Intertek Pharmaceutical Services

Intertek Pharmaceutical Services
Product Description

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.

To learn more, visit our website: 

www.intertek.com/pharmaceutical

Read more Show less

Intertek Pharmaceutical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
Company types
Consultancy
Contract Service
Manufacturer/Innovator
View company profile
Categories
more categories Show less
Specifications
  • Supplied from
    Australia; France; India; Switzerland; United Kingdom; United States
More specifications Fewer specifications
Sales Markets
Show more Show less

Intertek Pharmaceutical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
Company types
Consultancy
Contract Service
Manufacturer/Innovator
View company profile

More Products from Intertek Pharmaceutical Services (92)

  • Method development and validation

    Product Method development and validation

    Intertek offers wide range of pharmaceutical services which includes method development. It belongs to bioanalytical services for preclinical and clinical studies category. Contact us for more information.
  • Oligonucleotide Therapeutic Services

    Product Oligonucleotide Therapeutic Services

    Oligonucleotide Therapeutic Services
  • Preformulation and Physical Characterisation

    Product Preformulation and Physical Characterisation

    Preformulation and Physical Characterisation
  • Protein Characterization and Analysis (ICH Q6B)

    Product Protein Characterization and Analysis (ICH Q6B)

    Services for protein analysis and characterization, including analysis of the protein structure, physicochemical properties, biological activity, immunochemical properties, and purity and impurities determination, in accordance with the ICH Q6B Guidelines for Protein Analysis and Characterization.
    ...
  • Protein Characterization and Analysis (ICH Q6B)

    Product Protein Characterization and Analysis (ICH Q6B)

    Services for protein analysis and characterization, including analysis of the protein structure, physicochemical properties, biological activity, immunochemical properties, and purity and impurities determination, in accordance with the ICH Q6B Guidelines for Protein Analysis and Characterization.
    q...
  • Regulatory Affairs

    Product Regulatory Affairs

    Regulatory Affairs
  • 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, h...
  • 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 su...
  • 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. ...
  • 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 stud...
  • 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 achie...
  • 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 th...
show all 92 other products

Intertek Pharmaceutical Services resources (55)

  • Intertek’s Pharmaceutical Audit Services Team celebrates 15 years of excellence

    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.

    21 Mar 2022
  • Brochure - Pharmaceutical Services

    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 - Inhalation Drug Product Development Expertise

    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.
  • Poster - Top 5 Considerations for Outsourcing Stability Storage

    Brochure Poster - Top 5 Considerations for Outsourcing Stability Storage

    WHAT SHOULD YOU EXPECT FROM YOUR OUTSOURCING PARTNER? WHAT DOES YOUR OUTSOURCING PARTNER NEED FROM YOU? 
    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.
  • Poster - Flexible Outsourcing Solutions, Laboratory Services

    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 - Oligonucleotide Analytical Development Services

    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 - Biopharmaceutical Analytical Development Support

    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 manufacturing programs forward.
  • Brochure - Global Stability Storage Facilities and Services

    Brochure Brochure - Global Stability Storage Facilities and Services

    Global Stability Storage Facilities and Services.
  • Brochure - Bioanalysis Services

    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 - mRNA Vaccine & Therapeutic Products Analytical Development Services

    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.
  • Poster - Flexible Outsourcing Solutions, Laboratory Services

    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.
  • Factsheet - ATMP Analytical Development Services

    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. 
  • Factsheet - Biomarker Services

    Technical Data Factsheet - Biomarker Services

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

    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: www.intertek.com/pharmaceutical/stability-studies-drug-product-lifecycle

  • Whitepaper - Quality Control of Oligonucleotide Therapeutics

    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 - Evaluating Properties of Liposomes

    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 - Monitoring of Glycosylation Analytical Approaches for Antibody-Based Therapeutics

    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: www.intertek.com/pharmaceutical/glycosylation-analytical-approaches-whitepaper-intertek
  • Article - Addressing Key Attributes of Viral Vectors

    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 - GMP Flow Cytometry

    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.
  • Article - A Strategic Approach to Nitrosamine Screening in Drug Products

    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.

  • EBook - Flexible Contingency Outsourcing Solutions

    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.

  • Article - CMC Considerations for mRNA Based Therapeutics

    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.
  • Article - New Approaches to Bioassay Design

    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.
  • Article - Challenges in mAb Characterisation

    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.
  • Article - Characterisation of Bispecifics

    Whitepaper Article - Characterisation of Bispecifics

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

    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: 
    www.intertek.com/pharmaceutical/repurposing-vaccines-vaccines-intranasal-development
  • WHITEPAPER - Download: Extractables and Leachables Strategies for Pharmaceutical Production Tubing

    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
  • Article - Overcoming Challenges to Inhaled Biologic Development

    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.

  • Article - Nebulised Drug Development Considerations

    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.
  • Article - In Vitro Bioequivalence for Pulmonary and Nasal Delivery

    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 - Glass Delamination Studies for Pharmaceutical Vials

    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 - Extractables and Leachables Strategies for Transdermal Delivery Patch Products

    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.
  • Strategic Partnerships with Contract Lab Services Organizations

    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.
  • Intranasal Delivery of Biologic Therapeutics

    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 - Cell and Gene Therapy Analytical Development Services

    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: 
    www.intertek.com/pharmaceutical/biopharmaceuticals/gene-therapy-characterisation
  • WEBINAR - Translating Inhaled and Nasal Technologies for the Delivery of Biologics

    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.
  • WEBINAR - Design of Robust Extractables and Leachables Studies

    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 - GMP Cryo-TEM Services

    Video VIDEO - GMP Cryo-TEM Services

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

    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 - Expert Interview on Biologics Characterisation

    Video VIDEO - Expert Interview on Biologics Characterisation

    Interview with Jordi Trafach, Intertek’s Associate Director, Biologics Characterization by BPI TV.
  • WEBINAR - Analytical Approaches for Identification and Quantification of Impurities In Pharmaceuticals

    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. 
  • WEBINAR - Repurposing Products for Inhaled Delivery - Rapid Response Strategies

    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 - Analysis and Characterization of mRNAs for Therapeutic and Vaccine Development

    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.
  • WEBINAR - Characterization and quantification of known & unknown substances by NMR

    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.
  • WEBINAR - Biocompatibility - The Importance of Extractables & Leachables Testing

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

    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.
  • WEBINAR - Development of a Quality Control Strategy for Vaccines

    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.
  • WEBINAR - A Comparison of qPCR and ddPCR Methods for Residual DNA Analysis

    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.
  • WEBINAR - Monitoring of Glycosylation Using Site Specific Approaches for Antibody-based Therapeutics

    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.
  • VIDEO - Intertek Pharmaceutical Services - Bringing Quality and Safety to Life

    Video VIDEO - Intertek Pharmaceutical Services - Bringing Quality and Safety to Life

    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.
  • WEBINAR - Top 4 Steps to a Perfect Outsourcing Partnership

    Video WEBINAR - Top 4 Steps to a Perfect Outsourcing Partnership

    This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme.
    In today's dynamic pharmaceutical landscape, companies look to focus on their core competencies and outsource for success. In this webinar, based on our 20+ years of experience providing flexible outsourcing strategies to the world's most innovative biopharmaceutical organisations, we share key learnings and discuss four key considerations for a perfect outsourcing partnership with a contract research organisation that helps to build mutual trust, optimise cost efficiencies, and mitigate risks:
    Communication What mode works for you? Focus on critical attributes Leverage partnership benefits
  • WEBINAR - Stability Studies and Outsourcing Solutions

    Video WEBINAR - Stability Studies and Outsourcing Solutions

    We share our thoughts on stability requirements for new drug substance or drug product, and steps required to ensure a robust stability program is implemented.
  • Take the Video Tour - Learn more about Intertek Pharmaceutical Services

    Video Take the Video Tour - Learn more about Intertek Pharmaceutical Services

    Watch our video tour now: https://youtu.be/XNRFUlrZcVQ

    Our scientists provide consistently high quality and flexible GLP/GMP/GCP services to enable you to navigate the challenges of new product development, scale up, manufacturing and market release.
  • GMP Stability Testing and Storage Capabilities

    Video GMP Stability Testing and Storage Capabilities

    With all ICH conditions storage and over 375,000L of capacity, including large scale walk-in units, bespoke storage cabinets and standard or ULT freezers, we provide end-to-end support for design, testing, storage and management for #pharma #stability studies. Learn More: https://www.intertek.com/pharmaceutical/analysis/stability/
  • VIDEO - Intertek Melbourn: Inhaled and Nasal Drug Product Development Expertise

    Video VIDEO - Intertek Melbourn: Inhaled and Nasal Drug Product Development Expertise

    Over the past 30 years, Intertek Melbourn, UK, has provided clients with testing and development services for orally inhaled and nasal drug products, including method development/validation, stability, CMC support, formulation development, repurposing, and clinical manufacturing.