For more than 130 years, companies around the world have depended on Intertek to help ensure the quality and safety of their products, processes and systems. We go beyond testing, inspecting and certifying products; we are a Total Quality Assurance provider to industries worldwide. Through our global network of state-of-the-art facilities and industry-leading technical expertise we provide innovative and bespoke Assurance, Testing, Inspection and Certification services to customers. We provide a systemic approach to supporting our customers’ Quality Assurance efforts in each of the areas of their operations including R&D, raw materials sourcing, components suppliers, manufacturing, transportation, distribution and retail channels, and consumer management. Intertek is an industry leader with more than 42,000 employees in 1,000 locations in over 100 countries. We deliver Total Quality Assurance expertise 24 hours a day, 7 days a week with our industry-winning processes and customer-centric culture. Whether your business is local or global, we can help to ensure that your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world. We hold extensive global accreditations, recognitions, and agreements, and our knowledge of and expertise in overcoming regulatory, market, and supply chain hurdles is unrivalled.
GLP and GCP bioanalytical services supporting all phases of drug development and non-GLP rapid discovery phase bioanalysis via state of the art facilities
Intertek Pharmaceutical Services is part of Intertek and has 30 years experience in conducting regulated bioanalytical studies supporting the development of pharmaceuticals, biopharmaceuticals, vaccines and biosimilars. Expert bioanalysis support for both small molecule drugs and biologics is provided through our global network of state-of-the-art, GLP-compliant laboratories located in California, US (San Diego).
Bioanalytical Services for Preclinical and Clinical Studies:
Lead Optimization Studies
Pharmacokinetic (PK) Analysis
Dose Formulation Analysis
Clinical Kit Preparation, Sample Handling and Management
GCP Bioanalytical Services
Bioanalytical Technologies including Liquid Chromatography - Mass Spectrometry, Inductively Coupled Plasma – Mass Spectrometry, Capillary Electrophoresis and Nuclear Magnetic Resonance Spectroscopy
Bioanalysis of PEGylated and other Polymer-Linked Drug Assays
Metals And Elemental Bioanalysis by ICP-MS
Small Molecule Bioanalytical Services:
Quantitative Bioanalytical LC-MS/MS
Rapid Discovery Phase Bioanalysis
Tissue Bioanalysis including expertise in Ocular Tissue Bioanalysis
Large Molecule Bioanalytical Services:
Intertek is a world leading provider of immunochemistry and biomarker services for bioanalytical studies supporting the preclinical and clinical development of protein based therapeutics and other biologic medicines.
Cell-Based Neutralization Assays
Ocular Tissue Bioanalysis
Ocular tissue LC-MS/MS bioanalysis laboratory services supporting ocular drugs preclinical or clinical development
ntertek's ocular tissue LC-MS/MS bioanalysis experience extends over a decade in regard to development and highly optimised validation for a wide variety of compounds in multiple ocular matrices of different species which adhere closely to regulated bioanalysis guidance.
A diverse platform of homogenization and extraction techniques is available for processing ocular tissues and fluids to ensure optimal recovery of analytes. Technologies such as multi-tube bead homogenization and high energy ultrasonication are often employed individually, or in conjunction with more traditional processing techniques.
Non-GLP studies are also routinely conducted to support discovery, lead optimization and proof of concept programs of ocular drugs.
Methods have been validated in the following ocular matrices:
Iris ciliary body
Liquid chromatography - high resolution accurate mass spectrometry (LC-HRMS) protein analysis
Protein analysis, including use of LC-HRMS, is central to drug development and biomedical sciences. Proteins are indispensable to all biomedical systems, being the functional products of the genes that encode them.
Accurate protein identification, quantification and quality assessment is challenging. Reliable protein analysis must yield high sensitivity, broad dynamic range, and accuracy. Some tools for protein analysis suffer from weaknesses that compromise studies in biomedical / drug development studies. However, LC-HRMS can quantitatively solve problems in protein analysis, with depth and accuracy, including assessment of the quality attributes of protein therapeutics.
Intertek Pharmaceutical Services has the necessary instrumentation, software and personnel required for state-of-the-art protein analysis by LC-HRMS. We offer LC-HRMS services for essentially any protein analysis project at any scale. We employ state-of-the-art mass spectrometers, which deliver the highest quality data.
Notably, Orbitraps at Intertek are qualified for regulatory compliance, which is rare and valuable. We have decades of collective experience in LC-HRMS protein analysis, advising clients on the most practical, punctual path forward, and implementing win-win agreements. Moreover, we have collaborative immunochemistry and cell-based assay expertise under the same roof, seamlessly serving diverse bioanalytical needs at one site.
Intertek’s innovative pharmaceutical services and global network of laboratories and specialists offer a level of assurance, testing, inspection and certification support, helping to bring quality and safety to life for our customers.
The value we offer research teams is noted below:
Clinical sample handling and kit logistics services aligned with client requirements for efficient bioanalytical programs integrated with bioanalysis laboratory services.
Intertek offers comprehensive clinical sample handling and kit logistics services that are crucial for maintaining the integrity of pharmaceutical samples. This process includes collecting, processing, packaging and shipping samples for our clients, providing support across an entire study and offering a fast and efficient path to market.
When submitting samples for analysis, certain protocols and methods must be followed to comply with regulatory standards. Pharmaceutical companies can find it challenging to ensure the proper procedures have been followed for collecting, packaging and shipping samples to the testing site. If the correct procedures are not implemented, samples may be compromised in transit resulting in a sample that can no longer be analyzed.
Our staff of dedicated, highly-trained professionals provide a customized approach and quality support services, with materials designed specifically for each clinical study. Through the development of study specific sampling manuals, sample collection kits, shipping kits and additional materials, we provide assurance that procedures are carried out in accordance with the study protocol, applicable regulations and validated methods.
Our services include:
Quality support designed specifically for each clinical study and coordinated with our bioanalytical laboratory
Specialization in domestic and international cold chain logistics for samples from multi-site studies
Trained staff that develops everything from study specific sampling manuals to detailed labels to ensure that FDA/GLP/OECD regulatory compliance is met
Exceptional quality at extremely competitive rates
Integration with bioanalysis laboratory services
Sample Collection Laboratory Manual
The laboratory manual is specifically designed for each study protocol and includes all the instructions and documents required for notification, sampling, storage and shipment of samples from the collection site to the analytical site. The manual contains:
Collection and processing of samples
Sample shipment instructions
Robust and reliable packing and shipping materials ensure your samples will maintain appropriate conditions throughout transport. The materials included are:
DOT required labels
Coordination and delivery of dry-ice
Coordination of shipping (both domestic and international)
Access to preferred logistics carriers
Sample Collection Kits
Sample collection kits are designed for each client’s specific needs. Kits can be generic, patient specific, or interval specific. If a study requires a specialty collection tube containing additional additives or stabilizers, then these tubes can be included in the kits. All kits include:
Sample collection tubes
Study specific labels
Matrix collection sheets
Training and On-Call Support
Intertek provides staff training for sample handling and management, including the laboratory manual and kit preparation at each clinical site. If required, a 24-hour on-call service can also be provided at an additional hourly rate.
Intertek’s pharmaceutical labs are located around the globe, providing convenience and peace of mind to our clients. This worldwide reach provides total quality assurance for small, mid-size, and large pharmaceutical companies.
Semi-quantitative and quantitative protein and bioanalytical LC-MS/MS services for developing and validating complex methods
LC-MS studies can contribute important data to support preclinical and clinical drug development.
Our scientists, located at our GLP Bioanalytical Center of Excellence in San Diego, California, USA, have extensive experience in the development, validation and sample analysis of bioanalytical LC-MS assays for parent drug and metabolites in a large variety of biological matrices for both preclinical and clinical programs.
Our LC-MS teams are specialists in the conduct of US FDA Good Laboratory Practice (GLP) compliant studies.
We also perform non-GLP / discovery LC-MS assays on large and small molecules. Combined with automated data capture and reporting systems, this has established our laboratory as a leading center of excellence for bioanalysis in North America. Capabilities include high throughput sample analysis, non-GLP rapid discovery phase bioanalysis, diverse types of protein LC-MS analysis using high-resolution / accurate mass (HRMS) instrumentation, clinical pharmacokinetics (PK), and toxicokinetics (TK) support, as well as specialized bioanalysis for ocular and other tissues. Core expertise includes developing and validating methods that are robust and reproducible, and employing these methods in a high throughput environment to accelerate development times for prescription medicines (Rx drugs) and generics.
Our laboratory is FDA inspected and GLP-compliant.
LC-MS Bioanalysis Services:
Rapid Discovery Phase Bioanalysis
Ocular Tissue Bioanalysis
Sample Handling and Management
Protein Analysis using LC-HRAMS
Immunogenicity assays for detection of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) in support of nonclinical and clinical studies
Immunogenicity assays are integral to biologic drug development. Biotherapeutics, such as proteins, antibodies, conjugated peptides or oligonucleotides can induce an immune response in the body, leading to the development of anti-drug antibodies (ADAs). The neutralizing fraction of ADA (NAb) may not only decrease the therapeutic activity but can potentially threaten patient safety. Assessment of immunogenicity, i.e. formation and persistence of ADA and NAb is a fundamental and crucial part of drug development.
Immunogenicity Assessment Services:
Development and validation of qualitative and quasi-quantitative assays for total antibody detection. Formats utilize a three-tier approach (screen, confirmatory/specificity, then titer) that includes statistical cut-point analysis
Multiple assay formats available: direct or bridging ELISA, direct or bridging ECL
Approaches to increase drug tolerance: MSD Bridging Mastermix with acid dissociation, ECL/ELISA based Solid phase extraction with acid dissociation (SPEAD), Affinity Capture Elution (ACE), “BEAD” (use of nanoparticles or magnetic beads) assays
Development and validation of cell-based assays, receptor binding assays or competitive ligand binding assays for detection of neutralizing antibodies
Integration of pharmacokinetic (PK) and immunogenicity results in animal and human studies
Expert immunogenicity Strategy, Design and Implementation
With Intertek, you gain an experienced partner who is knowledgeable in developing immunogenicity programs. Each project presents its own unique set of challenges, and our Principal Investigators and Scientists will work closely with you to ensure that your assays are properly developed and validated to meet all regulatory requirements. Through efficient management and proactive communication, we will help you to achieve your immunogenicity testing goals over your product’s development lifecycle.
Immunochemistry services including development, validation and analysis supporting toxicokinetics (TK), pharmacokinetics (PK), immunogenicity and biomarker studies
Immunochemistry, or large molecule bioanalysis, is necessary to gain data on product efficacy, safety, disease state or mechanism of action, which will allow you to make informed and important decisions during biologic drug development.
Our immunochemistry experts provide this support through immunoassays, ligand binding assays supporting toxicokinetics (TK) and pharmacokinetics (PK) studies, immunogenicity and biomarker studies. Our scientists have extensive experience in the development, validation, and quantitative or qualitative Good Laboratory Practice (GLP)/non-GLP immunoassays in support of clinical and preclinical studies.
Our industry-leading immunochemistry expertise includes developing and validating proprietary assays, implementing and validating existing methods, optimizing methods then validating, and also validating existing immunoassay kits (ELISA and ECL platforms).
Founded in 1999, our US center of excellence is located in San Diego, California. The facility is GLP compliant and inspected by the FDA. Our GLP European facility is located in Manchester, UK.
With over 20 years’ experience in large molecule bioanalysis, our experts are thought leaders in the immunochemistry community with a strong knowledge of the regulatory guidance and scientific background. Our GLP compliant laboratories are equipped with the latest technology for immunoassay development such as quantitative ligand or receptor binding assays or immunoassays for use in pharmacokinetic (PK) and toxicokinetic (TK) studies. Our scientists regularly work with clients from all around the world, on a range of product types including monoclonal antibodies, antibodies-drug conjugates, growth factors, hormones and cytokines.
Intertek Pharmaceutical Services provides customized Small Molecule, Large Molecule, Peptide, ADC and Biomarker analysis in a Fit-for-Purpose regulatory environment through combining state of the art instrumentation with extensive scientific, logistical and regulatory knowledge.
LC - Extensive list of pre-validated methods accumulated over 25 years of supporting clients in Exploratory and Clinical settings.
High Resolution MS - Validated methods for whole protein MS analysis.
Ligand Binding PK - Deep experience with Method Development and Validation results in solid methods increasing sample pass-rates and reducing cost over-runs.
ADA - Extensive experience with MAbs, Fabs, Growth Factors and Peptides ensures efficient method development and solid assay performance during sample analysis phase.
NAb - Cell based group with a history of developing novel solutions combined with a strong understanding of statistical analysis ensure methods limit data ambiguity.
Intertek Pharmaceutical Services has routinely supported clients in validating the utility of specific PD Biomarkers through combining extensive knowledge in Immunoassay Development and Validation and use of the most optimal platform to meet client needs.
Fit-for-Purpose Biomarker Analysis for support of Small Molecules, Peptides and Large Molecules using a variety of Platforms including LC, LC-MS, ELISA, Radioimmunoassay (RIA), Electrochemiluminescence (MSD), Luminex, Flow Cytometry.
Our dedicated biomarker assay team have validated a range of biomarker assays using enzyme-linked immunosorbent assay (ELISA) and electrochemiluminescence (ECL) platforms. The assays include both singleplex and multiplex platforms in multiple matrices, such as plasma, serum, cerebrospinal fluid (CSF) for use in Good Laboratory Practice (GLP) compliant preclinical and clinical development programs.
With our experience in using biomarkers as surrogate endpoints in clinical research for disease states including metabolic, inflammatory, CNS, and cardiac, we can help you to obtain interim evidence about the safety and efficacy of therapeutic treatments. Our experts have the knowledge necessary to interpret results, providing insight into the drug response. The data from these studies can help you to design smaller, more efficient studies, reducing the number of subjects and shortening the time to approval of new treatments.
By selecting Intertek, you gain a partner with extensive experience in biomarker assays. Our center of excellence, founded in 1999 located in San Diego, California, USA, is recognized as one of the leading biomarker assay laboratories in the world. Through close collaboration with MSD over the years, we have gained significant knowledge in validating a wide range of multiplex biomarkers (V-PlexTM). To support your global clinical development programs, we offer bioanalysis and biomarker expertise from our center of excellence in San Diego and our European GLP/GCP facility based in Manchester, UK.
Experienced cell-based neutralizing antibody assay capabilities
Our experts, based in Good Laboratory Practice (GLP) compliant laboratories, 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. Assay development and optimization are performed through careful selection of proper cell line, assay format, and positive control NAb, optimization of assay parameters, sample dilution or pretreatment, if necessary, and meticulous data processing and statistical analysis. Variety of assay formats can be implemented, including but not limited to Cell Proliferation, Viability, Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC), Complement-Dependent Cytotoxicity (CDC), Cytopathic Effect Inhibition (CPE), Apoptosis, Ligand Stimulated Cell Signaling, Enzyme Activity, Reporter Gene Assays, Protein Secretion, Metabolic Activity, Stress and Mitochondrial Function. Detection readouts include Absorbance, Fluorescence, Luminescence, Chemiluminescence, or Flow Cytometry.
Through the intelligent and experienced application of cell-based neutralizing antibody assays, Intertek is the ideal partner for your biologic drug development or pharmacovigilance requirements for immunogenicity testing. Our immunogenicity experts, who are considered thought-leaders in the large molecule bioanalysis community, have worked on thousands of biologic drugs helping global clients understand the safety and efficacy of their products.
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