Elemental Impurity Testing ICH Q3D
Product Description
Intertek Pharmaceutical Services
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Country/Region:United Kingdom
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On CPHI since:2015
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Certificates:4
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Employees:1000 - 4999
Company types
Primary activities
Categories
Specifications
Intertek Pharmaceutical Services
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Country/Region:United Kingdom
-
On CPHI since:2015
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Certificates:4
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Employees:1000 - 4999
Company types
Primary activities
More Products from Intertek Pharmaceutical Services (50)
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Product Pharmaceutical Impurity Testing
Our GMP compliant laboratories provide pharmaceutical impurity testing for new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)) which can support your product development from an early stage and across the lifecycle of your drug product including method development / validation and di... -
Product GMP Auditing
Intertek provides GMP audit services to support pharmaceutical, biopharmaceutical and healthcare companies in assessing, qualifying and monitoring suppliers, manufacturers and service providers across global supply chains.
Our audits evaluate compliance with applicable Good Manufacturing P... -
Product Protein Aggregation Analysis and Characterization
Analysis and characterization of protein aggregates: The services provided by our experts include a range of protein aggregation analysis techniques that are used to detect and quantify aggregates in solution in support of formulation development, quality control, stability studies, comparability, rel... -
Product Genotoxic Impurities ID and Quantification
Identification and quantification of genotoxic impurities: To reduce drug safety and quality risks, diagnosing and limiting genotoxic impurities early on in drug development can reduce risk associated with genotoxic impurities. With the implementation of increasingly stringent regulations for impurity l... -
Product Protein Therapeutic Glycosylation Studies
In line with ICH Q6B, we deliver glycosylation analysis for proteins, antibodies, bispecifics including assessment of the glycosylation site, carbohydrate content and glycan structure. With a range of MS approaches, our protein characterisation scientists provide detailed glycosylation studies designed to ... -
Product ATMP Analytical Development Services
Advanced therapy medicinal product (ATMP) analytical services & chemistry, manufacturing, and control (CMC) support including characterisation, stability and release testing. Our GLP / GCP / GMP laboratories have supported developers and manufacturers for over 20 years through the provision of adv... -
Product Biocompatibility - E and L Studies for Medical Device or Combination Products
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 IS... -
Product Immunogenicity Assays
Intertek offers immunogenicity assays for detection of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) in support of nonclinical and clinical studies. Our immunogenicity assay experts utilize a multi-tiered approach to measure ADAs and NAbs, and are experienced in the development and va... -
Product Ligand-binding Assays
Intertek offers wide range of pharmaceutical services which includes ligand-binding assays. It belongs to immunochemistry services category. It includes elisa, electrochemiluminescence (ecl), radioimmunoassay (ria), etc.
To learn more, visit our website:
www.intertek.com/pharmaceut... -
Product Pharma Materials Physical Characterisation
Our solid state characterisation teams support pharmaceutical product development during through API solid state characterisation packages to determine particle shape and size distribution, surface area, porosity, moisture or solvent content, solubility, pH, solid state stability, solution stability and th... -
Product Quality Control Testing Services
QC testing of pharmaceutical raw materials to international pharmacopoeia specifications has become a specialty of Intertek. With our knowledge of analytical chemistry and our vast range of instrumental techniques, we can undertake the vast majority of the chemical tests listed within the international pha... -
Product Glass delamination and Interaction studies
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...
Intertek Pharmaceutical Services resources (106)
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News Intertek expands one of Europe's largest GMP pharma stability storage facilities
Cambridge, UK: Intertek, a Total Quality Assurance provider for industries worldwide, has announced the expansion of its UK GMP (Good Manufacturing Practice) pharmaceutical stability storage facility in Royston near Cambridge, UK. With a total capacity of 625,000 litres, the expansion consolidates its position as one of the largest contract storage facilities in Europe.
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Video Video - Intertek Pharmaceutical Services
Bringing Quality, Sustainability & Safety to Life. -
News Intertek Expands to Enhance Capabilities in Inhaled Biologics Drug Development
Intertek, a leading Total Quality Assurance provider to industries worldwide, is expanding its Good Manufacturing Practice (GMP) pharmaceutical services laboratory in Melbourn, near Cambridge, UK.
By adding 6,000 square feet of purpose-built laboratory and office space, increasing the total footprint to 46,000 square feet, the expanded laboratory will enhance Intertek’s capabilities for inhaled biologics, addressing rising global client demand.
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Video Video - 35+ years’ experience across all respiratory delivery technology platforms
Experts in rapid development strategies, analytical testing and formulation development services. -
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. -
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 - Orally Inhaled & Nasal Drug Product Development
35+ years of experience - supporting the development of OINDPs & clinical trial materials manufacturing.
Intertek's Orally Inhaled and Nasal Drug Product Development Services provide end-to-end support for the development of inhaled and nasal therapies, from formulation design and analytical testing to clinical manufacturing and regulatory submission. Leveraging over 35 years of respiratory expertise, GMP-approved facilities, and specialized capabilities in biologics, low-GWP inhalers, and advanced particle engineering, Intertek helps pharmaceutical companies accelerate development, ensure product performance, and bring innovative respiratory medicines to market with confidence. -
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 Nasal Drug Product Development for Oligonucleotide or mRNA Therapeutics
Intranasal nucleic acid therapy development support, from formulation and device testing to clinical manufacturing, CMC and regulatory expertise. -
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 ICH Stability Storage & cGMP Stability Studies
Flexible stability study outsourcing backed by 30+ years of expertise - minimising risk, maximising efficiency, and helping you to meet your milestones -
Brochure Brochure - Switzerland Analytical Laboratory
Pharmaceutical & Medical Device Testing Laboratory Services.
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Brochure Independent Inhaled/Nasal Device Selection Support (Large & Small Molecules)
Finding the right formulation platform and then pairing this with an appropriate device is critical to the success of an inhalation project. -
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 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 - mRNA Vaccine & Therapeutic Products Analytical Development Services
By integrating advanced analytical technology with a heritage supporting pharmaceutical product development, our experts offer Total Quality Assurance to help you ensure the safety, efficacy, and quality of your mRNA therapy. -
Brochure 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. -
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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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. -
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 - 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 - 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 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 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 - 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 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 - 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 -
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: 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 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 GLP/GCP Bioanalytical Services
Bioanalytical Expertise from Preclinical to Commercialisation -
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 Cell and Gene Therapies Analytical Development Services
CMC Development Support, Characterisation, Stability and Quality Control Services
Intertek's Cell and Gene Therapies Analytical Development Services brochure outlines comprehensive CMC, analytical development, characterisation, stability and quality control solutions for advanced therapy developers. Supporting viral vectors, mRNA, plasmid DNA and engineered cell therapies, Intertek's GLP-, GCP- and GMP-compliant laboratories provide expert analytical testing, method development, potency assessment, bioanalysis, stability studies and batch release testing to help accelerate development, ensure product quality and meet evolving regulatory requirements. -
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) -
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. -
Brochure Pharmaceutical Testing, Auditing and Regulatory Services
Flexible GLP / GCP / GMP contract lab services, supply chain audits and regulatory guidance supporting drug development and production. -
Brochure Pharmaceutical Analysis Services
Formulation Development, Clinical Manufacturing and Analytical Support, R&D Analytical Support -
Brochure ICH Stability Storage Services
ICH stability storage services for pharmaceutical or healthcare products where large capacity storage and ICH or bespoke conditions are required -
Brochure Inhalation Drug Development Services
CMC support for registration (NDAs/ANDAs), formulation development, GMP analytical testing, product characterisation, stability testing & clinical manufacturing -
Brochure End-to-end Nasal Drug Product Development Support
Formulation and device testing to in-vitro bioequivalence (IVBE) studies and GMP-compliance clinical trial manufacturing for both sprays and powders. -
Brochure Clinical Trial Material Manufacturing Services
GMP clinical trial manufacturing to meet supply needs for investigational medicinal product (IMP) or investigational new drugs (IND) for clinical trial supplies -
Brochure Nitrosamines Testing
GC-MS, GC-MS/MS, LC-MS/MS and LC-HRMS nitrosamine ID, screening and quantification methods, including method validations to support regulatory submissions -
Brochure USP 232 and 233 Pharmaceutical Elemental Impurity Testing
GMP elemental impurity analysis services according to USP General Chapter and USP Chapter -
Brochure Supply Chain Auditing
Individual Audits, Shared Audits, Internal Audits, Audit Report Purchases -
Brochure GCP Auditing
20 years of experience, we support GCP audits worldwide. Our Services include: Investigator site audits, CRO audit, Phase I unit audits, and supplier/vendor -
Brochure Biopharmaceutical Development Support Services
Orthogonal protein analysis approaches that address key molecular & biological characteristics to ensure the safety and efficacy of your specific biologic -
Brochure Cell & Gene Therapy Charactersation
GLP/GCP/GMP analytical development and CMC support services to accelerate advanced therapy development, quality control and regulatory compliance. -
Brochure Peptide Characterisation
Peptide characterisation services supporting drug development through analytical testing, formulation studies, quality assessment and regulatory compliance. -
Brochure Formulation Development Contract Services
Formulation development integrated with analytical development services to optimize inhaled / nasal drug products or powder, capsule, liquid or solid dose -
Brochure Glass Delamination Testing for Pharmaceutical Containers
Laboratory services according to United States Pharmacopeia (USP) Chapter , ‘Evaluation of the Inner Surface Durability of Glass Containers’ to monitor ‘ -
Brochure Immunogenicity Assays Services
Immunogenicity assays to detect anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) to support global nonclinical and clinical studies -
Brochure Cell-Based Neutralizing Antibody Assays Services
Cell-based neutralizing antibody assay services supporting biologics development, potency testing, immunogenicity assessment and regulatory compliance. -
Brochure White Paper: Analytical Strategies to Identify Particulate in Pharma Products
White paper on pharmaceutical particle determination, covering contamination analysis, testing methods and product quality assurance. -
Brochure Antibody-Drug Conjugates Stability White Paper
Insights to support the development of robust, stable ADC products and to help navigate the analytical challenges associated with these advanced therapeutics. -
Brochure biopharmaceutical bioanalysis, analysis, characterization, and potency
Analytical, bioanalytical and potency testing for proteins, antibodies, vaccines, ADCs, peptides, cytokines, oligonucleotides and biosimilars. -
Brochure Smoke test - visualization and control of air flows
ntertek can support you at every stage, with its 40 years of expertise in controlled environments: The different stages of our smoke test intervention: -
Brochure Intertek Pharmaceutical Lab Services & Auditing
Bioanalysis, GMP and CMC Lab Services, Biopharma Characterisation, Drug Delivery and Formulation Expertise, Auditing -
Brochure Orally Inhaled and Nasal Drug Product Development
Over 35 years of experience in supporting the development of OINDPs, and clinical trial materials manufacturing -
Brochure Press Release: Intertek Enhances Capabilities in Inhaled Biologics Development
For over 30 years, Intertek has specialised in providing analytical, formulation and clinical manufacturing services for the development of inhaled and nasal -
Brochure Intertek partners with CrystecPharma to advance formulation science
partnership with CrystecPharma, focusing on advancing formulation science and accelerating development timelines for inhaled medicines, particularly dry powder -
Brochure ICH STABILITY STORAGE & cGMP STABILITY STUDIES
Over 20 years of experience in stability studies -
Brochure SWITZERLAND ANALYTICAL LABORATORY
Pharmaceutical & Medical Device Testing Laboratory Services -
Brochure White Paper: Risk-Based E&L Strategies For Bioprocessing Single-Use Systems
This white paper delves into the risks due to leachables associated with bioprocessing SUS and explores risk-based strategies for their mitigation. -
Brochure Oligonucleotide Development Services
CMC Development & Delivery Technologies Support, Characterisation, Stability and Quality Control Services -
Brochure Healthcare, Pharmaceutical and Cosmetics Supply Chain Auditing
As your healthcare supply chain auditing partner, we can help you to ensure that products, processes, facilities and quality systems meet quality standards -
Brochure Extractables and Leachables Testing
Extractables & leachables to quantify risks associated with container closure systems for packaging human drugs, process equipment or medical devices -
Brochure USP <665>, USP<1665> Extractables & Leachables for Bioprocessing SUS
Extractables and leachables studies of plastic bioprocessing single-use systems (SUS) that help you to assess and control risks due to leachables from SUS -
Brochure ISO 10993-18 Medical Device Chemical Characterization /Extractables Leachables
ISO 10993-18 chemical characterisation of medical device materials, biocompatibility testing for medical devices including extractables leachables supporting id -
Brochure USP 1663 USP 1664 Extractables Leachables
USP 1663 and USP 1664 assessment of extractables leachables for pharmaceutical packaging and delivery systems to assess interactions between drug formulations a -
Brochure ICH Stability Testing
ICH stability testing for pharma drug substances or drug products with efficient study management, standard or bespoke storage conditions to meet your needs -
Brochure Analytical Method Development and Validation Supporting Drug Development
Analytical method development and validation laboratory services supporting drug development enabling regulatory-driven and phase-appropriate methods -
Brochure Pharmaceutical Formulation Development Contract Services
Formulation development integrated with analytical development services to optimize your inhaled and nasal drug products and powder, capsules liquid or solid -
Brochure Nasal Drug Product Development
Nasal drug product development for nasal spray drug or nasal powder spray pharmaceuticals or vaccines. Optimising intranasal drug performance and quality throug -
Brochure Nebulised Drug Product Development Services
Nebulised drug development: CMC Support, formulation development, product performance testing, in vitro bioequivalence studies, stability, characterisation -
Brochure Clinical Trial Materials Manufacturing Services
GMP clinical trial material manufacturing services to meet your supply needs for investigational medicinal product (IMP) or investigational new drugs (IND) for -
Brochure ICH Q3D Guideline For Elemental Impurities Testing & Risk Assessment
ICH Q3D elemental impurity testing services and toxicological risk assessment to support the implementation or maintenance of your elemental impurity programs -
Brochure USP 232 and 233 Pharmaceutical Elemental Impurity
United States Pharmacopeia (USP) and elemental impurities testing in drug products including screening and quantification of potentially toxic metal -
Brochure Liposome Characterisation
Liposome drug characterisation according to FDA manufacturing and controls (CMC): physicochemical properties, cryo-TEM, compositition, encapsulation efficiency -
Brochure Drug Delivery Development Services
Drug delivery laboratory services and expertise in targeted drug delivery development. We have 30 years of experience in the development of complex dosage forms -
Brochure GMP and CMC Pharmaceutical Laboratory Services
Chemistry, manufacturing and controls (CMC) and GMP contract pharmaceutical laboratory services and outsourcing support to accelerate and optimise your drug dev -
Brochure Powder and Particle Characterisation
Pharmaceutical particle and powder characterization services to assist understanding of physical properties to optimize formulation and production -
Brochure Pharmaceutical Impurity Testing
Pharmaceutical impurities testing to meet ICH Q3A / Q3B / Q3C /Q3D, M7 and more -
Brochure Genotoxic Impurities and Mutagenic Impurities Analysis
Genotoxic impurities analysis to assess and control DNA reactive mutagenic impurities. Our GMP labs support the identification, quantification. -
Brochure Pharmaceutical Dissolution Testing
Pharmaceutical dissolution testing for solid dosage forms including routine dissolution and advanced methods for immediate or controlled release systems -
Brochure Polymers in Drug Delivery
Analytical support for polymers in drug delivery and novel polymer pharmaceutical ingredients with expert analysis, stability, and quality testing, -
Brochure Residual Solvents and Organic Volatile Impurities (OVI) Analysis
Residual solvent (RS) and organic volatile impurities (OVI or VOCs) identification and quantification in pharmaceutical drug substances, excipients and drug pro -
Brochure Glass Delamination Testing
Glass delamination studies (USP ) for pharmaceutical vials, syringes or drug bottle packaging including inner surface durability testing, screening -
Brochure Nanoparticle Analysis
Analysis of pharmaceutical nanoparticles can deliver a wealth of information to assist product development particularly for complex drug delivery technologies, -
Brochure Nitrosamine Impurity Testing
Nitrosamine impurities like N-nitrosodimethylamine (NDMA) have raised significant concerns within the pharmaceutical industry, as highlighted by the US FDA