Quantitative Immunoassays

Quantitative Immunoassays
Product Description

Intertek offers quantitative immunoassays such as ligand binding assays for toxicokinetic and pharmacokinetic studies supporting biologic preclinical and clinical development. Our capabilities for quantitative immunoassays include developing methods for biologics and biosimilars, method transfer, optimization and validation of existing methods (including kit assays) suitable for use in TK and PK studies. Utilizing a variety of detection platforms, including enzyme-linked immunosorbent assay (ELISA) and electrochemiluminescence (ECL), we follow Good Laboratory Practice (GLP) guidelines to provide accurate test results and verifiable, reproducible data that can assist you in compressing timelines whilst meeting the requirements for the drug approval process.
To learn more, visit our website:
www.intertek.com/pharmaceutical/immunochemistry/quantitative-immunoassays

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
Specifications
  • Supplied from
    United Kingdom

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain

More Products from Intertek Analytical Services (99)

  • Comparability Studies for Biopharmaceuticals

    Product Comparability Studies for Biopharmaceuticals

    We design bespoke analytical programmes that ensure that the relevant quality attributes for your drug substance or product are evaluated to support your manufacturing process changes. We select analytics referenced by the ICH Q6B to examine the product's structural features (primary, secondary and&nb...
  • Residual DNA Testing for Cell and Gene Therapies

    Product Residual DNA Testing for Cell and Gene Therapies

    Our scientists use Real-time qPCR and digital droplet PCR (ddPCR) techniques for robust quantification to support process validation, monitor batch to batch variation and support of GMP lot release, helping to ensure that products produced from a range of common host cell lines (HEK293, E.coli an...
  • Pharmaceutical Impurity Testing

    Product Pharmaceutical Impurity Testing

    Our GMP compliant laboratories provide pharmaceutical impurity testing for new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)) which can support your product development from an early stage and across the lifecycle of your drug product including method development / validation and di...
  • Protein Therapeutic Glycosylation Studies

    Product Protein Therapeutic Glycosylation Studies

    In line with ICH Q6B, we deliver glycosylation analysis for proteins, antibodies, bispecifics including assessment of the glycosylation site, carbohydrate content and glycan structure. With a range of MS approaches, our protein characterisation scientists provide detailed glycosylation studies designed to ...
  • ATMP Analytical Development Services

    Product ATMP Analytical Development Services

    Advanced therapy medicinal product (ATMP) analytical services & chemistry, manufacturing, and control (CMC) support including characterisation, stability and release testing. Our GLP / GCP / GMP laboratories have supported developers and manufacturers for over 20 years through the provision of adv...
  • Protein or Biologics Higher Order Structure Analysis

    Product Protein or Biologics Higher Order Structure Analysis

    We provide higher-order structure analysis to drive insight into the secondary and tertiary structures of protein in “normal “presentation as well as a function of temperature and pH, allowing the study of subtle structure changes that may occur during processing, storage or handling as well as protein agg...
  • Falsified or Counterfeit Medicine Testing

    Product Falsified or Counterfeit Medicine Testing

    Our falsified medicine analysis expertise is ideally positioned to address the highly technical issues involved in investigating the increasingly sophisticated falsified medicines or counterfeit medicines being discovered in legitimate supply chains. As a key tool in our pharmaceutical supply chain su...
  • Elemental Analysis and Trace Metals (ICH Q3D, USP 233/232)

    Product Elemental Analysis and Trace Metals (ICH Q3D, USP 233/232)

    We provide pharmaceutical organic and inorganic elemental analysis from trace levels to percent levels. Trace metals testing is a routine activity for our Good Manufacturing Practice (GMP) laboratories and is carried out in accordance with pharmacopeia methods such as the United States Pharm...
  • GMP Auditing

    Product GMP Auditing

    Intertek design audit and action plans to meet the requirements of pharmaceutical clients to ensure compliance with EC standards, FDA regulations and WHO concerns. During a pharmaceutical audit process, Intertek takes a "snapshot" of the company's existing quality system, and superimposes it on the referen...
  • Isolation and Characterization of Product-related Impurities

    Product Isolation and Characterization of Product-related Impurities

    Intertek offers product-related impurity analysis in line with ICH Q6B with laboratory-scale isolation and a range of chromatography or mass spectrometry approaches. Our experienced scientists perform detailed characterization using a diverse range of technologies which include MALDI-MS, LC-MSMS, HPLC...
  • Biocompatibility - E and L Studies for Medical Device or Combination Products

    Product Biocompatibility - E and L Studies for Medical Device or Combination Products

    To ensure patient safety, precise knowledge about potential contamination associated with medical device materials is critical. For this reason, a robust chemical characterization is the first and mandatory step of any biocompatibility study which is performed according to the most recent version of the IS...
  • Immunogenicity Assays

    Product Immunogenicity Assays

    Intertek offers immunogenicity assays for detection of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) in support of nonclinical and clinical studies. Our immunogenicity assay experts utilize a multi-tiered approach to measure ADAs and NAbs, and are experienced in the development and va...

Intertek Analytical Services resources (2)

  • News Boosting in Vitro Testing for Nasal Drug Products

    In Vitro Test Methods for Nasal Drug Products VIDEO: Learn how our Alberta Idealised Nasal Inlet (AINI) capability can deliver enhanced IVBE studies for generics and support the development of novel intranasal products targeting specific nasal regions 
  • Brochure Brochure - Pharmaceutical Services

    Covering our full breadth of contract laboratory services, auditing and regulatory consultancy expertise, this brochures provides a summary of our global capabilities.
    Visit www.intertek.com/pharmaceutical for more information.