ATMP Analytical Development Services
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 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 ... -
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... -
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... -
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... -
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... -
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... -
Product Isolation and Characterization of Product-related Impurities
Intertek offers product-related impurity analysis in line with ICH Q6B with laboratory-scale isolation and a range of chromatography or mass spectrometry approaches. Our experienced scientists perform detailed characterization using a diverse range of technologies which include MALDI-MS, LC-MSMS, HPLC...
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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