Extractables and Leachables Testing Services
Product Description
Intertek Pharmaceutical Services
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GB -
2015On CPHI since
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4Certificates
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1000 - 4999Employees
Company types
Primary activities
Categories
Specifications
Intertek Pharmaceutical Services
-
GB
-
2015On CPHI since
-
4Certificates
-
1000 - 4999Employees
Company types
Primary activities
More Products from Intertek Pharmaceutical Services (29)
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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... -
Product Oligonucleotide Analytical Development Services
Analytical development services for oligonucleotides: For oligo-based drugs, our capabilities range from GLP bioanalysis to GLP/cGMP characterisation. We support product development, from quality control testing of amidite starting materials and early stage product characterization through to GMP batch rele... -
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... -
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 intend... -
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 ... -
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) laboratorie... -
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 clinica... -
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 P... -
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... -
Product Antibody / Monoclonal antibody therapeutics services
Monoclonal antibody therapeutics: We continually invest in advanced analytical instrumentation that allows us to deliver mAb analytical data with the highest degree of sensitivity, accuracy and resolution. Our experience spans recombinant monoclonal antibodies and related products such as biosimilars, fus... -
Product Gene Therapy Characterisation and Release Testing
Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity and ... -
Product Clinical Trial Supplies Manufacturing Services
Services for manufacturing clinical trial supplies: To meet your supply needs for investigational medicinal products (IMP) or investigational new drugs (IND) for clinical trials around the world, we provide GMP clinical trial materials manufacturing services. Integrated with raw material testing, sou...
Intertek Pharmaceutical Services resources (43)
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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.
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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.
www.intertek.com/pharmaceutical for more information -
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
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. -
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 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
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 Brochure - Global Stability Storage Facilities and Services
Global Stability Storage Facilities and 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 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. -
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: www.intertek.com/pharmaceutical/stability-studies-drug-product-lifecycle
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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.
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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.
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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
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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.
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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.
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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.
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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:
www.intertek.com/pharmaceutical/repurposing-vaccines-vaccines-intranasal-development -
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.
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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:
www.intertek.com/pharmaceutical/biopharmaceuticals/gene-therapy-characterisation -
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.
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