Elemental Analysis and Trace Metals (ICH Q3D, USP 233/232)

Elemental Analysis and Trace Metals (ICH Q3D, USP 233/232)
Product Description

We provide pharmaceutical organic and inorganic elemental analysis from trace levels to percent levels. Trace metals testing is a routine activity for our Good Manufacturing Practice (GMP) laboratories and is carried out in accordance with pharmacopeia methods such as the United States Pharmacopeia (USP) Chapters USP 232 and USP 233  for elemental impurities or to client specific methods. We also provide combined toxicological risk-assessment and testing compliance services to meet the requirements of ICH Q3D Guidelines for Elemental Impurities.

Our experienced analysts apply a strategic approach to sample preparation for difficult samples and a range of analytical technology, relevant to your needs, including inductively coupled plasma – mass spectrometry (ICP-MS) or inductively coupled plasma – optical emission spectroscopy (ICP-OES), ion chromatography (IC), flame atomic absorption spectroscopy (FLAA) and X-ray fluorescence (XRF).

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Intertek Pharmaceutical Services

  • GB
  • 2015
    On CPhI since
  • 4
Contract Service
  • Supplied from
    Switzerland; United Kingdom; United States

Intertek Pharmaceutical Services

  • GB
  • 2015
    On CPhI since
  • 4
Contract Service

More Products from Intertek Pharmaceutical Services

  • 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 stage of the development process, you can expect high-quality, flexible services that give you an advantage in the fast-moving marketplace. For over 30 years, our network of Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or Good Manufacturing Practice (cGMP) laboratories, auditors and regulatory experts have provided high quality technical services – ensuring Total Quality Assurance for some of the world's largest and most innovative pharmaceutical companies. We offer services such as GMP and CMC support, formulation and analysis for biopharmaceutical development, inhaled and nasal drug development, analytical services, stability testing and storage, bioanalysis, audits, and consulting.

    Find out more: www.intertek.com/pharmaceutical
  • 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, heterogeneity, aggregation/biophysical characteristics, potency, stability, and impurities. In addition to our expertise in orthogonal protein analysis (GLP/GMP), our scientists address key molecular and biological characteristics (ICH Q6B) such as protein quantity, characteristics, the degree of heterogeneity within samples, and structural information of a biomolecule – including post-translational modifications (PTM), glycosylation, higher-order structure and assessment of aggregation or degradation. These help you establish Critical Quality Attributes (CQAs) for your products and QC programs. Our expertise also includes drug delivery technologies for biologics, such as inhaled and nasal delivery.

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  • 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 support for NDAs and ANDAs, and clinical trial manufacturing services.

    We can help you with method development, method validation, inhalation product analysis, comparator studies, device/excipient compatibility studies, quality by design (QbD), formulation development, clinical trials, and materials manufacturing, as well as product characterization.

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  • 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. We have 24-hour alarm systems at all sites with dedicated teams on call to respond to excursions from storage conditions and over 375000L of storage capacity. We provide storage only or real-time or accelerated stability testing integrated with our analytical method development and validation and release testing teams.

    In addition to providing professional stability management for outsourced storage, we can offer good manufacturing practice (cGMP) stability programs for the most complex dosage forms including oral inhaled and nasal drug products (OINDP), biopharmaceuticals, consumer healthcare, medical devices, and vaccines. Also, we provide a responsive and tailored stability contingency and disaster recovery storage service, which reduces the risk of costly stability trials.

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  • 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 studies, extractables and leachables, solid-state characterization, cGMP quality control testing, and cGMP batch release testing.

    Our teams have expertise with complex medicines and drug delivery systems such as inhalation drug product development for pulmonary and nasal products – or complex medicines such as peptides, monoclonal antibodies, proteins, oligonucleotides, mRNA, vaccines, and gene therapies.

    Find out more: www.intertek.com/pharmaceutical/gmp-cmc-laboratory
  • 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 achieve excellent LOD and LOQ values over a variety of techniques. This helps to mitigate issues such as instances of LC co-elution of NDMA and DMF, as well as other potential interferences, where present. This flexibility in platform approaches means we can apply sample and nitrosamine-specific, tailored analytical solutions that are highly relevant for your nitrosamine testing needs.

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  • 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 the development of pharmaceuticals, biopharmaceuticals, vaccines, and biosimilars by regulated bioanalytical studies, including the following:

    - Method Development
    - Method Validation
    - Lead Optimization Studies
    - Pharmacokinetic (PK) Analysis
    - Bioavailability Studies
    - Bioequivalence Studies
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    - GCP Bioanalytical Services
    - Bioanalytical Technologies
    - Bioanalysis of PEGylated and other Polymer-Linked Drug Assays
    - Metals and Elemental Bioanalysis by ICP-MS

    Find out more: https://www.intertek.com/pharmaceutical/bioanalysis
  • 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 intended purpose.

    We have expertise across a variety of molecules and formulations, including small molecules, biologics, nanoparticles, solids, patches, gels, ointments, liquids, and inhaled products. Method development, improvement, qualification, validation, transfer, and maintenance related to GMP production are all part of our cost-effective analytical method lifecycle management services. Our integrated approach to the analytical method lifecycle has been deployed in thousands of projects for clients worldwide – to ensure that their methods are best suited for the intended use during the various clinical stages of the commercialization process.

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  • 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 most promising candidates to progress through to clinical development for powders, capsules, liquids and solids, semi-solids, inhaled, nasal, nebulised, pressurised and topical drug formulations.
    We provide focused understanding from an early stage of development tailored to your new chemical entities (NCE) and generic products, from feasibility through to development support, Phase I and Phase II clinical trials, scale-up and transfer to commercial manufacturing. Our strengths in orally inhaled and nasal drug product development help you to overcome challenges when considering control of key quality attributes of in vitro and in vivo performance.

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  • 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) laboratories, our services can support you from early-phase formulation development, CMC support, clinical release testing, through to finished product release testing, and EU import testing. Our expertise includes integrated formulation development and scale-up, device screening, accelerated stability studies, clinical supply manufacture, and full CMC support. We routinely provide in-vitro bioequivalence studies (IV-BE) for generic products, including full GMP statistical analysis and dossier generation.
    Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety, and regulatory standards.

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  • 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 clinical trial materials, stability studies or on-going GMP batch release tests.

    Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.

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  • 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 Practice (GMP) compliant inhalation product analysis services are conducted by experts in programmable temperature and humidity-controlled laboratories according to guidance documents from regulatory authorities (CDER (FDA), EMEA). We support inhalation drug product development for a wide range of products such as pressurized metered dose inhalers (pMDI), dry powder inhalers (DPI), nebulizers or soft mist inhalers. These classes of OINDP have very different mechanisms of action and formulations and we ensure that the most suitable testing requirements are deployed.

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Intertek Pharmaceutical Services resources

  • 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
  • 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.
  • 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.
  • 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.
  • Brochure Brochure | Oligonucleotide Analytical Devlopment 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

    Our thought-leaders have over 25 years’ 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 North America and Europe, 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 manufact
  • Brochure Brochure | Bioanalysis Services

    Bioanalysis plays a critical role in the assessment of drug safety and efficacy. We understand that each project presents its own unique challenges, and by applying our 20 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 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.
  • Technical Data Factsheet | ATMP Analytical Development Services

    The complexity of Advanced Therapy Medicinal Products (ATMPs)  and their mode of action, present many challenges todevelopment. Our experts provide analytical development and routine testing to help you meet regulatory expectations for safety and efficacy. 
  • 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: https://www.intertek.com/pharmaceutical/glycosylation-analytical-approaches-whitepaper-intertek
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    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: https://www.intertek.com/pharmaceutical/stability-studies-drug-product-lifecycle/

  • 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 Article | Addressing Key Attrbutes 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: https://www.intertek.com/pharmaceutical/repurposing-vaccines-vaccines-intranasal-development/
  • Whitepaper WHITEPAPER | White Paper 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.
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    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 Video | Expert Interview on Biologics Characterisation

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  • 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 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.
  • Video WEBINAR | Current Analytical Approaches to Biophysical Characterization in a Regulatory Environment

    Structural integrity of protein-based therapeutics is one of the major challenges in the biopharmaceutical industry where multiple factors such as the stability, efficacy and shelf life could be affected following minor changes in manufacturing process. Multiple biophysical methods employing spectroscopic and calorimetric tools can be used for analysing Higher Order Structure (HOS). This presentation from Intertek’s biophysical expert, Anshuman Shukla, details different biophysical techniques, their application and usefulness in a regulatory setting.
  • Video WEBINAR | Development of a Quality Control Strategy for Vaccines

    Vaccines represent a diverse class of products within the pharmaceutical industry. All are complex and present their own unique challenges not only in production but in the design and implementation of strategic characterisation and quality control programs. The highest levels of safety and efficacy should be ensured through application of phase specific validated analytical methods.

    In this webinar, our expert, Ashleigh Wake, describes how to build strategic quality control programs, with a focus on mRNA and DNA-based vaccines, which are product and phase specific covering the need for specialist, bespoke analytical approaches for these highly complex products.
  • Video WEBINAR | A Comparison of qPCR and ddPCR Methods for Residual DNA Analysis

    In this webinar our expert discusses our HEK293 and E.Coli  Residual DNA quantification assays comparing a quantitative PCR (qPCR) approach with a more recent digital droplet PCR (ddPCR) technique in terms of sensitivity and reproducibility as well as discussing technical challenges.
  • Video WEBINAR | Monitoring of Glycosylation Using Site Specific Approaches for Antibody-based Therapeutics

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

    During this webcast, our expert Michael Walker discusses peptide mapping and middle-up mass spectrometry as characterization techniques that give relative levels of different glycoforms at specific sites, and compares to more common methodologies of enzymatic stripping and fluorescent labelling.
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    Intertek pharmaceutical contract laboratory services, regulatory guidance and supply chain assurance brings quality and safety to life to support your unique pharmaceutical or biopharmaceutical outsourcing requirements. Our scientists and regulatory experts work with you at every stage of development, providing consistently high quality and flexible GLP/GMP/GCP services that enable you to achieve a marketplace advantage. We enable our clients to navigate the challenges of new product development, scale up, manufacturing and market release through our specialist services including analysis, bioanalysis, formulation development, biologics characterization, inhalation development, regulatory consultancy, risk assessment, auditing and supply chain management solutions.
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