News from LabRulezLCMS Library - Week 12, 2026

The leaflet outlines the role and handling of analytical equipment and systems in the process of a laboratory dealing with the analysis of chemical elements and molecules. It is an introduction to topics being considered by the Eurachem Analytical Equipment and Systems Qualification Working Group.&nbsp;Various steps are required to draw a conclusion concerning the object being examined (sampling target), see Fig. 1. The core part, the analytical measurement, is based on an analytical principle. The measurement is based on a physical or chemical interaction, e.g. between light of a certain wavelength and the sample, which leads to a displayed measured value. This measurement is carried out using analytical equipment. This equipment must be fit for its intended use. Complex analytical equipment with extensive data processing is referred to as a system. Analytical equipment is used to perform the analytical method. The method must be validated to demonstrate that it is fit for purpose.&nbsp;<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Eurachem_Fig_1_Analytical_principle_method_and_procedure_1_b751d25236.jpg" alt="Eurachem: Fig. 1 Analytical principle, method and procedure [1]" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Eurachem_Fig_1_Analytical_principle_method_and_procedure_1_b751d25236.jpg 245w," sizes="100vw" width="841" height="439"><h4>The pyramid of quality&nbsp;</h4>The pyramid of quality (Fig. 2) covers the analytical method. In order to produce a reproducible, reportable result that is suitable for the intended purpose, the equipment (system) (1st level) and analytical method (2nd level) must be well defined and under control, qualified or validated, respectively.&nbsp;<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Eurachem_Fig_2_Pyramid_of_quality_979312ac6b.jpg" alt="Eurachem: Fig. 2 Pyramid of quality" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Eurachem_Fig_2_Pyramid_of_quality_979312ac6b.jpg 163w," sizes="100vw" width="708" height="677">The equipment must have similar performance when carrying out the analyses as when developing and validating the method. Particularly in the case of methods based on libraries or training datasets, the long-term stability of the equipment must be ensured. In the case of transfer of the method to other equipment, both sets of equipment must have similar performance.&nbsp;The performance of the equipment and the behaviour of the method are monitored by quality control measures. This is the purpose of the internal or short term (3rd level) and inter-laboratory or long term (4th level) quality assurance. When selecting the quality assurance elements, the findings from levels 1 and 2 are taken into account.&nbsp;<h4>Is "calibration" sufficient?&nbsp;</h4>All relevant quality assurance systems, e.g. those meeting the requirements of ISO/IEC 17025 [2] and related standards, require equipment and systems to be traceably calibrated. But is that enough to prove the fitness for the intended use of the analytical equipment?&nbsp;According to the definition in VIM [3] calibration is the operation that, under specified conditions, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties. It is implicitly assumed that the influencing quantities (e.g. ambient conditions, temperature, flow rates, intensities of signal sources, etc.) are constant and do not exhibit any short or long-term fluctuations or drifts. This assumes that no changes occur due to influencing quantities.&nbsp;Nevertheless this is not the case in everyday analytical work. The influence of fluctuations or changes in the influencing quantities is evaluated through robustness investigations during method development and validation. The magnitude of the fluctuations or deviations of the equipment is specified and verified during equipment qualification.&nbsp;<h4>The Fitness for Intended Use&nbsp;</h4>The life cycle (Fig. 3) of new equipment to be purchased by the laboratory begins with the definition of the requirements and the intended use of the equipment.&nbsp;<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Eurachem_Fig_3_Equipment_or_system_lifecycle_2919ea802d.jpg" alt="Eurachem: Fig. 3 Equipment or system lifecycle" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Eurachem_Fig_3_Equipment_or_system_lifecycle_2919ea802d.jpg 186w," sizes="100vw" width="887" height="742">The User Requirement Specifications (URS) define the selection criteria and the operational ranges of the equipment parameters (influence variables), e.g. flows, temperatures, analysis volumes, etc. Considerations to support data integrity and traceability are also included in the URS. For more complex systems, the interfaces and compatibility of the components are essential.&nbsp;All considerations made in this phase have an impact on the entire life cycle, i.e. right through to decommissioning. The stability and variability of the influence variables are monitored over the entire service life.&nbsp;In most cases, data and metadata should remain accessible and analysable beyond the end of the equipment's life. The laboratory must use its resources as sparingly and sustainably as possible. This includes the expected service life and the costs incurred. Data integrity considerations (ALCOA+ = Attributable, Legible, Contemporaneous, Original, Accurate, + Complete, Consistent, Enduring, Available) play a role during operation and at the end of life. These include paper records and electronic records.&nbsp;In the pharmaceutical industry, qualification of equipment and thus ensuring that analytical equipment and systems are suitable for the intended use, is mandatory, and the respective processes are often clearly defined. Specifications are also comprehensively defined for various equipment classes.&nbsp;The ISO standards, in particular ISO 9001 [4], ISO 10012 [5], ISO/IEC 17025 [2], ISO 17034 [6] or ISO/IEC 17043 [7], cover a very large area and a wide range of sectors. For specific sectors, an interpretation of the standards is required. Eurachem guides cover requirements for analytical chemistry and related disciplines. The Analytical Equipment and Systems Qualification Working Group is therefore developing guidance on establishing the fitness for intended use of analytical equipment and systems aimed at these disciplines.

Fitness for the intended use of analytical equipment and systems

🎤Andreas MetousisIn this episode of Concentrating on Chromatography, we sit down with Andreas Metousis, a PhD researcher at the Max Planck Institute of Biochemistry, to explore cutting-edge spatial proteomics and its role in understanding ovarian cancer development.Andreas discusses how Deep Visual Proteomics (DVP)—a method combining artificial intelligence, laser micro-dissection, and advanced mass spectrometry—is revolutionizing cancer research by providing unprecedented insight into the earliest molecular events in disease progression.<h4>Key Topics Covered:</h4><ul><li>How transcriptomics and proteomics differ and why both matter for cancer research</li><li>Deep Visual Proteomics (DVP): AI-driven cell identification and high-resolution protein analysis</li><li>Why high-throughput automation (384-well plates, EVOSEP, Thermo Fisher Orbital Astral Mass Spectrometer) is essential for modern proteomics</li><li>The IDO1 paradox: why an "immune evasion" protein actually protects cancer cells—and why that matters for failed clinical trials</li><li>Translating lab discoveries into real-world therapeutics: the drug development pipeline</li><li>Applying spatial proteomics beyond ovarian cancer (lung cancer, skin cancer, osteoarthritis, muscle biology)</li><li>Advice for students entering cancer research and academia</li></ul><h4>Why This Matters:</h4>Andreas's work demonstrates how multi-modal omics integration and spatial resolution can identify novel drug targets and explain why some promising therapies fail in clinical practice. This episode bridges fundamental science with practical lab methodology and therapeutic impact.Perfect for: Analytical chemistry professionals, cancer researchers, graduate students, and anyone interested in how cutting-edge mass spectrometry and AI are transforming biomedical research.<h3>Video Transcription</h3>In this interview, Andreas discusses his research focused on uncovering early molecular events in ovarian cancer. By studying tissue samples ranging from early precursor lesions to advanced metastatic disease, his team applies spatial proteomics and transcriptomics to track how proteins and gene expression change along the disease progression. These approaches help identify potential diagnostic biomarkers and therapeutic targets that could ultimately improve patient outcomes.A key methodological innovation highlighted is deep visual proteomics (DVP), which integrates artificial intelligence with mass spectrometry-based workflows. Using deep learning, researchers can identify and classify specific cell populations within tissue sections, isolate them via laser microdissection, and analyze their protein composition in high detail. This targeted approach overcomes limitations of traditional bulk tissue analysis, where signals from different cell types can mask biologically relevant changes.The interview also explores the importance of high-throughput laboratory infrastructure. Automated liquid handling systems, robust LC workflows, and high-resolution mass spectrometry platforms enable the processing of hundreds of low-volume samples daily while maintaining sensitivity and reproducibility. Such technological integration allows researchers to study complex biological processes at unprecedented depth and scale.A major scientific insight from the work concerns the enzyme IDO1. Although previously considered a target for cancer inhibition, Andreas’ findings suggest that suppressing IDO1 may paradoxically protect cancer cells from death, helping explain failures in clinical trials of IDO1 inhibitors. While promising new therapeutic targets have been identified, he emphasizes that translating discoveries into clinical treatments requires extensive validation and long-term development. The interview concludes with reflections on resilience in scientific research and the broader applicability of spatial proteomics methods across multiple diseases.<blockquote>This text has been automatically transcribed from a video presentation using AI technology. It may contain inaccuracies and is not guaranteed to be 100% correct.</blockquote><blockquote><h4>Concentrating on Chromatography Podcast</h4>Dive into the frontiers of chromatography, mass spectrometry, and sample preparation with host David Oliva. Each episode features candid conversations with leading researchers, industry innovators, and passionate scientists who are shaping the future of analytical chemistry. From decoding PFAS detection challenges to exploring the latest in AI-assisted liquid chromatography, this show uncovers practical workflows, sustainability breakthroughs, and the real-world impact of separation science. Whether you’re a chromatographer, lab professional, or researcher you'll discover inspiring content!You can find Concentrating on Chromatography Podcast in podcast apps:<ul><li><a target="_blank" rel="noopener noreferrer" href="https://open.spotify.com/show/1wZg67rCjoGju4yhqxI3tL">Spotify</a></li><li><a target="_blank" rel="noopener noreferrer" href="https://podcasts.apple.com/tz/podcast/concentrating-on-chromatography/id1788429185">Apple podcast</a></li><li><a target="_blank" rel="noopener noreferrer" href="https://podscan.fm/podcasts/concentrating-on-chromatography">podscan</a></li></ul>and on <a target="_blank" rel="noopener noreferrer" href="https://www.youtube.com/@ChromatographyTalk/videos">YouTube channel</a></blockquote>

Mapping Cancer's Blueprint: How Spatial Proteomics is Revolutionizing Detection

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Eurachem is a European network promoting international traceability of chemical measurements and good analytical practice. It provides expert guidance, supports method validation, uncertainty evaluation, proficiency testing, and facilitates discussion on technical and policy issues in analytical quality.

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Organomation, founded in 1959, designs and manufactures high-quality nitrogen evaporators and extraction systems. Known for innovation and durability, their lab instruments are used globally for efficient sample preparation with strong customer support.

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<div>Lipid nanoparticles (LNPs) and liposomal drug products present unique analytical challenges due to their structural complexity and sensitivity to formulation and processing conditions.Regulatory guidance from the FDA, EMA, and USP highlights critical quality attributes (CQAs) such as particle size, surface charge, morphology, and encapsulation efficiency as essential for ensuring product quality, consistency, and performance.This webinar introduces field-flow fractionation coupled with multi-angle light scattering (FFF-MALS) as a powerful platform for comprehensive LNP and liposome characterization. We will review the fundamental principles of FFF-MALS and demonstrate how the technique enables size-resolved measurement of key CQAs while preserving native particle structure. Practical guidance on method development, implementation, and best practices will be shared to help achieve robust, reproducible, and regulatory-relevant results.<h4>Top 3 Key Takeaways:</h4><ul><li>Review recent and upcoming regulatory changes affecting LNP and liposomal drug CQAs</li><li>Learn how FFF‑MALS can address critical quality attributes</li><li>Discover resources and practical tips for implementation</li></ul><h4>Who should attend?</h4>This webinar is designed for you if you are a scientist, analyst, or lab manager working on vaccine, LNP, or liposome characterization, or if you are part of a CDMO, CRO, or testing organization looking to expand analytical capabilities.<blockquote>Presenter: Nemal Gobalasingham, Ph.D. (Product Manager, Waters | Wyatt Technology)Nemal Gobalasingham is a Product Manager for the Eclipse FFF system and DAWN MALS instrument line. He joined Wyatt Technology in 2018 as an Application Scientist and works closely with customers across a broad range of fields to provide application support and training. Nemal also serves as the Global Training Manager, overseeing and developing Wyatt’s field staff training programs. He earned a B.S. in Chemistry from Syracuse University and a Ph.D. in Chemistry from the University of Southern California, where his research focused on semiconducting polymers and materials science.Presenter: Udayabagya (Bud) Halim (Sr. Marketing Analyst, Waters | Wyatt Technology)Bud Halimis a senior marketing analyst at Waters | Wyatt Technology with a PhD in physical chemistry from UCLA. He began his career teaching biochemistry and chemistry and contributing to laboratory manuals before transitioning into the scientific instrumentation industry as an applications scientist. At Waters, he supports researchers in the characterization of peptides, biologics, lipid nanoparticles (LNPs), and viral vectors.</blockquote></div>

Waters Corporation: Navigating Regulatory Guidance for LNP and Liposomal Drug Characterization Using FFF-MALS

Navigating Regulatory Guidance for LNP and Liposomal Drug Characterization Using FFF-MALS

Discover how FFF-MALS supports regulatory-ready characterization of LNPs and liposomes by resolving key CQAs like particle size, structure, and consistency.

Regulatory Guidance for LNP and Liposomal Drug By FFF-MALS

<div>Smarter Bioanalysis: Driving Consistency and Efficiency in Today’s Labs Discovery and regulated bioanalysis labs strive for simplicity, consistency, robustness and operational efficiency to maximize impact and resource utilization. Optimizing every step of the bioanalytical workflow is key to developing assays that perform consistently over time. As therapeutic modalities continue to evolve, so do the needs of bioanalytical laboratories.In this webinar, Dr. Basile Khara from Alderley Analytical (now a part of Synexa Life Sciences) shares his experiences on how out-of-the-box performance of detergent-free OligoWorks™ SPE Microplate Kit, combined with a robust analytical platform like the Xevo TQ Absolute XR Mass Spectrometer and waters_connect for quantitation software simplifies bioanalytical workflows.<h4>What you’ll walk away with</h4><ul><li>How OligoWorks™ SPE Microplate Kit simplifies oligonucleotide sample preparation</li><li>The implications of having a robust analytical platform that shows consistent performance even after 30,000 injections or protein precipitated plasma</li><li>A simplified, compliant ready informatics platform can streamline data review and help you get to decisions faster</li></ul><h4>Who should attend?</h4>This webinar is designed for you if you are a Research Associate, Scientist, Director, or Lab Manager in pharma, biopharma, biotech, or CROs involved in bioanalysis.Don't miss it.<blockquote>Presenter: Dr. Basile Khara (Principal Scientist, Alderly Analytical (Part of Synexa Life Sciences))Basile Khara is currently the Principal Scientist in the method development team at Alderley Analytical situated in Macclesfield U.K, part of Synexa Life Science Ltd. His leading role focuses on the design and validation of novel LC-MS bioanalysis methods that specifically target chemical entities such as oligonucleotides, proteins and conjugated peptides.Overall, he has accumulated over ten years’ worth of LC-MS quantification and characterization experience in pre-clinical drug discovery and clinical bioanalysis, along with a Ph.D. in chemistry from the University of Manchester.</blockquote></div>

Waters Corporation: Bioanalysis simplified – A case study with Basile Khara

Bioanalysis simplified – A case study with Basile Khara

How OligoWorks™ SPE Microplate Kit simplifies oligonucleotide sample preparation.

Bioanalysis simplified – A case study

<div><h4>Navigating Challenges and Opportunities for Environmental Testing Labs Under the Revised EU Water Framework Directive</h4>The European Commission’s proposed updates to the Water Framework, Groundwater, and Environmental Quality Standards Directives are bringing new responsibilities and opportunities for environmental testing labs. With expanded pollutant lists - including PFAS, pharmaceuticals, and pesticide metabolites - and stricter monitoring and reporting requirements, the landscape of water analysis is rapidly evolving.Join the 4th Waters Environmental Webinar Series to explore how your lab can navigate these challenges and turn regulatory change into opportunity.Register for free and partner with us to shape the future of European water quality.<h5>Why Attend</h5>Stay ahead of new EU regulatory demands with insights from leading experts. Gain practical guidance, share experiences with peers, and prepare your lab for the next generation of water quality standards.<h5>Highlights</h5><ul><li>New pollutant categories and analytical challenges</li><li>Updates to monitoring protocols and reporting</li><li>Innovative methods to meet revised Environmental Quality Standards</li><li>Strategic guidance for compliance and adaptation</li></ul>Lead the change in water analysis—stay ahead, stay compliant, and make a real impact.<h4>EPISODE 3: Master the challenging EQS values for endocrine active compounds</h4><h4>What you Will Learn</h4><ul><li>How a sensitive LC-MS/MS supports the detection of estrogens in different water types</li><li>How to develop a method for BPA and further bisphenols in environmental samples</li></ul></div>

Master the challenging EQS values for endocrine active compounds

How a sensitive LC-MS/MS supports the detection of estrogens in different water types

Challenging EQS values for endocrine active compounds

Gain insights into comprehensive characterization of monoclonal antibodies using SCIEX high-resolution mass spectrometry (HRMS) platforms. This webinar will highlight advanced analytical workflows for accurate identification, structural characterization, and quality assessment of monoclonal antibodies across different development stages. Learn how SCIEX HRMS solutions enable high sensitivity, confidence, and efficiency to support biotherapeutic research, development, and quality control.<h4>Key highlights:</h4><ul><li>Zeno trap for higher sensitivity</li><li>Alternate fragmentation using EAD</li><li>Case studies</li></ul><blockquote>Speaker: Rishikesh T V, Application Support Specialist</blockquote>

SCIEX: Comprehensive characterization of monoclonal antibodies using SCIEX HRMS platforms

Comprehensive characterization of monoclonal antibodies using SCIEX HRMS platforms

Webinar on monoclonal antibody characterization with SCIEX HRMS, highlighting Zeno trap sensitivity and EAD fragmentation workflows.

Characterization of monoclonal antibodies by SCIEX HRMS

Antibody-oligonucleotide conjugates (AOCs) represent an emerging class of biotherapeutics that merge the precision and low toxicity of oligonucleotide drugs with the high specificity of antibodies. These conjugates typically consist of an antisense oligonucleotide (ASO) or siRNA linked to an antibody via cleavable or noncleavable linkers. Characterizing AOCs using liquid chromatography poses unique challenges, including sequence confirmation, oligonucleotide-to-antibody ratio (OAR) measurement, conjugation site identification, and impurity assessment. This webinar will showcase complementary LC-MS methods developed to characterize AOCs composed of a trastuzumab biosimilar conjugated with siRNA or ASO.<h4>Key Learning Points</h4><ul><li>Understand the structure of an antibody-oligo conjugate (AOC) and its components.</li><li>Identify the analytical requirements and challenges of AOC characterization.</li><li>Explore LC with MS and UV strategies for AOC characterization.</li></ul><h4>Who Should Attend</h4><ul><li>Any scientists performing analytical LC method development for siRNA or ASO Oligo conjugate characterization</li></ul><blockquote>Speaker: Roxana Eggleston-Rangel (Senior Applications Scientist, Phenomenex)Roxana joined Phenomenex in 2018 as an Applications Scientist and is currently working with the applications team to produce analytical solutions for the biopharma industry. Her current work focuses on characterization of mRNA, sgRNA and siRNA. Prior to Phenomenex, Roxana worked for Caltech and the University of Southern California developing LM-CS workflows for the proteomics community. She received her bachelor’s and master’s degree in Chemistry and Biochemistry from California State University, Los Angeles.</blockquote>

Phenomenex: Characterizing Antibody-Oligonucleotide Conjugates (AOCs) Under Native and Reversed-Phase Conditions

Characterizing Antibody-Oligonucleotide Conjugates (AOCs) Under Native and Reversed-Phase Conditions

This webinar will showcase complementary LC-MS methods developed to characterize AOCs composed of a trastuzumab biosimilar conjugated with siRNA or ASO.

Antibody-Oligonucleotide Conjugates Under Native and RP

The aromatic profile of Trigonella caerulea (blue fenugreek) develops predominantly after harvest, yet its detailed chemical characterization has long been limited by analytical challenges associated with highly volatile and low-abundance compounds. In this study, conventional GC–MS headspace analysis was complemented by high-resolution GC–MS employing cyanopropyl-functionalized stationary phases to improve compound separation and identification.While standard GC–MS enabled the detection of major volatile aldehydes and monoterpenoids, high-resolution GC–MS proved essential for resolving co-eluting compounds and identifying very volatile aroma constituents with greater confidence. In parallel, non-volatile α-keto acids were quantified by LC–MS to provide a comprehensive view of aroma precursors.Comparative analysis demonstrates that high-resolution GC–MS significantly enhances analytical depth and accuracy, allowing a more complete understanding of aroma formation dynamics during drying and storage. These results underline the critical role of advanced chromatographic techniques in elucidating complex herbal aroma systems.<h4>Learning points:</h4><ul><li>Analytical resolution matters: High-resolution GC–MS provides superior chromatographic separation and compound identification compared to conventional GC–MS, enabling reliable detection of highly volatile and low-abundance aroma compounds that would otherwise remain unresolved.</li><li>Method choice shapes interpretation: The apparent aromatic profile of Trigonella caerulea depends strongly on the analytical technology used, with advanced GC–MS approaches revealing a substantially higher chemical complexity than standard methods.</li><li>Integrated analytics are essential: Combining high-resolution GC–MS for volatile compounds with LC–MS for non-volatile aroma precursors allows a more complete understanding of aroma formation dynamics during drying and storage.</li></ul><h4>Who should attend?</h4><ul><li>Analytical chemists and method developers&nbsp;</li><li>Food, flavor, and fragrance scientists&nbsp;</li><li>Natural products and phytochemistry researchers&nbsp;</li></ul>If you cannot attend this webinar please register to receive a link to the On Demand version the following day.<blockquote>Presenter: Dr. Thomas Stegemann (Lab Manager and group leader, Christian-Alberts-University Kiel)Thomas has a Dr. in pharmacy, deep GC and GC/MS knowledge and combines both assets working for the University in cooperation with Pharma companiesPresenter:&nbsp;Petra Gerhards (Regional Marketing Manager, EMEA, AAT, Thermo Fisher Scientific)</blockquote>

Thermo Fisher Scientific: Aromatic profiling using GCMS and HRGCMS

Aromatic profiling using GCMS and HRGCMS

Learn how HRMS GC–MS and LC–MS improve characterization of blue fenugreek aroma compounds and reveal complex flavor formation during drying and storage.

<h5>In this webinar, you will learn:</h5><ul><li>How the regulatory landscape is evolving to support sustainable approaches with respect to 3Rs in biosafety testing</li><li>How a roadmap can be employed to drive replacement, reduction and refinement of the use of animals in quality control testing&nbsp;</li><li>How the introduction of sustainable, alternative methods can help to drive reduced timelines for cell line characterization&nbsp;</li><li>About recently published data supporting the use of Next Generation Sequencing for replacing in vivo testing for adventitious virus detection</li></ul><h5>Detailed description:</h5>With many technological advances in biologics safety testing, non-animal alternatives to classical animal tests have been developed, providing a foundation for a growing number of regulatory changes, which in turn provide a supportive framework for a 3Rs (replace, reduce, refine) approach in biologics safety testing.In this webinar, we review the regulatory landscape and explore an approach to developing 3Rs roadmaps. We present recently published data demonstrating the value of next generation sequencing (NGS) as a replacement for in vivo testing for adventitious viruses, and discuss implementing the latest technologies, including NGS, in a faster cell line characterization package.&nbsp;An on-demand version of this webinar will be available after the live event using the same link. Register now and access the webinar at your convenience.<blockquote>Presenter: Sarah Sheridan, PhD (Senior Technical Consultant)Dr Sarah Sheridan, Senior Technical Consultant at our company, provides scientific, technical and regulatory consultancy within the BioReliance® Biosafety Testing business. Drawing on over 30 years of experience in the biotech industry, Dr Sheridan provides biosafety testing consultancy for the company’s global client base to support pre-clinical to commercial phase biosafety testing of client manufactured products spanning monoclonal antibodies to vaccines and novel gene therapies. Dr Sheridan has a Ph.D. in Veterinary Virology from the University of Cambridge, UK and a B.Sc. Honours degree in Life Science.Presenter:&nbsp;Anna Woodward, PhD (Technical Consultant)Anna Woodward joined the organization in 2019 and has 20 years’ experience providing technical support to developers and manufacturers of small molecules and biologics. In her current role as a Technical Consultant, Anna supports the BioReliance® services portfolio and works closely with clients and internal colleagues to provide scientific and regulatory guidance on biosafety testing packages. Anna holds a PhD in cell biology from the University of Dundee, Scotland.</blockquote>

Merck: Innovate and Accelerate: Leveraging 3Rs for Superior Cell Line Characterization

Innovate and Accelerate: Leveraging 3Rs for Superior Cell Line Characterization

In this webinar, we review the regulatory landscape and explore an approach to developing 3Rs roadmaps. 

3Rs for Superior Cell Line Characterization

When titration results fall out of specification, resolving the chemistry is only part of the solution. In regulated pharmaceutical laboratories, it is equally critical to demonstrate control over the workflow that produced the result.Unexpected OOS (out of spec) often stem from subtle but significant factors like electrode performance issues, matrix interferences, or poorly optimized Karl Fischer parameters. In this case study focused mini course, Eduardo Simões, Titration Product Specialist, walks through the most frequent pitfalls encountered in potentiometric and Karl Fischer analyses and demonstrates practical, standards aligned strategies to correct them at the bench.Building on these corrective actions, Martin Kobler, Senior Product Specialist for Software, demonstrates how compliant digital controls ensure those improvements are consistently applied and defensibly documented. Through structured user roles, controlled method versioning, secure review workflows, and a comprehensive audit trail, participants will see how software transforms troubleshooting into a repeatable, inspection ready process.Participants will gain a clear framework for preventing recurring deviations, strengthening data integrity, and maintaining inspection-ready titration workflows. Stick around for a live Q&amp;A to explore how these strategies apply to your own titration challenges.<h4>Please plan to attend if you want to: </h4><ul><li>Identify KF and potentiometric failure modes and apply compendial‑aligned corrective actions</li><li>Connect analytical troubleshooting steps to compliant software controls and audit trail documentation Implement best practices that improve method robustness and consistency in a GxP environment</li></ul><h4>Key Learning Points</h4><ul><li>Identify the primary causes of out-of-specification titration results.</li><li>Apply practical, standard-aligned corrective actions for potentiometric and KF analyses.</li><li>Understand how digital controls strengthen data integrity through role management, version control, and secure review workflows Learn how software tools create defensible, audit‑ready documentation.&nbsp;</li></ul><blockquote>Presenter: Martin Kobler (Sr. Product Specialist, Software, Metrohm USA)Martin Kobler is the Senior Product Specialist for Software at Metrohm USA where he supports the OMNIS platform and its integration across laboratory environments. Based in Riverview, Florida, he works within the Marketing – Product Management department and collaborates closely with product teams, technical specialists and customer-facing groups to guide software adoption and ensure users can fully leverage OMNIS capabilities.With extensive experience supporting Metrohm’s digital solutions, Martin provides expert instruction on software functions, compliant workflows and method execution. His background includes deep familiarity with customer needs and hands-on guidance that helps laboratories transition smoothly to modernized, secure and audit-ready software ecosystems. He is frequently engaged in internal training, live demos and cross-functional initiatives to strengthen software proficiency across the organization.He is based in Riverview and can be reached through his Metrohm USA contact channels.Presenter: Eduardo Simões (Titration Product Specialist, Metrohm USA)As the Titration Product Specialist at Metrohm USA in Riverview, Florida, Eduardo Simoes, MSc, leverages 22 years of practical experience in potentiometry and electroanalysis. His expertise spans instrument installations, technical support, and training, gained through extensive field work. He holds bachelor's and master's degrees in analytical chemistry from the University of Campinas, Brazil, providing a strong theoretical foundation for his hands-on approach.</blockquote>

Metrohm: From Out-of-Spec Results to Audit-Ready: Controlling Titration in GxP Labs

From Out-of-Spec Results to Audit-Ready: Controlling Titration in GxP Labs

Master KF and potentiometric titration troubleshooting and discover how software workflows improve data integrity, method robustness, and audit readiness.

Controlling Titration in GxP Labs

<div><div container-id="cq-colctrl-lt0" comp-id="A1"><div>The gold standard of quality assessment of drugs is nowadays an HPLC using a reversed-phase (RP) column chromatography and aqueous buffers, acetonitrile, and/or methanol as mobile phase, combined with a UV detector.As many excipients and active pharmaceutical ingredients (APIs) do not have a chromophore, these compounds are not suitable for identification and quantification by UV detection. In this situation, the near-universal Charged Aerosol Detector (CAD) is an excellent alternative capable of detecting almost all non-volatile compounds.One critical thing to know is that the mobile phase composition—often dictated by solid phase chemistry—can influence the CAD response. In addition to RP techniques, chromatographers often apply ion pair chromatography (IPC), mixed mode (MMC), and hydrophilic interaction (HILIC) methods. We will discuss how these solid phases influence selectivity and sensitivity of the CAD when analyzing the purity of APIs such as amino acids, vigabatrin, ibandronate, atropine, and gabapentin, as well as excipients, e.g., fatty acids, PEGs, and polysorbates.These examples will demonstrate the versatility of HPLC-CAD for quantifying low concentrations of impurities in APIs and excipients. Sensitivity is of great importance in the quality control of drugs.<h4>Key Learning Objectives:</h4><ul><li>Quality assurance by HPLC-CAD, enhancement of sensitivity, impurity profiling of APIs and excipients.</li></ul><h4>Key learning and takeaways include:</h4><ul><li>Explore on the critical yet increasingly complex challenge of impurity profiling of APIs and excipients in pharmaceutical analysis</li><li>Review on enhancement of sensitivity in detection to uncover low-level impurities</li><li>Discover examples for quality assurance by HPLC-CAD analysis</li></ul><blockquote>Presenter: Ulrike Holzgrabe (Senior-Professor Pharmaceutical and Medicinal Chemistry, University of Würzburg)Ulrike Holzgrabe holds a diploma in Chemistry and an approbation in Pharmacy. After habilitation in Kiel she became a professor of Pharmaceutical Chemistry at the University of Bonn and from 1999 till 2022 she holds a chair of Pharmaceutical and Medicinal Chemistry in Würzburg. She served for some 25 years as an expert of the German pharmacopoeia commission (at BfArM) and for 18 years as an expert and president of two expert groups at the European Directorate of the Quality of Medicines and HealthCare (EDQM). She has published 500+ papers in the field of quality assurance of drugs and medicinal chemistry.Presenter:&nbsp;Frank Steiner (Senior Manager of Product Applications, Thermo Fisher Scientific)Frank Steiner is the Senior Manager of Product Applications and helps coordinate scientific collaborations at Thermo Fisher Scientific. He received his Ph.D. in Analytical Chemistry from Saarland University in Saarbrücken, Germany, and has published 30+ publications in refereed journals and 10+ textbook chapters on HPLC topics.</blockquote></div></div></div>

Thermo Fisher Scientific: Why HPLC-CAD is ideal for quality assurance of APIs and excipients

Why HPLC-CAD is ideal for quality assurance of APIs and excipients

Learn how HPLC-CAD improves impurity profiling of APIs and excipients with higher sensitivity and near-universal detection for pharmaceutical quality assurance.

HPLC-CAD for quality assurance of APIs and excipients

<div><div container-id="cq-colctrl-lt0" comp-id="A1"><div>Looking to further elevate your Thermo Scientific Chromeleon CDS skills? Want to learn more about the administration tools for your Chromeleon software setup? Already attended <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/5981">Administration Console I webinar (tips, shortcuts, and user/access management)</a>? Part II is the next step – focused on system-level management, structured resources, and automation across your Chromeleon software environment.In this practical session, we’ll dive into more Administration Console capabilities that help you manage and standardize your setup at scale – from Data Vault configuration and Chromeleon Resources to eWorkflows and automated rollout of updates. You’ll leave with proven approaches for keeping multi-station environments consistent, controlled, and easier to support.<h4>What’s different in Part II (vs. <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/5981">Part I</a>):</h4><ul><li>Beyond users &amp; permissions: Shift from access management to managing Chromeleon Resources and system components.</li><li>System structure &amp; governance: Learn how Data Vaults support secure, controlled data handling and standardized operations.</li><li>Remote administration: Explore methods for remotely updating Chromeleon Stations and reducing manual touchpoints.</li><li>Real-world best practices: Practical guidance to help maintain stability, security, and compliance as environments grow.</li></ul><h4>Who should attend:</h4>This session is designed for anyone wanting to learn more about administration of Chromeleon CDS, administrators, lab IT/support teams, and power users who want to take on administration responsibilities – especially those supporting multiple stations or managing standardized deployments.Get practical, immediately usable techniques to keep your Chromeleon software setup scalable, consistent, and supportable – with less manual effort and fewer surprises.Cannot attend the broadcast on March 26? Please register anyway to automatically receive the link to the recording.<blockquote>Presenter: Pascal Bächli (Sr. Engineer, Field Applications • Analytical Instrruments Group, Thermo Fisher Scientific)Pascal Bächli is a Sr. Field Application Engineer at Thermo Fisher Scientific with over 12 years of laboratory experience in both GMP and non-GMP environments. He specializes in the administration, implementation, and support of laboratory data systems, including Thermo Scientific Chromeleon CDS and Waters Empower. He supports networked Chromeleon software installations, delivering consulting and user training, and troubleshooting for complex technical and workflow issues.Pascal also holds a degree in Business IT, complementing his strong lab background and scientific expertise with deep knowledge of digital systems and business processes. This combination allows him to bridge the gap between the practical challenges scientists face and available technology to deliver efficient and compliant laboratory data solutions.</blockquote></div></div></div>

Thermo Fisher Scientific: Chromeleon Admin Console II: System management and automation

Chromeleon Admin Console II: System management and automation

In this practical session, we’ll dive into more Administration Console capabilities that help you manage and standardize your setup at scale