8
Oct
2024
Intertek Pharmaceutical Services
Exhibitor at CPHI Milan 2024 stand 5D106, Contract Manufacturing and Services
About Us
Categories
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GB -
2015On CPHI since
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4Certificates
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1000 - 4999Employees
Company types
Primary activities
Contact info
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Intertek Pharmaceutical Services, Hexagon Tower, Crumpsall Vale. off Delaunays Road, M9 8GQ, Manchester, United Kingdom
Event information
CPHI Milan 2024
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08 Oct 2024 - 10 Oct 2024
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Fiera Milano, Italy
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Visit us at stand 5D106, Contract Manufacturing and Services
Products Featured at CPHI Milan 2024
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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 ... -
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... -
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... -
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 locatio... -
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 s... -
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 r... -
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... -
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 int... -
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 t... -
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) laborato... -
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>, &l... -
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 clin... -
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 Manufacturin... -
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 ac... -
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, ... -
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 a... -
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, ... -
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 manufa... -
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)... -
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 distributio... -
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, rel... -
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 l... -
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 valida... -
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 Manufactu... -
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 encompa... -
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... -
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 stabi... -
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 Phar... -
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 toleran... -
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, lipi...
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