PHARMACEUTICAL SERVICES Laboratory & Assurance Solutions INTERTEK PHARMACEUTICAL SERVICES Total Quality Assurance for Pharmaceutical Development and Manufacturing Across your product lifecycle, our expertise brings you the insight you need to accelerate pharmaceutical, biopharmaceutical or medical device product development. Our assurance solutions allow you to identify and mitigate risks associated with products, processes, operational and quality management systems, assets and supply chains. Our specialists bring many years of experience across a variety of product areas including: • Innovative and Generic Pharmaceuticals • Orally Inhaled and Nasal Drug Products • Peptides, Proteins • Nutritional Products, Dietary • Biosimilars Supplements • Monoclonal Antibodies • Consumer Healthcare and Cosmetics • Antibody-drug Conjugates • Medical Devices • Oligonucleotide Therapeutics • Veterinary Medicines • Vaccines • Over-the-Counter (OTC) Drugs 2 Achieving Total Quality You can rely on our global network of experts, Assurance laboratories and specialists to deliver support We have delivered flexible including analysis, bioanalysis, formulation Our scientists, regulatory experts and auditors development, biologics characterization, contract services to the work with you at every stage of development specialist inhalation development expertise, global pharmaceutical and manufacturing, providing responsive, regulatory consultancy, risk assessment, quality compliant solutions. auditing and supply chain management industry for over 25 years At Intertek, our wealth of experience and solutions. depth of industry knowledge enables our clients to navigate the challenges of new product development, scale up, manufacturing and market release whilst minimising risks and meeting regulatory criteria accurately. We respond precisely to your needs with solutions that go beyond just “testing” to help you achieve total quality assurance. Laboratory Services Assurance Solutions EARLY STAGE LATE STAGE POST MARKET PRECLINICAL CLINICAL CLINICAL POST APPROVAL SURVEILLANCE & DEVELOPMENT DEVELOPMENT PRODUCTION LABORATORY SERVICES GLP and GCP Bioanalytical Services & Biomarkers GMP and CMC Laboratory Services Pharmaceutical Analysis, Stability and Formulation Development Extractables/Leachables Packaging Support Process Development Analytical Support ASSURANCE SOLUTIONS Toxicology and Impurity Risk Assessment Consulting Product Development Strategies Regulatory Affairs CMC Support & Guidance Toxicology Consultancy Supplier GXP Auditing Solutions, Inspections and Gap Analysis Global Supply Chain Management Solutions & Supply Chain Surveillance Process Quality Audit, Risk Analysis and Process Improvement Environmental Mapping, Inspection and Calibration Process, Facility or Equipment Qualification Sustainability and Asset Integrity Management 3 INTERTEK PHARMACEUTICAL SERVICES Bioanalytical Services With over 20 years of experience conducting regulatory bioanalysis studies, we deliver FDA/EMA compliant bioanalytical solutions that optimise value for your development programs Bioanalysis plays a critical role in the Unique bioanalytical expertise assessment of drug safety and efficacy Our teams are adept in method development, and we understand that each project will method validation and transfer of efficient We apply our bioanalytical present its own unique challenges. Applying and accurate methods which are optimized our 20 years of experience in conducting for your compound. Projects are assigned expertise and industry regulatory bioanalytical studies, our teams to and managed by experienced Principal insight to design strategic work closely with you to ensure that the Investigators with support from teams of best possible solutions are delivered. Project Managers, Project Coordinators, Senior and efficient bioanalytical To help you to make informed decisions Scientists and Chemists. We provide: faster, our Good Laboratory Practice • Bioanalysis for Large and Small Molecules programs (GLP) and Good Clinical Practice (GCP) • Immunogenicity & Neutralizing Antibody compliant laboratories provide clinical Assays kit preparation, sample handling and • Antibody Drug Conjugate (ADC) LC-MS management capabilities, fully integrated and Immunochemistry Services with automated data capture and reporting systems using the latest bioanalytical • Long History of Bioanalytical Support for platforms. Biosimilar Drug Development Our bioanalytical experts have developed • Post Marketing Antidrug Antibody (ADA) methods for thousands of different assays compounds, providing phase-appropriate, • Demonstrated Expertise in Ocular Tissue small molecule and large molecule • Clinical Kit Preparation, Sample Handling & bioanalytical support, high-throughput Management sample bioanalysis, pharmacokinetic, toxicokinetic and pharmacodynamic support, immunogenicity and biomarker assays. Our centres of excellence Our Centre of Excellence in San Diego, CA, USA, spans 46,000 square feet of laboratories, offices and sample storage. Our 30,000 square foot European laboratory is located in Manchester, UK, and together our facilities are positioned to expedite delivery of fast and cost-effective bioanalysis results for global clients. Diverse bioanalytical technologies Our innovative use of technologies means that, no matter how complex your samples, we can accommodate the chemistry or biology of your analytes as well as any matrix interferences. Technologes include immunochemistry, Electrochemiluminescence, GC-MS, LC-MS/MS, qPCR, Nuclear Magnetic Resonance Spectroscopy (NMR), Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) and Surface Plasmon Resonance (SPR). 4 INTERTEK PHARMACEUTICAL SERVICES Large molecule bioanalysis Small molecule LC-MS services CASE STUDY We have extensive experience in the With over 20 years of experience of development, validation, and sample analysis development and validation of quantitative Novel Approaches for An Enzyme of quantitative and qualitative GLP and non- LC-MS/MS methods for novel drugs and Activity Assay regulatory immunoassays in support of clinical metabolites, our scientists deliver robust A client desired an activity assay for a and preclinical studies for therapeutic drugs, and reproducible bioanalysis solutions that PEGylated enzyme for which a commercial synthetic peptides, humanized monoclonal apply validated methods in a high-throughput colorimetric assay was available. The antibodies, chimerics, conjugated drugs, environment to accelerate development colorimetric assay did not meet the growth factors, hormones and cytokines. times for proprietary and generic drugs across performance criteria for regulated work. An many types of biological matrices. We apply immunoassay was then developed but was • Quantitative Ligand Binding Assay regulatory guidelines to a diverse array of subject to significant matrix effects. Capabilities platform technologies including ICP, NMR and • Quantitative ELISAs for Proprietary Our Solution GC. Compounds Development of a replacement assay was • Method Development & Validation complicated by endogenous substrate and • Immunogenicity Studies - High Throughput GLP & GCP Sample enzymatic product.To overcome this, the • Neutralization Cell-based Assay Analysis specificity of LC-MS/MS was employed and Development, Validation and Sample an activity assay developed using a stable Analysis - Pre-clinical & Clinical Bioanalysis labeled substrate which produced a labeled • Radioimmunoassays (RIA), Enzymatic - Bioequivalence & Bioavailability Studies product, which could be differentiated from Assays • Non-GLP Rapid Discovery-Phase the endogenous analyte. • Fluorometric Assays, Luminescence Bioanalysis Benefit Delivered to our Client Assays - In Vitro Screening Bioanalysis A enzymatic activity LC-MS/MS assay was • Biotinylations & Ruthenium Labeling - Tissue Bioanalysis developed and successfully validated to regulatory standards. The method was used • Mode of Action Studies - Early Pharmacokinetic (PK) Studies in multiple pharmacokinetic studies and • Bioanalytical LC-MS/MS for Biologics - Lead Optimization Studies enabled the client to move forward with • Affinity Interactions by SPR • Bioanalysis in Ocular Tissues and Fluids their drug development program. • NMR approaches for PEGylated • Clinical Kit Preparation, Sample Handling & Biomolecules Management • NMR Approaches for PEGylated APIs Biomarker assays • Bioanalysis for trace metals using We deliver discovery and clinical biomarker ICP-MS solutions to support your precision medicine • GC-MS approaches for volatiles strategy enabling you to better predict • Oligonucleotide LC-MS immunochemistry the long-term safety and efficacy of your and immunogenicity. products. Our dedicated biomarker team has expertise in the qualification and validation of biomarkers using ELISA, and ECL platforms (including multiplexing, prototypes and custom multiplexing and Luminex) in multiple matrices and anticoagulants. 5 INTERTEK PHARMACEUTICAL SERVICES GMP and CMC Laboratory Services Through specialist laboratory services for complex products, we help you to accelerate your development process and support your post-marketing requirements Chemistry, manufacturing and controls Stability studies raw material characterisation and sourcing, (CMC) development strategies and Good With a network of ICH stability storage formulation development, scale up, pilot Manufacturing Practice (GMP) laboratory facilities in the UK, USA and Australia, we batch manufacturing and testing, cleaning