1
Nov
2022

Intertek Pharmaceutical Services

Exhibitor at CPHI Frankfurt 2022 stand 90H41, CRO & Clinical Trials Zone
About Us

For over 30 years our scientists have delivered high-quality technical services from our GLP/GCP/GMP laboratories across (bio)pharma, cell & gene therapies, mRNA, oligos and vaccines products categories. Centers of Excellence:

  • Inhalation Product Development 
  • Biologics Characterization 
  • GMP Analysis 
  • Method Development/Validation 
  • GLP/GCP Bioanalysis 
  • ICH Stability Storage/Testing 
  • Extractables/Leachables
  • Formulation Development
  • Clinical Trial Manufacturing

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
Contact info
Event information
CPHI Frankfurt 2022
  • 1-3 November 2022
  • Messe Frankfurt, Germany
  • Visit us at stand 90H41, CRO & Clinical Trials Zone

Products Featured at CPHI Frankfurt 2022

  • Intertek Pharmaceutical Services

    Product Intertek Pharmaceutical Services

    Intertek's pharmaceutical contract laboratory services, regulatory assistance, and supply chain assurance deliver quality and safety to meet your unique pharma and biopharma outsourcing needs. We bring quality and safety to life!

    With our pharmaceutical experts working with you at every sta...
  • Biopharmaceutical Characterisation and Testing Services

    Product Biopharmaceutical Characterisation and Testing Services

    Characterization and testing of biopharmaceuticals: Using our expert's insight into a biologic's structure, physicochemical properties, potency, and impurity profile, we help you meet your development milestones.

    A range of expertise is available, including assessment of structure, h...
  • Inhalation Drug Product Development Services

    Product Inhalation Drug Product Development Services

    Services for the development of inhalation drugs: Our team have over 30 years of experience supporting our clients' product development for orally inhaled or nasal drug products (OINDP). This includes formulation, stability, testing, product performance testing, in vitro bioequivalence studies, CMC su...
  • Drug Stability Testing and ICH Storage Outsourcing

    Product Drug Stability Testing and ICH Storage Outsourcing

    Testing of pharmaceutical stability and ICH storage outsourcing: Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every location. ...
  • GMP and CMC Laboratory Services

    Product GMP and CMC Laboratory Services

    Laboratory services according to GMP and CMC: We provide regulatory-driven, phase-appropriate laboratory services, supporting CMC programs from preformulation to formulation to product release. Among our capabilities are centres of excellence for method development and validation, analysis, stability stud...
  • Oligonucleotide Analytical Development Services

    Product Oligonucleotide Analytical Development Services

    Analytical development services for oligonucleotides: For oligo-based drugs, our capabilities range from GLP bioanalysis to GLP/cGMP characterisation. We support product development, from quality control testing of amidite starting materials and early stage product characterization through to GMP batch rele...
  • Bioanalytical Services (GLP/GCP)

    Product Bioanalytical Services (GLP/GCP)

    Services for Bioanalysis (GLP/GCP): In our state-of-the-art facilities, we provide GLP/GCP method development, validation, method transfer, sample analysis and pharmacokinetic and toxicokinetic support, along with automated data collection and reporting systems. Over the past 20 years, we have supported th...
  • Development and Validation of Analytical Methods

    Product Development and Validation of Analytical Methods

    Analytical methods development and validation: Our method development scientists work with a broad range of products, methods, and analytical technologies (chromatography, mass spectrometry, spectroscopy, biophysical analysis, bioanalytical techniques, etc.) to ensure that the method will meet its intend...
  • Formulation Development including Inhaled Products

    Product Formulation Development including Inhaled Products

    Inhaled products and formulation development: The development of drugs using experimental design approaches with integrated stability testing and storage is available from us. Our formulation specialists can provide a wide range of formulations in a timely and cost-effective manner in order to identify the ...
  • Nasal Drug Development

    Product Nasal Drug Development

    Development of nasal drugs: Scientists from our nasal drug development team provide method development, validation, and testing services to help you optimise the performance of your aqueous, powder, and propellant-driven nasal drug products. Conducted in Good Manufacturing Compliant (GMP) laboratorie...
  • Extractables and Leachables Testing Services

    Product Extractables and Leachables Testing Services

    Testing for extractables and leachables: Our scientists perform extractables and leachables testing based on regionally specific guidelines (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <665>, <1663>, <1...
  • Bispecific Antibody Characterisation

    Product Bispecific Antibody Characterisation

    Characterisation of bispecific antibodies supporting regulatory considerations for therapeutic development. Our scientists offer BsAb characterisation, with a focus on monitoring relevant CQAs. We can help you to demonstrate consistency or comparability of manufactured batches or as release tests for clinica...
  • Inhalation Product Analysis and Testing

    Product Inhalation Product Analysis and Testing

    Inhalation product analysis and testing services include particle size and droplet characterization, delivered dose testing, as well as aerodynamic particle size analysis – for pressurized metered-dose inhalers (PMDI), dry powder inhalers (DPI), nebulizers, and soft mist inhalers. Our Good Manufacturing P...
  • Nitrosamine Impurity Testing

    Product Nitrosamine Impurity Testing

    Nitrosamine - testing for its impurities: Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) continue to be an area for concern as highlighted by the US FDA and other regulatory authorities. At Intertek we believe flexible solutions are the way forward to overcome technical challenges and achie...
  • Antibody / Monoclonal antibody therapeutics services

    Product Antibody / Monoclonal antibody therapeutics services

    Monoclonal antibody therapeutics: We continually invest in advanced analytical instrumentation that allows us to deliver mAb analytical data with the highest degree of sensitivity, accuracy and resolution. Our experience spans recombinant monoclonal antibodies and related products such as biosimilars, fus...
  • Gene Therapy Characterisation and Release Testing

    Product Gene Therapy Characterisation and Release Testing

    Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity and ...
  • Clinical Trial Supplies Manufacturing Services

    Product Clinical Trial Supplies Manufacturing Services

    Services for manufacturing clinical trial supplies: To meet your supply needs for investigational medicinal products (IMP) or investigational new drugs (IND) for clinical trials around the world, we provide GMP clinical trial materials manufacturing services. Integrated with raw material testing, sou...
  • mRNA Characterisation and Analysis

    Product mRNA Characterisation and Analysis

    Characterization and analysis of mRNA supporting vaccine and therapeutic development, including assessing clinical translation efficiency and immunogenicity. At our GLP / GCP / GMP laboratories, scientists can test a mRNA drug substance or drug product to help you confidently assess batch to batch manufactu...
  • cGMP Cell-based Bioassays

    Product cGMP Cell-based Bioassays

    Cell-based bioassays that comply with cGMP: Using a variety of techniques, including cell-based assays, ligand and receptor binding assays, and flexible multiple assay approaches – our potency testing experts offer tailored bioassay method development, method transfer and method validation to ICH Q2 (R1) s...
  • Analytical Research and Development Services

    Product Analytical Research and Development Services

    Services for analytical research and development: As your organization focuses on core business goals, you'll require a partner who has a history of providing consistently high-quality regulated compliance testing. Our team are focused on supporting product development, GMP manufacturing and distribution, ...
  • Protein Aggregation Analysis and Characterization

    Product Protein Aggregation Analysis and Characterization

    Analysis and characterization of protein aggregates: The services provided by our experts include a range of protein aggregation analysis techniques that are used to detect and quantify aggregates in solution in support of formulation development, quality control, stability studies, comparability, releas...
  • Genotoxic Impurities ID and Quantification

    Product Genotoxic Impurities ID and Quantification

    Identification and quantification of genotoxic impurities: To reduce drug safety and quality risks, diagnosing and limiting genotoxic impurities early on in drug development can reduce risk associated with genotoxic impurities. With the implementation of increasingly stringent regulations for impurity leve...
  • Elemental Impurity Testing ICH Q3D

    Product Elemental Impurity Testing ICH Q3D

    Testing for elemental impurities ICH Q3D: To successfully implement ICH Q3D requirements, our experts in elemental impurities and toxicology can help you develop a compliance strategy. We can provide screening studies and data to aid risk assessment, if this does not already exist, or develop and validate ...
  • Pharmaceutical Auditing Services

    Product Pharmaceutical Auditing Services

    Auditing services for the pharmaceutical industry: Our pharmaceutical audits are conducted in accordance with the relevant regulatory texts or standards, including GMP, GDP, GLP, GCP, and GVP. We also audit against IPEC guidelines for Pharmaceutical excipients, ISO 22716 (Cosmetics — Good Manufacturin...
  • Biosimilars Testing Services

    Product Biosimilars Testing Services

    Testing services for biosimilars: Our biosimilar analytical comparability programs provide highly relevant data for early stage characterisation and later stage comparison. These programs evaluate and compare all pertinent features of the biosimilar product and are based on the ICH Q6B. Programs encompass ...
  • Biomarker Assays and Validation

    Product Biomarker Assays and Validation

    Validation of biomarker assays: Our diverse range of analytical platforms supports biomarker analyses including ELISA, flow cytometry, cell-based assays, multiplex ECL platforms, and high sensitivity measurements using QuanterixSimoa HD-X Analyzer™ measurement instruments. Our dedicated biomarker assay te...
  • Liposomal Drug Delivery Technologies Development Support and Analysis

    Product Liposomal Drug Delivery Technologies Development Support and Analysis

    Liposomal drug product characterisation according to the FDA CMC guidance to support your new drug application or biologics license applications. Including: 
    • Physicochemical parameters determined to be CQAs (e.g. particle size, size distribution, zeta-potential and physical stabilit...
  • Biologic Quality Control and Release Testing

    Product Biologic Quality Control and Release Testing

    We deliver responsive QC analysis for complex biologic products from our cGMP laboratories. Our scientists develop and validate methods or perform technology transfer of a sponsor's method for a wide range of analytical methods required for batch release testing. We also routinely carry out testing to Pharmac...
  • Cell-based Neutralization Assays

    Product Cell-based Neutralization Assays

    Experienced cell-based neutralizing antibody assay capabilities. Our experts, at our GLP/GCP compliant laboratory, evaluate each therapeutic, conduct tailored assay development and ensure that each assay is optimized to suitably determine the presence of NAb with maximum possible level of drug tolerance....
  • Vaccine Characterization and Bioanalytical Support

    Product Vaccine Characterization and Bioanalytical Support

    Our vaccines development experts provide a suite of services supporting the analysis and quality control of process and batch release samples and stability studies. We have support the development of a range of vaccines including mRNA, protein, glycoprotein, DNA, carbohydrate, lipopolysaccharide, lipid a...