Vaccine Characterization and Bioanalytical Support

Vaccine Characterization and Bioanalytical Support
Product Description

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, lipid and lipoprotein components of vaccines. We also provide characterisation for vaccine delivery systems such as liposomes and nano-lipid nanoparticles. GLP, GCP and GMP vaccine characterisation and bioanalytical support for vaccine developers and manufacturers including stability studies and release testing.

To learn more, visit our website:

www.intertek.com/pharmaceutical/vaccine

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
  • Selling Points
    Quality Service; Reputation
  • Model
    GMP LABORATORY SERVICES
  • Supplied from
    Switzerland; United Kingdom; United States

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)

  • Elemental Impurity Testing ICH Q3D

    Product Elemental Impurity Testing ICH Q3D

    Testing for elemental impurities ICH Q3D: To successfully implement ICH Q3D requirements, our experts in elemental impurities and toxicology can help you develop a compliance strategy. We can provide screening studies and data to aid risk assessment, if this does not already exist, or develop and valida...
  • Biosimilars Testing Services

    Product Biosimilars Testing Services

    Testing services for biosimilars: Our biosimilar analytical comparability programs provide highly relevant data for early stage characterisation and later stage comparison. These programs evaluate and compare all pertinent features of the biosimilar product and are based on the ICH Q6B. Programs encompa...
  • Biomarker Assays and Validation

    Product Biomarker Assays and Validation

    Validation of biomarker assays: Our diverse range of analytical platforms supports biomarker analyses including ELISA, flow cytometry, cell-based assays, multiplex ECL platforms, and high sensitivity measurements using QuanterixSimoa HD-X Analyzer™ measurement instruments. Our dedicated biomarker assay...
  • Liposomal Drug Delivery Technologies Development Support and Analysis

    Product Liposomal Drug Delivery Technologies Development Support and Analysis

    Liposomal drug product characterisation according to the FDA CMC guidance to support your new drug application or biologics license applications. Including: 
    • Physicochemical parameters determined to be CQAs (e.g. particle size, size distribution, zeta-potential and physical stabi...
  • Biologic Quality Control and Release Testing

    Product Biologic Quality Control and Release Testing

    We deliver responsive QC analysis for complex biologic products from our cGMP laboratories. Our scientists develop and validate methods or perform technology transfer of a sponsor's method for a wide range of analytical methods required for batch release testing. We also routinely carry out testing to Phar...
  • Cell-based Neutralization Assays

    Product Cell-based Neutralization Assays

    Experienced cell-based neutralizing antibody assay capabilities. Our experts, at our GLP/GCP compliant laboratory, evaluate each therapeutic, conduct tailored assay development and ensure that each assay is optimized to suitably determine the presence of NAb with maximum possible level of drug toleran...
  • 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...
  • 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 ...

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.