Vaccine Characterization and Bioanalytical Support
Product Description
Intertek Analytical Services
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GB
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2015On CPHI since
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4Certificates
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1000 - 4999Employees
Company types
Primary activities
Categories
Specifications
Intertek Analytical Services
-
GB
-
2015On CPHI since
-
4Certificates
-
1000 - 4999Employees
Company types
Primary activities
More Products from Intertek Analytical Services (99)
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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... -
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... -
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... -
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... -
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... -
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... -
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... -
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... -
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... -
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... -
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... -
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)
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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.
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