card-3216_Biochemistry expert scientific with eyeglasses
Digital innovation

Driving operational improvements and quality of our services

card-3210_Laboratory technicians conduct a series of tests on a chemical analyzer
Science Innovation

Uniquely positioned to shape, validate, and deliver biomarker assessments that strive to improve patient outcomes across diverse Therapeutic Areas

card-3242_Scientist using tablet while colleagues working behind
Download our Corporate brochure

We are IQVIA Laboratories, a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

Download
card-3233_Laboratory scientist working at lab with micropipette, and 96 well plate
Corporate Video

Our commitment to customer success is embedded in every facet of our operations.

card-3210_Laboratory technicians conduct a series of tests on a chemical analyzer
Science Innovation

Uniquely positioned to shape, validate, and deliver biomarker assessments that strive to improve patient outcomes across diverse Therapeutic Areas

card-3216_Biochemistry expert scientific with eyeglasses
Digital Innovation

Driving operational improvements and quality of our services

English You are about to exit for another IQVIA country or region specific website Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. Ok Open in new tab Search
hero bg-3272_scientist in labcoat wearing nitrile gloves, doing experiments in lab

Bioanalytical immunoassay services for biosimilar development

Unique bioanalytic capabilities to accelerate biosimilar studies

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. 

Related Services

card-3229_test tubes for testing

Bioanalytical Services

Learn more
card-3222_Close up of test tubes with blood samples on stand

In Vitro Screening

Learn more
card-3241_Technician holding blood tube test in the research laboratory

Discovery Bioanalysis

Learn more
card-3259_man in laboratory with tablet for medical analysis

Small and Large Molecule LC-MS

Learn more
card-3215_People working at laboratory

Quantitative Assays for Peptides using LC-MS

Learn more
card-3215_People working at laboratory

Biotherapeutic Immunoassay Services

Learn more
card-3233_Laboratory scientist working at lab with micropipette, and 96 well plate

Immunoassay and Immunogenicity

Learn more
card-3275_Young scientist works in modern laboratory

Bioanalytical Immunoassay Services for Biosimilar Development

Learn more
card-3211_Scientist wearing safety glasses

Validated Assays

Learn more
card-3241_Technician holding blood tube test in the research laboratory

Immune Landscape Signatures

Learn more

Related Insights

Managing Informed Consent Samples from Clinical Trials

A set of best practices for the definition, tracking and management of allowable use attributes associated with samples collected in protocol based clinical trials

Biorepository and Specimen Management

Your biological specimens are irreplaceable assets – trust them with a proven partner

ADME Services

Accelerating your drug discovery, preclinical and clinical programs

IQVIA Laboratories Central Laboratory Services

Central laboratory solutions supporting clinical trials around the world

Helping you master your lab data

Improved oversight with your lab data now in full view

NASH and Liver Disease Capabilities

Nonalcoholic Fatty Liver Diseases & Non-alcoholic Steatohepatitis (NAFLD & NASH)

How COVID-19 Changed Clinical Trial Dynamics and Environment

Precision Medicine World Conference 2021 Virtual Presentation

Pediatric Initiative

Optimizing small blood volumes to prevent canceled tests in clinical trials for pediatric patients

Vaccine Laboratory Services

Test Menu

SARS-CoV-2 Vaccine Induced Antibody Profiles

Presented at World Vaccine Congress 2021

See All