Biomarker Assays and Validation

Biomarker Assays and Validation
Product Description

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 team have validated a range of biomarker assays for many matrices such as plasma, serum, cerebrospinal fluid (CSF) for use in GLP/GCP 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.

To learn more, visit our website:

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
  • 1000 - 4999
Company types
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
  • Supplied from
    United Kingdom

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
  • 1000 - 4999
Company types
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain

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Intertek Analytical Services resources (48)

  • News Boosting in Vitro Testing for Nasal Drug Products

    In Vitro Test Methods for Nasal Drug Products VIDEO: Learn how our Alberta Idealised Nasal Inlet (AINI) capability can deliver enhanced IVBE studies for generics and support the development of novel intranasal products targeting specific nasal regions 
  • Brochure Brochure - Pharmaceutical Services

    Covering our full breadth of contract laboratory services, auditing and regulatory consultancy expertise, this brochures provides a summary of our global capabilities.
    Visit for more information.
  • Sponsored Content Intertek’s Pharmaceutical Audit Services Team celebrates 15 years of excellence

    Celebrating 15 years of delivering flexible auditing solutions for the global healthcare, pharmaceutical, and cosmetics sectors, our Pharmaceutical Audit Services Team have continually innovated to build a set of relevant auditing services to help clients meet the evolving challenges of driving quality and visibility across complex global supply chains.

  • Brochure Brochure - Inhalation Drug Product Development Expertise

    Our inhalation product experts have been working in the inhaled and nasal fields for nearly 30 years and possess the necessary experience to help design, implement and support full development, stability and testing services which are designed to provide the right information at the right time. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
  • News The Vaccine and Therapeutics Development Digital Resources Have Been Released

    Our library of digital resources is available to enhance your knowledge-base and educate you along every step of the drug development process. Keep up-to-date with industry hot topics and the latest research developed by our thought-leaders. 
  • Brochure Poster - Top 5 Considerations for Outsourcing Stability Storage

    Intertek Melbourn have provided GMP stability storage services since 2004. Our Stability team are currently coordinating over 200 stability studies for more than different 30 clients from across all global territories. We offer over 375,000L of capacity over various conditions, including ICH and bespoke conditions.
  • News Expansion in characterisation and development support for mRNA vaccines and therapeutics.

    Intertek Pharmaceutical Services has expanded laboratories services supporting mRNA vaccine and therapeutic products. At our GLP / GCP / GMP laboratories, scientists can test mRNA drug substance or drug products to help you confidently assess batch to batch manufacture and process repeatability as well as the quality of mRNA. Additionally, our experts provide mRNA specific methods including integrity, potency, capping efficiency, residual DNA template, residual dsRNA and delivery system testing. 
  • Brochure Poster - Flexible Outsourcing Solutions, Laboratory Services

    Our team support you across your development and production lifecycle including cGMP and GLP/GCP compliant characterization, stability, release testing and bioanalysis. You will need a strategic partner who invests in scientific and technical excellence to help you to develop and launch a pipeline of new products that meet the needs of patients, buyers and consumers.
  • News Intertek expands pharmaceutical services to expedite clients’ biologics and gene therapy development

    A new facility, currently being commissioned, to bring increased capacity for contract lab services for clients developing biologics and gene therapies. Expanded footprint and capabilities include temperature-controlled laboratories, leading-edge analytical technologies with recruitment of over 60 additional scientists, statisticians and regulatory project managers.
  • Brochure Brochure - Oligonucleotide Analytical Development Services

    Our scientists have supported oligo medicine drug development since the inception of this class of therapeutics. Through our dedicated suite of characterisation techniques we are focused on helping you to meet industry requirements for regulatory compliant (GMP or GLP) characterisation and quality control for oligonucleotide based drugs. Bringing quality and safety to life, our Total Quality Assurance expertise is delivered consistently to help you ensure you meet and exceed your quality, safety and efficacy requirements. 
  • Brochure Brochure - Biopharmaceutical Analytical Development Support

    We have nearly 30 years of experience in biopharmaceutical development support across a wide range of product types, including proteins, monoclonal antibodies, vaccines, PEGylated proteins, antibody drug conjugates, peptides, cytokines (e.g., interferons), oligonucleotides, glycoproteins, and biosimilars. With broad capabilities in Europe and North America, our Total Quality Assurance expertise is delivered consistently to help you meet and exceed your quality, safety, and efficacy requirements. Intertek's experts provide strong scientific and technical leadership, coupled with project management and regulatory support, to drive your development and manufacturing programs forward.
  • Brochure Brochure - Bioanalysis Services

    Bioanalysis plays a critical role in the assessment of drug safety and efficacy. We understand that each project presents its unique challenges, and by applying our nearly 30 years of experience in conducting regulatory bioanalytical studies, our teams work closely with you to ensure that the best possible solutions are delivered, optimizing value for your programs. With Intertek as your partner, you have access to the scientific and regulatory knowledge of our bioanalytical experts, so that you can leverage the insight we bring to accelerate your drug development.
  • Brochure Brochure - mRNA Vaccine & Therapeutic Products Analytical Development Services

    By integrating advanced analytical technology with a heritage supporting pharmaceutical product development, our experts offer Total Quality Assurance to help you ensure the safety, efficacy, and quality of your mRNA therapy.
  • Brochure GLP/GCP Bioanalytical Services

    Bioanalytical Expertise from Preclinical to Commercialisation
  • Technical Data Factsheet - ATMP Analytical Development Services

    The complexity of Advanced Therapy Medicinal Products (ATMPs)  and their mode of action, present many challenges to development. Our experts provide analytical development and routine testing to help you meet regulatory expectations for safety and efficacy. 
  • Technical Data Factsheet - Biomarker Services

    Fit-for-purpose solutions for exploratory and confirmatory biomarkers.
  • Whitepaper Whitepaper - Stability Studies Across the Drug Product Lifecycle

    Stability studies play a fundamental role across the lifecycle of pharmaceutical products to demonstrate that a new drug substance or drug product is within acceptable chemical and physical limits.

    A host of considerations must be incorporated into the study design at the outset, with many variables that depend on the product type, the development phase, and the region that the product will be marketed in. In this paper, Tasmina Bokhari, Stability Team Leader, provides a review of the role stability studies play across the product development process.

    Download whitepaper:

  • Whitepaper Whitepaper - Quality Control of Oligonucleotide Therapeutics

    In this whitepaper, our oligonucleotide services experts describe analytical approaches to achieve identification and and characterisation including melting temperature determination, structural characterisation using NMR and high resolution mass spectrometry and determination of product or process related impurities.

  • Whitepaper Whitepaper - Evaluating Properties of Liposomes

    In this whitepaper our expert, describes analytical approaches to evaluate the physicochemical properties of liposomes for drug delivery systems according to the FDA Guidance for Liposome Drug Products.
  • Whitepaper Whitepaper - Monitoring of Glycosylation Analytical Approaches for Antibody-Based Therapeutics

    An introduction to N-linked glycosylation and available approaches for characterization.

    N-linked glycosylation is a common post-translational modification on many antibody-based therapeutics, and has been linked to safety, stability and activity. Glycosylation should therefore be monitored and controlled.

    In this white paper, our expert Michael Walker discusses complementary N-linked glycosylation characterization techniques that give relative levels of different glycoforms at specific sites and compares them to more common methodologies of enzymatic stripping and fluorescent labelling.

    Download whitepaper:
  • Whitepaper Article - Addressing Key Attributes of Viral Vectors

    In this article our expert describes key considerations for the characterization of viral vectors including a case study focusing on the determination of empty vs full capsids.

  • Whitepaper Whitepaper - GMP Flow Cytometry

    In this whitepaper our expert describes the applications, considerations and challenges of utilizing Flow Cytometry techniques in a regulatory environment.
  • Whitepaper Article - A Strategic Approach to Nitrosamine Screening in Drug Products

    In this article our expert describes a strategy for screening nitrosamines that delivers clear and accurate results and avoids false positives, by applying both LC-MS/MS and HRMS techniques.

  • Whitepaper EBook - Flexible Contingency Outsourcing Solutions

    In this e-book, our expert looks at how a partnership with an experienced CRO can enable your business continuity through flexible analytical laboratory solutions with a focus on efficient method transfer.

  • Whitepaper Article - CMC Considerations for mRNA Based Therapeutics

    This article discusses analytical approaches to characterise mRNA in early-stage development to support effective therapeutic programs.
  • Whitepaper Article - New Approaches to Bioassay Design

    In this article our expert describes new approaches to study design that lead to reliable, more robust cell potency assays.
  • Whitepaper Article - Challenges in mAb Characterisation

    In this article our experts describe the challenges which must be overcome when characterizing monoclonal antibodies in a GMP environment.
  • Whitepaper Article - Characterisation of Bispecifics

    In this article our experts describe key considerations for the characterisation of bispecific antibodies.
  • Whitepaper Whitepaper - Repurposing Vaccines for Intranasal Development

    Repurposing Vaccines for Intranasal Development
    Benefits, Challenges and Considerations For a Non-Invasive Yet Effective Delivery

    Intranasal vaccination offers significant benefits including ease of administration, and the potential induction of mucosal-specific as well as systemic immunity. Liquid and dry powder formulations can be delivered by intranasal routes. Challenges to development though, are posed by inefficient absorption, low permeability of the nasal tissues for high molecular weight therapeutics, and rapid mucociliary clearance, amongst others.In this article, Mark Parry, Technical Director, describes the challenges to intranasal delivery with a focus on how strategic formulation and device selection for mucosal vaccine delivery can help overcome development challenges.
    Download whitepaper:
  • Whitepaper WHITEPAPER - Download: Extractables and Leachables Strategies for Pharmaceutical Production Tubing

    In order to mitigate the risks of potentially harmful substances leaching from contact materials or process tubing into a medicinal/pharmaceutical product which may present a health risk to the patient, a robust approach to extractables and leachables (E&L) studies is required in order to gain a good understanding of the materials in the tubing products. In this short article, our expert, Dr Tino Otte, Senior Scientific Consultant, describes the steps of a rigorous E&L study that can be taken to ensure safe and high-quality materials and tubing products
  • Whitepaper Article - Overcoming Challenges to Inhaled Biologic Development

    The significance and challenges of delivering a biologic drug to the lungs and the nose.
    Inhaled biologics have been forecast to grow in importance due to the fact that inhalation presents a highly attractive route for the administration of various classes of large molecule, particularly for the treatment of respiratory diseases. Here, Chris Vernall, Business Development Director, Intertek Pharmaceutical Services, discusses the significance and difficulties of biologics in the inhalables sector, and how Intertek’s Centre of Excellence for Inhaled and Nasal Biologics provides valuable services for those developing products in this area.

  • Whitepaper Article - Nebulised Drug Development Considerations

    Nebuliser delivery of drugs offers a patient-friendly means of transforming a medicine into a breathable aerosol. They offer the advantage, over other types of inhaled device (such as pMDIs or DPIs), in that they do not require such strict patient coordination between inhalation and actuation, and so they are effective for the treatment of paediatric, elderly, ventilated and sedated patients.
    Intertek Melbourn have been supporting clients’ product development for nearly 30 years across all classes of inhaled and nasal delivery technologies including nebulised therapeutics. In this bite-sized article our Formulation and Manufacturing Lead, David Ward, shares some considerations for successful development of nebulised drugs.
  • Whitepaper Article - In Vitro Bioequivalence for Pulmonary and Nasal Delivery

    With a focus on bioequivalence testing in the development of generic inhalables, Mark Parry, Technical Director, Intertek Melbourn, highlights some of the shortcomings of aerodynamic particle size distribution and delivered dose testing, and introduces newer testing techniques that Intertek offers to allow its clients to de-risk clinical studies or even to support robustly in vitro data submissions as to avoid clinical work.
  • Whitepaper Whitepaper - Glass Delamination Studies for Pharmaceutical Vials

     The phenomenon of glass delamination is a serious quality issue. Delamination is characterised by the formation of small glass flakes, also known as lamellae, which are shed from the internal surface of the glass container, pH changes and extraction of ions from the glass material leaching into the product – all of which have significant potential to compromise product quality whilst also compromising the overall glass structure.

    This white paper summarises testing approaches (such as USP<1660>), predictive screening studies, interaction studies, leaching experiments and microscopy investigations which can help to mitigate the risks which glass delamination pose to product quality and patient safety.
  • Whitepaper Whitepaper - Extractables and Leachables Strategies for Transdermal Delivery Patch Products

    Transdermal delivery patches often contain multiple materials, adhesives and inks which increase the risk of unwanted leaching of potentially harmful substances from these materials. Such substances may penetrate the skin barrier and into the patient. For this reason, strategically designed extractables and leachables (E&L) studies are of critical importance to the development of transdermal delivery products.
    In this application note, Dr Tino Otte, Senior Scientific Consultant, Intertek Reinach, describes the steps required to implement and adapt an E&L study design for a transdermal delivery patch device.
  • Whitepaper Strategic Partnerships with Contract Lab Services Organizations

    We describe the critical attributes required for a successful strategic partnership between a Contract Laboratory Organisation and sponsor and the benefits that this approach can yield. Download now to learn from our experts.
  • Whitepaper Intranasal Delivery of Biologic Therapeutics

    We look at how the nasal route of drug administration offers the potential to improve delivery of biologics and why strategic formulation is required to make this a reality.
  • Video VIDEO - Cell and Gene Therapy Analytical Development Services

    Intertek's cell and gene therapy experts provide analytical development to help you meet regulatory expectations for safety and efficacy of your products. Cell and gene therapies are complex medicines for human use that are based on genes, tissues or cells. In addition, these may be incorporated into a delivery technology or a medical device. The wide variety of products within this category and their inherent complexity means that each will present different analytical development challenges and so specific characterisation, potency, purity and identity assays are required for each product. 
    Learn more:
  • Video WEBINAR - Translating Inhaled and Nasal Technologies for the Delivery of Biologics

    Inhaled and nasal delivery platforms have specific applications outside of their traditional uses for asthma/chronic obstructive pulmonary disease (COPD) and seasonal rhinitis/sinusitis: They can offer real advantages for the delivery of therapeutic biologics. During this short presentation, Intertek's Technical Director, Mark Parry, will provide an overview of currently available technologies and successfully marketed products, with a look at the development challenges that might be encountered — and the solutions that are available — when formulating these delivery routes. Mark will also describe key considerations when rapidly repurposing existing products for inhaled delivery.
  • Video WEBINAR - Design of Robust Extractables and Leachables Studies

    To ensure patient safety, precise knowledge about potential contamination associated with a drug product container closure systems (CCS) or single use process equipment is critical. As the complexity of materials and construction of CCS or process equipment increases, the risk of leachables being introduced as drug impurities increases significantly. Authorities are focused on accurate determination of leachables present in the real drug matrix and this demands the need for sensitive and robust analytical effort and interpretation of complicated complicates data.
    During this presentation, our expert, Dr Tino Otte, Head Consulting at Intertek in Switzerland, focuses on how to design a robust extractables and leachables study design which covers all necessary steps to meet regulatory expectations whilst highlighting potential challenges of such a study with strategies and examples of how to address these challenges.
  • Video VIDEO - GMP Cryo-TEM Services

    This video describes Intertek's GMP Cryo-TEM Services supporting the development of safe and effective advanced therapies.
  • Video WEBINAR - Extractables and Leachables Studies for Process Materials and Container Closure Systems

    In this webinar, our expert, Dr Tino Otte, Head Consulting at Intertek in Switzerland, discuss extractables and leachables studies which have been performed on multiple product types and contact materials. With increasing focus by the authorities on the accurate determination of leachables in real formulations, one of the biggest challenges is to differentiate between matrix related degradation products and real leachables from the packaging or contact materials. Typical examples and case studies will illustrate how, through a strategic approach, it is possible to differentiate between the two. Furthermore, these case studies will illustrate why it is important to analyse leachables in the actual formulation and not only in extraction solutions.
  • Video WEBINAR - Analytical Approaches for Identification and Quantification of Impurities In Pharmaceuticals

    The characterization and quantification of impurities in pharmaceutical products is a critical part of quality control. In many cases, routine analysis techniques are not sufficient to fully characterize the impurity profile due to overlapping of peaks, low peak intensity or inaccurate mass detection. Even if the correct molar mass of a compound is known, multiple structures are still possible and the real concentration often cannot be detected due to absence of chemically similar standards. In this webinar, our expert speaker Sandro Laiso we will highlight different approaches to characterize impurities in pharmaceutical products, step by step, making use of unique combinations of analytical techniques such as PRE-LC, HR-MS or qNMR. 
  • Video WEBINAR - Repurposing Products for Inhaled Delivery - Rapid Response Strategies

    Delivery to the lungs is important for COVID-19 and there is currently an unprecedented need to accelerate development of effective therapies and vaccines. There is a focus on repurposing existing candidates as a strategic route to get the products to patients faster, however, many candidates are not yet in a format suitable for delivery to the lungs. Redevelopment must be fast, effective and accurate with tight control over quality in order to get a drug ready for clinical trials. In this webinar, Mark Parry, Technical Director, Intertek Melbourn, describes the strategies required for rapid repurposing for inhaled delivery, discussing considerations whilst mitigating anticipated challenges.
  • Video VIDEO - Analysis and Characterization of mRNAs for Therapeutic and Vaccine Development

    Development of Next-Generation of mRNA-Based Vaccines & Therapeutics: With a combination of state-of-the-art analytical technology and a long history of working with advanced pharmaceutical development, our experts in Total Quality Assurance assist you in the drug development process. Get in touch with us today to learn how we can help you ensure the quality, efficacy, and safety of your mRNA therapy.
  • Video WEBINAR - Characterization and quantification of known & unknown substances by NMR

    Structure elucidation and quantification of unknown species is one of the biggest challenges during development of analytical methods for routine quality control. The advantage of the NMR is the relatively simple and robust sample preparation combined with unique selectivity which often differs from those of chromatographic techniques. In many cases, matrix components and target species will show NMR signals with opposite shifts which enables the characterization of the targets directly in the sample mixture. In this webinar, we will explain how quantitative NMR can be used as a powerful tool for characterization of isolated unknowns or even complex mixtures of different compounds. Our expert will explain the advantages of the NMR method in detail with typical examples from routine analysis.
  • Video WEBINAR - Biocompatibility - The Importance of Extractables & Leachables Testing

    To ensure patient safety, precise knowledge about potential contamination associated with medical device materials is critical. For this reason, a robust chemical characterization is the first and mandatory step of any biocompatibility study which is performed according to the most recent version of the ISO 10993 guidance. With increasing complexity of medical devices and combination products, the risk of leachables being introduced into the body increases significantly. Depending on the type/class of device, application scenario and contact time, extractables and leachable studies can be divided in different sub-steps to build a comprehensive understanding of the related risks. 
    During this webinar, our expert, Dr Tino Otte, Head Consulting at Intertek in Switzerland, will provide an analytical strategy for e/l screenings with a focus on the problems which may occur when targets above the analytical evaluation threshold are detected.