Protein Therapeutic Glycosylation Studies

Protein Therapeutic Glycosylation Studies
Product Description

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 support our clients throughout early stage development to product characterization and regulatory submission. 

To learn more, visit our website: 

www.intertek.com/pharmaceutical/biopharmaceuticals/glycosylation-studies

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)

  • Vaccine Characterization and Bioanalytical Support

    Product Vaccine Characterization and Bioanalytical Support

    Our vaccines development experts provide a suite of services supporting the analysis and quality control of process and batch release samples and stability studies. We have support the development of a range of vaccines including mRNA, protein, glycoprotein, DNA, carbohydrate, lipopolysaccharide, lipi...
  • Biopharmaceutical Product Related Impurities Analysis

    Product Biopharmaceutical Product Related Impurities Analysis

    To address the challenges of product related impurities including truncated and other modified forms, aggregates, precursors and other degradation products arising during processing and/or storage, we deliver detailed characterization in reference to the ICH Q6B Guidance using a diverse range of techn...
  • Viral Vector Characterisation and Release Testing

    Product Viral Vector Characterisation and Release Testing

    Viral vector characterization and release testing services from Intertek's centre of Excellence for Biologics Characterisation, help you to establish and address critical quality attributes (CQAs) that impact product safety, purity, and potency. We deliver robust analytical assays to assess vector pro...
  • 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...
  • 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...
  • Quantitative Immunoassays

    Product Quantitative Immunoassays

    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, opti...
  • 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...

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.