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.
Delivering expertise in analytical development, 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 over the last three decades. 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.
Intertek expands pharmaceutical services facility to expedite clients’ biopharmaceutical and gene therapy development
COVID-19 VACCINE OR THERAPEUTIC TESTING & DEVELOPMENT SUPPORT
IMMEDIATE QUESTION? Ask our experts now
FACTSHEET: COVID-19 Vaccine or Therapeutic Testing & Development Outsourcing
ARTICLE: Repurposing Vaccines for Intranasal Development
WEBINAR: Quality Control Strategy for Vaccine Development
WEBINAR: Repurposing Drugs for Inhaled Delivery
eBOOK: Contingency Outsourcing Solutions
Intertek Pharmaceutical Services Manchester
P.O. Box 42
Manchester, M9 8ZS
For location use: M9 8GQ
NEW! Discover our Audit Live Tool for direct access to our scheduled audits
EVENT: 2nd Annual Inhaled and Nasal Biologics/DNA Forum - REGISTRATION IS LIVE
VIDEO:EXTRACTABLES/LEACHABLES LAB TOUR - Request access
WORKSHOP: How to Build an Inhaler (RDD 2023)
PRESENTATION:E&L Strategies (3rd Annual Extractables & Leachables Conference)
TALK: Medical Device Extractables & Leachables Studies
TALK: ID and sensitivity issues during E&L studies
ARTICLE: Glycosylation Analytical Approaches for Antibody Therapeutics
APP NOTE: Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products
ARTICLE: Importance of Aligning a Pharma Audit Scope with the Correct Standard
TALK: mRNA Analytics: Capping Efficiency, Sequencing, Poly-A Tail, dsRNA