Gene Therapy Characterisation and Release Testing
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 (51)
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Product Pharmaceutical Services
Our pharmaceutical scientists and regulatory experts work with you at every stage of development, providing consistently high quality and flexible services that enable you to achieve a marketplace advantage. Over the last 30 years, our network of Good Laboratory Practice (GLP), Good Clinical Practice (GCP)... -
Product Intertek Pharmaceutical Services
To meet your unique pharma and biopharma outsourcing needs, Intertek delivers quality and safety through pharmaceutical contract laboratory services, regulatory support, and supply chain assurance. We bring quality and safety to life!
With our pharmaceutical experts working with you at ... -
Product Development and Validation of Analytical Methods
Analytical methods development & validation: We apply a broad range of analytical technologies - including chromatography, mass spectrometry, spectroscopy, biophysical and bioanalytical techniques - across diverse products and methods - to ensure every method is fit for its intended purpose.
... -
Product Bioanalytical Services (GLP/GCP)
Bioanalysis Services: We offer GLP/GCP-compliant method development, validation, method transfer, sample analysis, and pharmacokinetic/toxicokinetic support - all delivered from our state-of-the-art facilities and supported by automated data collection and reporting systems. For over 30 years, we have supp... -
Product Inhalation Drug Product Development Services
Inhalation Drug Development Services: With over 35 years of experience, our team supports the development of orally inhaled and nasal drug products (OINDPs), helping clients bring effective respiratory therapies to market. This includes formulation, stability, testing, product performance testing, in vitro... -
Product Biopharmaceutical Characterisation and Testing Services
Biopharmaceutical Characterization & Testing: By leveraging expert insight into a biologic’s structure, physicochemical properties, potency, and impurity profile, we help you achieve critical development milestones with confidence.
A range of expertise is available, includin... -
Product Extractables and Leachables Testing Services
Extractables & Leachables Testing: Our scientists conduct extractables and leachables testing in alignment with region-specific guidelines (EU, US, China), globally recognized standards (USP, ISO), GMP practices, PQRI recommendations, and regulatory requirements including USP chapters <665>, <... -
Product ICH Stability Testing, Storage & Program Management
Stability Storage Capabilities: We offer fully monitored and controlled storage solutions under all ICH conditions - or custom conditions as needed - including climate-controlled walk-in chambers, cabinets, refrigerated units, and freezers, with backup systems in place at every location. We have 24-hour al... -
Product Pharmaceutical Auditing Services
Pharmaceutical Auditing Services: Our audits are conducted in line with relevant regulatory standards, including GMP, GDP, GLP, GCP, and GVP. We also audit against IPEC guidelines for excipients, ISO 22716 (Cosmetics GMP), EFfCI GMP for cosmetic ingredients, ISO 15378 for packaging materials, ISO 13485 for... -
Product Formulation Development including Inhaled Products
Inhaled Product & Formulation Development: We support the development of inhaled drugs using experimental design approaches, integrated with stability testing and storage solutions tailored to your product needs. Our formulation specialists can provide a wide range of formulations in a timely and cost-... -
Product GMP and CMC Laboratory Services
GMP & CMC Laboratory Services: We deliver regulatory-driven, phase-appropriate laboratory support for CMC programs - from preformulation through formulation to product release - ensuring compliance and quality at every stage. Among our capabilities are centres of excellence for method development and ... -
Product mRNA Characterisation and Analysis
mRNA Characterization & Analysis: We support vaccine and therapeutic development through detailed characterization and analysis of mRNA, including assessments of clinical translation efficiency and immunogenicity. At our GLP / GCP / GMP laboratories, scientists can test a mRNA drug substance or drug pr...
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 - Orally Inhaled & Nasal Drug Product Development
35+ years of experience - supporting the development of OINDPs & clinical trial materials manufacturing. -
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 - Switzerland Analytical Laboratory
Pharmaceutical & Medical Device Testing Laboratory Services.
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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 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. -
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 - 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. -
Datasheet 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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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 - 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. -
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.
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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 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 - Monitoring of Glycosylation Using Site Specific Approaches for Antibody-based Therapeutics
Antibody-based Therapeutics N-linked glycosylation is a common post-translational modification on many antibody-based therapeutics, and has been linked to safety, stability and activity. Modification should therefore be monitored and controlled.
During this webcast, our expert Michael Walker discusses peptide mapping and middle-up mass spectrometry as characterization techniques that give relative levels of different glycoforms at specific sites, and compares to more common methodologies of enzymatic stripping and fluorescent labelling.
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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 & 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. -
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