Biomarker Assays and Validation
Product Description
Intertek Analytical Services
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GB -
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 cGMP Cell-based Bioassays
Cell-based bioassays that comply with cGMP: Using a variety of techniques, including cell-based assays, ligand and receptor binding assays, and flexible multiple assay approaches – our potency testing experts offer tailored bioassay method development, method transfer and method validation to ICH Q2 (R1)... -
Product Analytical Research and Development Services
Services for analytical research and development: As your organization focuses on core business goals, you'll require a partner who has a history of providing consistently high-quality regulated compliance testing. Our team are focused on supporting product development, GMP manufacturing and distributio... -
Product Protein Aggregation Analysis and Characterization
Analysis and characterization of protein aggregates: The services provided by our experts include a range of protein aggregation analysis techniques that are used to detect and quantify aggregates in solution in support of formulation development, quality control, stability studies, comparability, rel... -
Product Genotoxic Impurities ID and Quantification
Identification and quantification of genotoxic impurities: To reduce drug safety and quality risks, diagnosing and limiting genotoxic impurities early on in drug development can reduce risk associated with genotoxic impurities. With the implementation of increasingly stringent regulations for impurity l... -
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 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 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... -
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...
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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