Bioanalytical immunoassay services for biosimilar development

Biosimilars are increasingly vital in the expanding global biotech market. Achieving regulatory approval requires demonstrating comparable safety and efficacy to approved biological products. The complexity of biosimilar molecules adds unique challenges during development and manufacturing.

Successfully navigating these challenges demands an experienced partner. IQVIA Laboratories offers tailored solutions to help you make informed decisions and achieve validated outcomes throughout your study, from research to commercialization.

Our immunoassay services specialize in developing, transferring, and validating non-clinical and clinical assays crucial for biosimilar studies, including quantitative, immunogenicity, and biomarker assays. We excel in:

• Pharmacokinetic (PK) concentration assays: Developing or transferring quantitative immunoassays efficiently to demonstrate bioanalytical similarity between originator and biosimilar drugs.
• Anti-drug antibody (ADA) assays: Optimizing assays to demonstrate ADA binding comparability, addressing sensitivity and free drug tolerance with advanced techniques.
• Neutralizing antibody (NAb) assays: Tailoring plate-based competitive ligand binding or cell-based approaches specific to your drug’s mode of action.

Our Project Managers, all scientists with hands-on bioanalytical expertise, act as trusted partners throughout your project. They provide regular updates, practical advice, and proactive issue resolution to ensure smooth assay operations.

Integrated within our bioanalytical laboratories and central facilities, our workflow ensures efficiency and flexibility across the product development cycle. IQVIA Laboratories has a proven track record, having developed and tested thousands of biosimilar and comparator samples across various therapeutic areas, including:

• Adalimumab
• Nivolumab
• Pembrolizumab
• Ipilimumab
• Omalizumab
• Rituximab

Whether you need high-throughput assay development or guidance through regulatory complexities, our team is ready to collaborate at every step. Quality is paramount in our bioanalytical lifecycle, from method development to final sample testing reports.

Contact us today to discuss how we can streamline timelines and enhance the success potential of your biosimilar product.