Intertek ASG Laboratory, Manchester, UK > Pharmaceutical and Biopharmaceutical Services

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Pharmaceutical and Biopharmaceutical Services

Intertek ASG provides comprehensive laboratory services in chemical analysis for Pharmaceuticals and Biopharmaceuticals. These including a range of advanced analytical services for complex characterization, problem solving, regulatory analysis and combined regulatory packages. A dedicated routine testing department offers compliant, cost-effective services in more standardized areas of analysis.

The laboratory has been inspected by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) for GLP and GMP compliance and by the United States Food and Drug Administration (FDA) for GMP compliance.

Pharmaceutical and Biopharmaceutical Services Include:

Standard and Routine Services:

• QC services including pharmacopoeial testing of raw materials, intermediates, APIs and finished products
• Long term stability studies
• Pharmaceutical trace element analysis
• Pharmaceutical trace metal analysis
• Physical property prediction and measurement

  
Advanced Analytical Services:

• Method development and validation
• Method remediation and validation
• Characterization of products, impurities and product related impurities (e.g. for CMC sections) by:
• NMR, MS, MS/MS, LC-MS/MS, GCMS, vibrational spectroscopy
• Organic volatile impurity (OVI) and residual solvent analysis
• Characterization of macromolecules including:
• Peptides, proteins and oligonucleotides
• Total protein quantification
• Antibody therapeutics
• Synthetic oligomers and polymers
• Viral particles
• Enyme-Linked ImmunoSorbent Assay (ELISA) testing
• Surfactant analysis in pharmaceuticals, detergents and toiletries
• Chiral analysis:
• Capillary electrophoresis (CE), chiral chromatography and chiral NMR
• Physical sciences analysis:
  • Polymorphism studies, crystal habit
• Biopharmaceutical aggregation studies
• Biopharmaceutical comparability studies
• Biopharmaceutical stability studies
• Early phase stability studies with characterization of degradation products

• Extractables and leachables studies:

  • The interaction and compatibility of pharmaceutical products with packaging
• Ink and colorant analysis for pharmaceuticals
• Rapid NMR screening methods for the detection of counterfeit drugs
• Reference standard materials (RSMs) services

See Also:

• Computational chemistry:

  • Informatics tools for complex data management, visualization and interpretation
• Regulatory packages
• Separation sciences for pharmaceutical analysis
• Chemical and pharmaceutical raw materials testing

Case Studies:

• Biotechnological and Biological Product Analysis and Characterization

For a French version of this page, visit Prestations d'analyses Pharmaceutique.