Intertek Pharmaceutical Services

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Intertek Pharmaceutical Services


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Lab Biography

Intertek Pharmaceutical Services provides end-to-end analytical and regulatory support for pharmaceutical and biopharmaceutical development. Across our GMP, GLP, and GCP-compliant laboratories, including our centre of excellence in Manchester, we support clients developing small molecules, biologics, oligonucleotides, cell and gene therapies, and vaccines. We work closely with our partners from early-phase development through to commercialisation, offering services such as method development and validation, bioanalysis, stability studies, extractables and leachables, CMC support, and batch release testing. By combining deep scientific expertise with regulatory insight, we help clients accelerate their development timelines while ensuring quality and compliance with global regulatory standards including FDA, EMA, MHRA, and ICH.

Qualifications

  • cGMP-compliant laboratories for analytical, CMC, and batch release testing
  • GLP-compliant testing for pharmaceutical and agrochemical studies
  • GCP-compliant bioanalytical services for clinical trials
  • MHRA-approved for both GLP and GMP
  • Human Tissue Authority (HTA) licence for regulated clinical sample analysis
  • UK Home Office Controlled Drugs Licence for handling scheduled substances
  • Regulatory alignment with FDA, EMA, MHRA, Health Canada, TGA, and others
  • Global ISO and quality accreditations

Standards & Methodologies

Bioanalytical Methodologies

  • ELISA
  • MSD / ECL
  • Gyrolab / Simoa
  • Domain Specificity & Competition Assays
  • Cell-Based Potency Assays
  • Neutralising Antibody (NAb) Assays
  • Receptor Occupancy Assays
  • LC-MS/MS
  • Hybrid LBA–LC-MS Assays
  • qPCR / Digital PCR
  • NGS / WGS
  • Flow Cytometry
  • Immunophenotyping
  • Intracellular Cytokine Staining
  • Ex Vivo Whole Blood Stimulation Assays
  • Biomarker Secretion Profiling

Analytical Methodologies

  • HPLC / UPLC
  • GC / GC-MS
  • LC-MS / UPLC-MS
  • ICP-MS / ICP-OES
  • Karl Fischer Titration
  • Combustion Analysis
  • NMR Spectroscopy
  • FT-IR / UV-Vis
  • High-Resolution Mass Spectrometry (HRMS, QToF)
  • XRPD / DSC / TGA
  • Particle Size Analysis
  • Osmolality / pH / Viscosity Testing
  • Dissolution and Disintegration Testing
  • Forced Degradation and Photostability Studies
  • Accelerated and Real-Time Stability Testing
  • Extractables & Leachables (E&L)

Industry Types Served

Biotechnology & Life Science Products, Chemicals & Petrochemicals, Medical Devices & Healthcare Products, Pharmaceuticals & Biopharmaceuticals

Lab Testing Types Offered

  • ADME & Metabolism Studies
  • Bioassays & Functional Testing
  • Biochemistry & Metabolic Analysis
  • Bioinformatics & Computational Biology
  • Biomarkers & Oncology Studies
  • Cell & Tissue Culture
  • Chromatography & Spectroscopy
  • Clinical Chemistry & Metabolite Studies
  • Clinical Microbiology & Culture
  • Extractables
  • Leachables & Impurity Testing
  • Formulation
  • Deformulation & R&D
  • Immunology & Autoimmune Testing
  • Immunology & Immunoassays
  • Infectious Disease & Serology Testing
  • Medical & Clinical Testing
  • Microscopy & Imaging
  • Molecular & Genetic Testing
  • Nanoparticle & Nanoscale Characterization
  • Pharmacology & Drug Development
  • Pharmacology & Therapeutic Drug Monitoring (TDM)
  • Preclinical & Toxicology Studies
  • Proteomics & Protein Analysis
  • Stability & Shelf-Life Studies
  • Toxicology & Biocompatibility Testing
  • Toxicology & Safety Assessments

Location

Manchester, Greater Manchester, England, United Kingdom

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