Article - A Strategic Approach to Nitrosamine Screening in Drug Products

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. 

Bringing Quality, Sustainability & Safety to Life.

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.

Experts in rapid development strategies, analytical testing and formulation development services.

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 

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.

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.

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.

Intranasal nucleic acid therapy development support, from formulation and device testing to clinical manufacturing, CMC and regulatory expertise.

Flexible stability study outsourcing backed by 30+ years of expertise - minimising risk, maximising efficiency, and helping you to meet your milestones

Pharmaceutical & Medical Device Testing Laboratory Services.

Finding the right formulation platform and then pairing this with an appropriate device is critical to the success of an inhalation project.

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.

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.

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.

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.

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

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. 

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

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.

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.

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.

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.

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.

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

This video describes Intertek's GMP Cryo-TEM Services supporting the development of safe and effective advanced therapies.

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. 

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.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

Bioanalytical Expertise from Preclinical to Commercialisation

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

Contract drug development expertise to accelerate your inhaled biomolecule to market

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.

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

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

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.

Flexible GLP / GCP / GMP contract lab services, supply chain audits and regulatory guidance supporting drug development and production.

Formulation Development, Clinical Manufacturing and Analytical Support, R&D Analytical Support

ICH stability storage services for pharmaceutical or healthcare products where large capacity storage and ICH or bespoke conditions are required

CMC support for registration (NDAs/ANDAs), formulation development, GMP analytical testing, product characterisation, stability testing & clinical manufacturing

Formulation and device testing to in-vitro bioequivalence (IVBE) studies and GMP-compliance clinical trial manufacturing for both sprays and powders.

GMP clinical trial manufacturing to meet supply needs for investigational medicinal product (IMP) or investigational new drugs (IND) for clinical trial supplies

GC-MS, GC-MS/MS, LC-MS/MS and LC-HRMS nitrosamine ID, screening and quantification methods, including method validations to support regulatory submissions

GMP elemental impurity analysis services according to USP General Chapter and USP Chapter

Individual Audits, Shared Audits, Internal Audits, Audit Report Purchases

20 years of experience, we support GCP audits worldwide. Our Services include: Investigator site audits, CRO audit, Phase I unit audits, and supplier/vendor

Orthogonal protein analysis approaches that address key molecular & biological characteristics to ensure the safety and efficacy of your specific biologic

GLP/GCP/GMP analytical development and CMC support services to accelerate advanced therapy development, quality control and regulatory compliance.

Peptide characterisation services supporting drug development through analytical testing, formulation studies, quality assessment and regulatory compliance.

Formulation development integrated with analytical development services to optimize inhaled / nasal drug products or powder, capsule, liquid or solid dose

Laboratory services according to United States Pharmacopeia (USP) Chapter , ‘Evaluation of the Inner Surface Durability of Glass Containers’ to monitor ‘

Immunogenicity assays to detect anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) to support global nonclinical and clinical studies

Cell-based neutralizing antibody assay services supporting biologics development, potency testing, immunogenicity assessment and regulatory compliance.

White paper on pharmaceutical particle determination, covering contamination analysis, testing methods and product quality assurance.

Insights to support the development of robust, stable ADC products and to help navigate the analytical challenges associated with these advanced therapeutics.

Analytical, bioanalytical and potency testing for proteins, antibodies, vaccines, ADCs, peptides, cytokines, oligonucleotides and biosimilars.

ntertek can support you at every stage, with its 40 years of expertise in controlled environments: The different stages of our smoke test intervention:

Bioanalysis, GMP and CMC Lab Services, Biopharma Characterisation, Drug Delivery and Formulation Expertise, Auditing

Over 35 years of experience in supporting the development of OINDPs, and clinical trial materials manufacturing

For over 30 years, Intertek has specialised in providing analytical, formulation and clinical manufacturing services for the development of inhaled and nasal

partnership with CrystecPharma, focusing on advancing formulation science and accelerating development timelines for inhaled medicines, particularly dry powder

Over 20 years of experience in stability studies

Pharmaceutical & Medical Device Testing Laboratory Services

This white paper delves into the risks due to leachables associated with bioprocessing SUS and explores risk-based strategies for their mitigation.

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

As your healthcare supply chain auditing partner, we can help you to ensure that products, processes, facilities and quality systems meet quality standards

Extractables & leachables to quantify risks associated with container closure systems for packaging human drugs, process equipment or medical devices

Extractables and leachables studies of plastic bioprocessing single-use systems (SUS) that help you to assess and control risks due to leachables from SUS

ISO 10993-18 chemical characterisation of medical device materials, biocompatibility testing for medical devices including extractables leachables supporting id

USP 1663 and USP 1664 assessment of extractables leachables for pharmaceutical packaging and delivery systems to assess interactions between drug formulations a

ICH stability testing for pharma drug substances or drug products with efficient study management, standard or bespoke storage conditions to meet your needs

Analytical method development and validation laboratory services supporting drug development enabling regulatory-driven and phase-appropriate methods

Formulation development integrated with analytical development services to optimize your inhaled and nasal drug products and powder, capsules liquid or solid

Nasal drug product development for nasal spray drug or nasal powder spray pharmaceuticals or vaccines. Optimising intranasal drug performance and quality throug

Nebulised drug development: CMC Support, formulation development, product performance testing, in vitro bioequivalence studies, stability, characterisation

GMP clinical trial material manufacturing services to meet your supply needs for investigational medicinal product (IMP) or investigational new drugs (IND) for

ICH Q3D elemental impurity testing services and toxicological risk assessment to support the implementation or maintenance of your elemental impurity programs

United States Pharmacopeia (USP) and elemental impurities testing in drug products including screening and quantification of potentially toxic metal

Liposome drug characterisation according to FDA manufacturing and controls (CMC): physicochemical properties, cryo-TEM, compositition, encapsulation efficiency

Drug delivery laboratory services and expertise in targeted drug delivery development. We have 30 years of experience in the development of complex dosage forms

Chemistry, manufacturing and controls (CMC) and GMP contract pharmaceutical laboratory services and outsourcing support to accelerate and optimise your drug dev

Pharmaceutical particle and powder characterization services to assist understanding of physical properties to optimize formulation and production

Pharmaceutical impurities testing to meet ICH Q3A / Q3B / Q3C /Q3D, M7 and more

Genotoxic impurities analysis to assess and control DNA reactive mutagenic impurities. Our GMP labs support the identification, quantification.

Pharmaceutical dissolution testing for solid dosage forms including routine dissolution and advanced methods for immediate or controlled release systems

Analytical support for polymers in drug delivery and novel polymer pharmaceutical ingredients with expert analysis, stability, and quality testing,

Residual solvent (RS) and organic volatile impurities (OVI or VOCs) identification and quantification in pharmaceutical drug substances, excipients and drug pro

Glass delamination studies (USP ) for pharmaceutical vials, syringes or drug bottle packaging including inner surface durability testing, screening

Analysis of pharmaceutical nanoparticles can deliver a wealth of information to assist product development particularly for complex drug delivery technologies,

Nitrosamine impurities like N-nitrosodimethylamine (NDMA) have raised significant concerns within the pharmaceutical industry, as highlighted by the US FDA