Extractables and Leachables Studies

News Boosting in Vitro Testing for Nasal Drug Products

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

Brochure Brochure - Pharmaceutical Services

Covering our full breadth of contract laboratory services, auditing and regulatory consultancy expertise, this brochures provides a summary of our global capabilities.
Visit www.intertek.com/pharmaceutical for more information.

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

Brochure Brochure - Inhalation Drug Product Development Expertise

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

News The Vaccine and Therapeutics Development Digital Resources Have Been Released

Our library of digital resources is available to enhance your knowledge-base and educate you along every step of the drug development process. Keep up-to-date with industry hot topics and the latest research developed by our thought-leaders.

Brochure Poster - Top 5 Considerations for Outsourcing Stability Storage

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.

News Expansion in characterisation and development support for mRNA vaccines and therapeutics.

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

Brochure Poster - Flexible Outsourcing Solutions, Laboratory Services

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

Brochure Brochure - Oligonucleotide Analytical Development Services

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

Brochure Brochure - Biopharmaceutical Analytical Development Support

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

Brochure Brochure - 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 unique challenges, and by applying our nearly 30 years of experience in conducting regulatory bioanalytical studies, our teams work closely with you to ensure that the best possible solutions are delivered, optimizing value for your programs. With Intertek as your partner, you have access to the scientific and regulatory knowledge of our bioanalytical experts, so that you can leverage the insight we bring to accelerate your drug development.

Brochure Brochure - mRNA Vaccine & Therapeutic Products Analytical Development Services

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

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

Whitepaper Whitepaper - Quality Control of Oligonucleotide Therapeutics

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

Whitepaper Whitepaper - Evaluating Properties of Liposomes

In this whitepaper our expert, describes analytical approaches to evaluate the physicochemical properties of liposomes for drug delivery systems according to the FDA Guidance for Liposome Drug Products.

Whitepaper Whitepaper - Monitoring of Glycosylation Analytical Approaches for Antibody-Based Therapeutics

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

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

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

Download whitepaper: www.intertek.com/pharmaceutical/glycosylation-analytical-approaches-whitepaper-intertek

Whitepaper Article - Addressing Key Attributes of Viral Vectors

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

Whitepaper Whitepaper - GMP Flow Cytometry

In this whitepaper our expert describes the applications, considerations and challenges of utilizing Flow Cytometry techniques in a regulatory environment.

Whitepaper Article - A Strategic Approach to Nitrosamine Screening in Drug Products

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

Whitepaper EBook - Flexible Contingency Outsourcing Solutions

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

Whitepaper Article - CMC Considerations for mRNA Based Therapeutics

This article discusses analytical approaches to characterise mRNA in early-stage development to support effective therapeutic programs.

Whitepaper Article - New Approaches to Bioassay Design

In this article our expert describes new approaches to study design that lead to reliable, more robust cell potency assays.

Whitepaper Article - Challenges in mAb Characterisation

In this article our experts describe the challenges which must be overcome when characterizing monoclonal antibodies in a GMP environment.

Whitepaper Article - Characterisation of Bispecifics

In this article our experts describe key considerations for the characterisation of bispecific antibodies.

Whitepaper Whitepaper - Repurposing Vaccines for Intranasal Development

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

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

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.

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.

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.

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

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.

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.

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/

Brochure Inhaled and Nasal Drug Development Services

We focus on critical parameters impacting drug delivery efficacy to intended targets across all respiratory product classes (Nasal, DPIs, pMDIs, nebulizers..)

Brochure LEARN MORE: Shared Audits

Our shared audits or joint audits for pharma or cosmetic supply chains provide a cost-effective solution for the audit of suppliers/subcontractors

Brochure LEARN MORE: Pharmaceutical Services

Over the last 30 years, our network of GLP, GCP or cGMP laboratories and consultants have provided high quality custom services

Brochure Overview: GMP and CMC Pharmaceutical Laboratory Services

Contract pharmaceutical laboratory services and outsourcing support to accelerate and optimise your drug development programs

Brochure LEARN MORE: ICH Stability Testing

30 years’ experience in stability studies integrated with comprehensive understanding of the latest developments in regional, country and ICH guidance.

Brochure LEARN MORE: Extractables and Leachables Testing

Our scientists conduct E&L analysis studies in accordance with regional guidance and nationally and internationally recognized standards

Brochure LEARN MORE: Biopharmaceutical Development Support Services

Our thought-leaders have over 25 years’ experience in biopharma development support proteins, mRNA, mAbs, vaccines, ADCs, peptides, oligos, biosimilars +

Brochure LEARN MORE: Inhalation Drug Development Services

Formulation development, reformulation, product characterization, method dev and validation, inhaler testing, device verification, IV BE, CMC support for NDAs +

Brochure OLIGONUCLEOTIDE THERAPEUTICS DEVELOPMENT SUPPORT SERVICE

Oligonucleotide analysis and drug development support services from the initial characterisation and CMC through to long term quality control.

Brochure Stability Storage and Stability Testing

With a network of ICH stability facilities in the UK, US and Australia, we offer extensive storage capacity and a range of conditions.

Brochure Bioanalysis Services

30 years of experience in conducting regulatory bioanalytical studies, optimizing value for your programs.

Brochure Audit Report Purchase

To meet growing demand for supplier information and greater detail about specific sites, our clients are increasingly requesting the purchase of audit reports

Brochure Shared Audits - Efficient auditing for your supply chain

Rapid implementation and optimisation of your audit schedule, providing a ‘win-win’ solution

Brochure USP <1663> & USP <1664> EXTRACTABLES & LEACHABLES

Assessment of extractables and leachables for pharmaceutical packaging and delivery systems, to assess interactions between drug formulations and materials

Brochure GENOTOXIC AND MUTAGENIC IMPURITIES ANALYSIS

Genotoxic impurities analysis to assess and control DNA reactive mutagenic impurities in pharmaceuticals

Brochure Extractable and Leachables

Extractables and leachables to quantify risks associated with leachable impurities from container closure systems for packaging human drugs, process equipment

Brochure Biopharmaceutical Services

Comprehensive biopharmaceutical bioanalysis, analysis, characterization, and potency services

Brochure INHALED & INTRANASAL BIOLOGIC DRUG DEVELOPMENT

Formulation strategies, testing, characterisation, stability, performance/release testing and clinical manufacturing capabilities for inhaled or nasal delivery

Brochure GLP/GCP Bioanalytical Services

Bioanalytical Expertise from Preclinical to Commercialisation

Brochure ICH Storage and Stability Testing

GMP Stability programs and ICH stability storage

Brochure Extractables and Leachables Expertise

Over 30 years of E&L study expertise across all CCS formats

Brochure INHALED & INTRANASAL BIOLOGIC DRUG DEVELOPMENT

Contract drug development expertise to accelerate your inhaled biomolecule to market

Brochure Inhaled and Nasal Drug Development Support Services

Formulation, Device selection, Stability, Analytical, CTM and more from our COE for OINDP development

Brochure CELL AND GENE THERAPIES ANALYTICAL DEVELOPMENT SERVICES

CMC Development Support, Characterisation, Stability and Quality Control Services

Brochure mRNA VACCINE AND THERAPEUTIC PRODUCTS ANALYTICAL DEVELOPMENT SERVICES

CMC Development Support, Characterisation, Stability, and Quality Control Services

Brochure OLIGONUCLEOTIDE THERAPEUTICS DEVELOPMENT SUPPORT SERVICES

CMC Development & Delivery Technologies Support, Characterisation, Stability and Quality Control Services

Brochure Biologics Drug Development Support Services

30 years of biologics drug development support services, characterization, E&L, stability and drug delivery support (OINDP and other formats)

Brochure Intertek Pharmaceutical Services

Contract pharmaceutical and biopharmaceutical GLP/GCP/GMP laboratory services, supply chain audits and regulatory guidance

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.

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