Bioanalytical Services
Ensure success in your discovery, preclinical, and clinical programs. GLP and GCP bioanalytical laboratory and bioanalysis testing support services - for all phases of drug development - including method development and validation.
Intertek has nearly 30 years of experience conducting regulated bioanalytical studies supporting the development of pharmaceuticals, biopharmaceuticals, vaccines, and biosimilars. At our state-of-the-art, GLP-compliant lab located in Manchester, UK, we provide global bioanalysis outsourcing support for small molecule drugs as well as biologics.
Our Total Quality Assurance (TQA) capabilities include proprietary method development, validation, method transfer, high throughput sample analysis, and pharmacokinetic and toxicokinetic support, combined with automated data capture and reporting system. Clinical sample management services are provided for the collection and shipment of samples from clinical study sites.
Recognizing the critical role bioanalysis plays in drug development, our mission is to consistently deliver accurate and reliable data that is subject to rigorous scientific and regulatory review, ensuring the success of your discovery, preclinical, and clinical programs.
Bioanalytical Services for Preclinical and Clinical Studies
- Method Development
- Method Validation
- Lead Optimization Studies
- Pharmacokinetic (PK) Analysis
- Bioavailability Studies
- Bioequivalence Studies
- Dose Formulation Analysis
- GCP Bioanalytical Services
- Bioanalytical Technologies including Liquid Chromatography - Mass Spectrometry, Inductively Coupled Plasma – Mass Spectrometry, Capillary Electrophoresis, and Nuclear Magnetic Resonance Spectroscopy
- Bioanalysis of PEGylated and other Polymer-Linked Drug Assays
- Metals And Elemental Bioanalysis by ICP-MS
Small Molecule Bioanalytical Services
- Quantitative Bioanalytical LC-MS/MS
- Tissue Bioanalysis
Large Molecule Bioanalytical Services
Intertek is a world-leading provider of immunochemistry and biomarker services for bioanalytical studies - supporting the preclinical and clinical development of protein-based therapeutics and other biologic medicines.
- Immunochemistry Services
- Quantitative Immunoassays
- Immunogenicity Assays
- Biomarkers Assays
- Cell-Based Neutralization Assays
- Ligand-Binding Assays
Total Quality Assurance for Bioanalysis in Discovery, Preclinical, and Clinical Programs
By integrating advanced analytical technology with a heritage supporting bio/pharmaceutical product development, our experts offer Total Quality Assurance (TQA) to help you ensure accuracy and reliability of your data. Intertek's innovative pharmaceutical services, which bring quality and safety to life, are consistently delivered with precision, pace, and passion – allowing you, our customer, to power ahead safely.
COVID-19 VACCINE OR THERAPEUTIC TESTING & DEVELOPMENT SUPPORT
IMMEDIATE QUESTION? Ask our experts now
FACTSHEET: COVID-19 Vaccine or Therapeutic Testing & Development Outsourcing
ARTICLE: Repurposing Vaccines for Intranasal Development
WEBINAR: Quality Control Strategy for Vaccine Development
WEBINAR: Repurposing Drugs for Inhaled Delivery
eBOOK: Contingency Outsourcing Solutions
NEW! Discover our Audit Live Tool for direct access to our scheduled audits
EVENT: 2nd Annual Inhaled and Nasal Biologics/DNA Forum - REGISTRATION IS LIVE
VIDEO:EXTRACTABLES/LEACHABLES LAB TOUR - Request access
WORKSHOP: How to Build an Inhaler (RDD 2023)
PRESENTATION:E&L Strategies (3rd Annual Extractables & Leachables Conference)
TALK: Medical Device Extractables & Leachables Studies
TALK: ID and sensitivity issues during E&L studies
ARTICLE: Glycosylation Analytical Approaches for Antibody Therapeutics
APP NOTE: Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products
ARTICLE: Importance of Aligning a Pharma Audit Scope with the Correct Standard
TALK: mRNA Analytics: Capping Efficiency, Sequencing, Poly-A Tail, dsRNA
Discover our services
- In vitro Toxicology Screening Services to Help Minimise Liabilities and Inform Drug Development Strategies
Learn more - Drug Tolerance Assessment and Improvement in Cell Based NAb Assays Using Response Data Modeling
Learn more - Bioanalysis and Toxicology Challenges with ADC: How are They Different and New?
Hosted by the Bioanalysis Zone
Learn More - Overcoming Challenges in the Development and Validation of Biologics and Small Molecules in Ocular Tissues
Hosted by the Bioanalysis Zone
Learn more - Impact of Recent Changes to FDA Immunogenicity Draft Guidance
Hosted by the Bioanalysis Zone
Learn more - Additional webinars
RESOURCES
Brochure Downloads:
Bioanalysis Services Brochure
Trace Metals Bioanalysis and Biomarker Quantification
White Paper Downloads:
Biomarker Development and Validation
Bioanalysis Of Pegylated Species In Human Plasma By NMR