cGMP Cell-based Bioassays
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 Inhalation Product Analysis and Testing
Inhalation product analysis and testing services include particle size and droplet characterization, delivered dose testing, as well as aerodynamic particle size analysis – for pressurized metered-dose inhalers (PMDI), dry powder inhalers (DPI), nebulizers, and soft mist inhalers. Our Good Manufacturin... -
Product Nitrosamine Impurity Testing
Nitrosamine - testing for its impurities: Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) continue to be an area for concern as highlighted by the US FDA and other regulatory authorities. At Intertek we believe flexible solutions are the way forward to overcome technical challenges and ac... -
Product Antibody / Monoclonal antibody therapeutics services
Monoclonal antibody therapeutics: We continually invest in advanced analytical instrumentation that allows us to deliver mAb analytical data with the highest degree of sensitivity, accuracy and resolution. Our experience spans recombinant monoclonal antibodies and related products such as biosimilars, ... -
Product Gene Therapy Characterisation and Release Testing
Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity a... -
Product Clinical Trial Supplies Manufacturing Services
Services for manufacturing clinical trial supplies: To meet your supply needs for investigational medicinal products (IMP) or investigational new drugs (IND) for clinical trials around the world, we provide GMP clinical trial materials manufacturing services. Integrated with raw material testing, ... -
Product mRNA Characterisation and Analysis
Characterization and analysis of mRNA supporting vaccine and therapeutic development, including assessing clinical translation efficiency and immunogenicity. At our GLP / GCP / GMP laboratories, scientists can test a mRNA drug substance or drug product to help you confidently assess batch to batch manufa... -
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 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...
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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