Intertek Pharmaceutical Services Manchester
The Intertek Pharmaceutical Services Laboratory in Manchester, UK, provides cGMP and GLP/GCP compliant characterization, stability, release testing and bioanalysis - supporting drug development, regulatory submission and production.
For nearly 30 years we have helped the world’s most innovative pharmaceutical and biopharmaceutical companies to navigate challenges of new product development, scale-up, manufacturing and market release. We provide a broad range of Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliant laboratory services to clients involved in the development and manufacture of pharmaceuticals and biopharmaceuticals.
Our GLP & GMP Centre of Excellence in Blackley, Manchester, UK, offers world-class scientific support to clients focused on the development of biologic medicines and advanced therapy medicinal products (ATMP) including biosimilars, proteins, monoclonal & bispecific antibodies, antibody-drug-conjugates, peptides and vaccines. Our programs include protein structural analysis, biophysical & physico-chemical properties and potency testing for use in product characterization packages, stability or batch release. From this facility, we also offer bioanalysis, immunogenicity, biomarker studies, early-stage product characterization and biological activity testing.
We have supported oligonucleotide drug development since the emergence of this product class. Our analytical support expertise includes QC of amidite raw materials, early-stage and late-stage characterization programs to GMP, as well as release testing supporting stability and registration of production. We determine the identity, structure, potency, physicochemical properties, and purity/impurities of your nucleic acid based therapy using a wide range of technologies.
Cell and Gene Therapies
The complexity of ATMPs present challenges to product development and regulatory authorisation. Our analytical development and routine testing can help you meet regulatory expectations for all classes of cell and gene therapies reflecting the current regulatory requirement for adequate characterisation of all materials and components including viral vectors, reagent and excipients.
Bioanalytical and Biomarker Services
Our 30,000 square foot European Centre of Excellence is located in Manchester, UK and delivers fast and cost-effective bioanalysis services including quantitative ligand binding assay, immunogenicity studies, neutralization cell-based assays and biomarker solutions using a suite of diverse bioanalytical technologies.
GMP and CMC Laboratory Services
Our chemistry, manufacturing and controls (CMC) development strategies and Good Manufacturing Practice (GMP) laboratory services can play a key role in reaching your next milestone through regulatory-driven, phase-appropriate GMP analytical services. Our expertise ensures sufficient information for your filings through expert method development and validation, stability studies and GMP batch release testing. Our scientists are adept at applying advanced technology in GMP compliant analytical development programs
In Vitro Toxicology Screening
To determine the toxic potential of compounds early in the drug discovery process you need scientific expertise and customised solutions to address the most complex challenges in toxicity assessments. Our in vitro toxicology screening programs bring together our expertise in toxicology with assay development, method transfer and validation and our scientists work closely with clients to discuss a project in detail to deliver high-quality, reproducible data. Our expanding range of cytotoxic, mechanistic and genotoxic assays complement our bespoke service providing comprehensive assessment of toxicology profiles to help inform your development strategies.
Total Quality Assurance
Bringing quality and safety to life, we respond precisely to your needs with solutions that go beyond just “testing” to help you achieve Total Quality Assurance. Our core strengths and experience in bioanalysis and CMC and GMP laboratory services can help you to meet your development milestones and comply with regulatory expectations.
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The laboratory is inspected and approved by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for GLP and GMP compliance (MHRA Certificate of GMP Compliance for Human Medicines, MHRA Certificate of GMP Compliance for Vet. Medicines).
Intertek also provides Good Clinical Practice (GCP) compliant bioanalytical services for the evaluation of clinical samples and holds a Human Tissue Licence which is regulated and inspected by the Human Tissue Authority UK (HTA).
Intertek Manchester holds a Controlled Drugs Licence, which is regulated by the Home Office.