report undergoes three layers of review, typically ready for sponsor review within 2-5 weeks following data QC completion.

IQVIA Laboratories has a proven track record for developing and transferring routine and complex bioanalytical methods. Our focus on quality and our global industry-leading expertise and resources can support a wide range of large-molecule immunoassay studies.

Contact us today to discuss how our experienced bioanalytical team can help you develop and validate your immunoassay in a timely and regulatory-compliant manner.