This leaflet is intended to help participants in quantitative proficiency testing (PT) schemes to better understand the performance assessment made by the PT provider [1-4].<h3>Performance assessment parameters&nbsp;</h3><h4>Assigned value&nbsp;</h4>In order to assess individual performances, the results reported by participants are compared to the value assigned by the PT provider (xpt). ISO 13528 [1] suggests five different ways to obtain xpt (Figure 1). In this context, the design of the PT scheme must reflect the objectives of the scheme, comparing results either to a predetermined xpt (independent from the participant results), or to a value derived from the reported results. The PT provider is responsible for defining xpt , taking into account the advantages and disadvantages of the various possibilities when establishing metrological traceability or estimating the uncertainty of the assigned value, u(xpt).<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Eurachem_Figure_1_e5ef5d1f9c.jpg" alt="Eurachem - Figure 1 Options for obtaining the assigned value, Xpt" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Eurachem_Figure_1_e5ef5d1f9c.jpg 245w," sizes="100vw" width="640" height="382"><h4>Uncertainty of the assigned value&nbsp;</h4>The uncertainty of the assigned value u(xpt) can be estimated in at least five different ways [1], each corresponding to the value assignment strategy illustrated in Figure 1. The different uncertainty evaluation methods are listed in Figure 2. This uncertainty can be reported as a standard uncertainty (u (xpt)), or as an expanded uncertainty U (xpt) with a coverage factor k, where U (xpt) = k . u (xpt). The choice of k will impact the level of confidence (e.g. approximately 95 % for k = 2).<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Eurachem_Figure_2_f41ebc0c61.jpg" alt="Eurachem: Figure 2 Options for obtaining the uncertainity of the assigned value, u(Xpt)" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Eurachem_Figure_2_f41ebc0c61.jpg 245w," sizes="100vw" width="727" height="378"><h4>Standard deviation for proficiency assessment&nbsp;</h4>Five possibilities are suggested by ISO 13528 to set the standard deviation for proficiency assessment spt (Figure 3). The chosen approach must comply with the objectives of the PT scheme.&nbsp;<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Eurachem_Figure_3_f09cb3969e.jpg" alt="Eurachem: Figure 3 Options for obtaining the standard deviation for proficiency assesment" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Eurachem_Figure_3_f09cb3969e.jpg 245w," sizes="100vw" width="638" height="355">Two approaches for performance assessments use spt as shown in Table 1.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Eurachem_Table_1_Scoring_for_performance_assessment_3dd03aa3fb.jpg" alt="Eurachem: Table 1 - Scoring for performance assessment." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Eurachem_Table_1_Scoring_for_performance_assessment_3dd03aa3fb.jpg 245w," sizes="100vw" width="1390" height="571"><h3>Performance assessment&nbsp;</h3>All performance assessments are based on the difference between the participant’s results (xi) and the assigned value (xpt) divided by a normalisation factor (Table 1).&nbsp;<ul><li>The percent difference D% is the normalised difference expressed as a percentage of xpt , for which a prescribed maximum relative permissible error (dE% = dE / xpt) is defined by the PT provider.&nbsp;</li><li>The z score (unitless) compares the participant’s deviation from the assigned value with the standard deviation for proficiency assessment (spt). When the uncertainty of the assigned value is significant (u(xpt) &gt; 0.3 spt), the z’ score should be used instead, to include the contribution of u(xpt) in the denominator.&nbsp;</li><li>The zeta (ζ) score (unitless) states whether the laboratory’s result agrees with the assigned value within the respective uncertainty. The denominator is the combined (standard) uncertainty of the assigned value u(xpt) and the (standard) measurement uncertainty reported by the laboratory u(xi). An unsatisfactory zeta score can either be caused by an inappropriate estimation of the measured quantity value (e.g. concentration, content), or of its measurement uncertainty, or both.&nbsp;</li><li>The En score (unitless), unlike the zeta score, uses a combination of expanded uncertainties as the normalisation factor. This combination corresponds to a confidence interval of approximately 95 %. En scores are often used in metrology comparisons among calibration laboratories.</li></ul><h3>Interpretation of performance scores&nbsp;</h3>According to ISO 13528:2022 clause 9.4.2, the conventional interpretation of the z, z’ and ζ scores is as follows:&nbsp;<ul><li>A result that gives |score| ≤ 2.0 is considered to be acceptable, indicating satisfactory performance.&nbsp;</li><li>A result that gives 2.0 &lt; |score| &lt; 3.0 is considered to give a warning signal, indicating questionable performance.&nbsp;</li><li>A result that gives |score| ≥ 3.0 is considered to be unacceptable (or action signal), indicating unsatisfactory performance.&nbsp;</li></ul>Similarly, |En| &lt; 1 and |D%| &lt; dE% indicate successful (acceptable) performance.

Understanding PT performance assessment

The increasing focus on nitrosamine impurities has prompted analytical development teams across the industry to revisit long-standing assumptions about sensitivity, selectivity, and method versatility. Among the impurity classes now receiving heightened attention are nitrosamine drug substance–related impurities (NDSRIs), a group distinguished by their structural resemblance to parent APIs and their tendency to form under specific manufacturing or storage conditions. For beta blockers, which often contain amine functionalities susceptible to nitrosation, this presents a particularly relevant analytical challenge.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Thermo_Fisher_Scientific_Exploring_a_Versatile_LC_HRMS_Strategy_for_NDSRI_Determination_in_Beta_Blocker_Drug_Substances_d824f864cd.jpg" alt="Thermo Fisher Scientific: Exploring a Versatile LC–HRMS Strategy for NDSRI Determination in Beta Blocker Drug Substances" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Thermo_Fisher_Scientific_Exploring_a_Versatile_LC_HRMS_Strategy_for_NDSRI_Determination_in_Beta_Blocker_Drug_Substances_d824f864cd.jpg 245w," sizes="100vw" width="1024" height="512">A recent <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/labrulez-bucket-strapi-h3hsga3/an_003910_pb_lc_hrms_beta_blocker_ndsri_an003910_na_en_61a31cd182.pdf">Thermo Fisher Scientific application note</a> examines this challenge through the lens of LC–HRMS, presenting a unified analytical approach capable of addressing NDSRI quantitation across six different beta blocker drug substances.<h3>Revisiting the complexity of NDSRIs</h3>The scientific and regulatory landscape surrounding NDSRIs continues to evolve. As outlined early in the study (pages 2–3), the scarcity of toxicological data for many of these impurities has led agencies to adopt structure-based frameworks such as the Carcinogenic Potency Categorization Approach (CPCA). These classifications, coupled with low acceptable-intake values, have placed new emphasis on achieving both trace-level sensitivity and high structural specificity.For many labs, that means rethinking the interplay between chromatographic separations, ionization behavior, adduct formation, and mass accuracy, especially when the impurity under investigation differs only subtly from its corresponding drug substance.<h3>A single method across six APIs</h3>One aspect of the work that may be of interest to analytical scientists is the decision to pursue one LC–HRMS method applicable across six beta blocker drug substances: atenolol, bisoprolol fumarate, carvedilol, labetalol HCl, metoprolol fumarate, and propranolol HCl.This required careful consideration of:<ul><li>Column chemistry and dimensions</li><li>Mobile phase composition and gradient design</li><li>Ion source settings suitable for diverse analyte structures</li><li>Product ion selection guided by theoretical fragmentation analysis (pages 6–8)</li><li>Valve switching to manage potential interferences</li></ul>The resulting method offers a perspective on how unified analytical strategies may help streamline workflows in environments where multiple drug substances must be assessed for similar impurity risks.<h3>Method performance: key observations</h3>The study presents a series of experimental evaluations, reproducibility, robustness, linearity, recovery, and ion-ratio confirmation, that provide insight into how the method behaves under different analytical conditions.A few noteworthy observations include:<ul><li>Linearity (R² &gt; 0.99 for all NDSRIs): Calibration plots (page 11) illustrate consistent detector response across a broad concentration range.</li><li>Sensitivity at low levels: LOQs aligned to 10% of each impurity specification limit (Table 14, page 10), with LODs at approximately one-third of the LOQ.</li><li>Long-run robustness: A 21-hour sequence showed stable peak-area performance, with cumulative %RSD values that speak to the system’s suitability for extended runs (page 9).</li><li>Chromatographic clarity: Representative chromatograms (pages 13–14) demonstrate distinct separation between NDSRIs and their related APIs, even within a 20-minute gradient.</li></ul>These results collectively provide a framework for understanding how LC–HRMS can be optimized for structurally similar, low-level impurities in complex matrices.<h3>Key considerations</h3>While every laboratory faces unique constraints, sample types, regulatory expectations, and throughput demands, the work offers several themes that may resonate with teams currently evaluating or refining nitrosamine methodologies:<ul><li>The emphasis on accurate mass and interference avoidance highlights the value of high-resolution MS when dealing with closely related structures.</li><li>The method’s consistency across structurally diverse beta blockers underscores how column and gradient design influence versatility.</li><li>The detailed precursor and product ion selection process illustrates a practical approach to balancing sensitivity and selectivity in impurity analysis.</li></ul>These elements, taken together, form a basis for discussion as laboratories consider how best to adapt their workflows to emerging impurity requirements.<h3>A closer look at the study</h3>For those interested in the nuances of CPCA-driven specification setting, chromatographic optimization, or the application of <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products?category=134&amp;manufacturerItems=3">Orbitrap-based mass spectrometry</a> to low-level impurity work, the full application note provides additional technical depth. It includes complete parameter tables, ion-ratio confirmation data, chromatographic profiles, and experimental rationales that further illuminate the method’s development and evaluation.<blockquote>Visit us on&nbsp;<a target="_blank" rel="noopener noreferrer" href="https://www.linkedin.com/showcase/72003132/admin/dashboard/">LinkedIn:</a>&nbsp;#NitrosamineImpurities #NDSRI #NitrosamineAnalysis #ImpurityAnalysis</blockquote>

Exploring a Versatile LC–HRMS Strategy for NDSRI Determination in Beta Blocker Drug Substances

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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.

Eurachem

The International Symposium on Chromatography (ISC) represents the oldest conference series focussing on separation science. ISC symposia have been organised since 1956 in each even year. ISC is internationally recognised as one of the premier meeting series for discussion of all modes of chromatography and separation science with a broad coverage of techniques and applications.

International Symposium on Chromatography - (ISC)

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Agilent Technologies

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Phenomenex

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Waters Corporation

<h4>Tackle Real Workflows for Complex Bioanalysis Challenges</h4><ul><li>Working in DMPK?</li><li>Curious how modern software is making workflows for new modalities easier?</li></ul>We’re excited to invite you to DMPK in Action, a new 3-part webinar series designed for &nbsp;bioanalysis scientists that brings real workflows to your screen through practical demonstrations of our system and software.<h5>See real DMPK workflows in action - designed for the challenges of modern, complex therapeutics.</h5>In short 30 min sessions, we’ll show real workflows, with a focus on practical applications, efficiency, and how DMPK scientists can move from sample to result with greater confidence.<h5>Episodes</h5><ul><li>Explore the DMPK workflow in action</li><li>From Sample to Result</li><li>Data handling and analysis with confidence</li></ul><h5>Why you should attend</h5>Each session shows how our system and software support practical DMPK tasks, improve visibility, and help teams work more efficiently.<h5>You'll see:</h5><ul><li>Real DMPK workflow demonstrations.</li><li>Practical use cases for bioanalysis scientists.</li><li>How our system and software support consistency, reliability, and efficiency.</li></ul><h5>Who should attend</h5>If you’re involved in DMPK, bioanalysis, or ADME workflows, this series is designed to give you a clear look at how the process works in practice, delivered straight to your officeCan't attend the webinars live? Register today and watch the episodes on-demand at your convenience.<blockquote>Speaker: Antonia Wierzbicki (Principal MS Market Dev Manager, EMEA, Waters Corporation)Antonia Wierzbicki is a MS market development manager at Waters working in EMEA. Antonia has BSc in Pharmaceutical Science and a MSc in Cancer Pharmacology.Following several years working as an analytical chemist in drug development roles within both academic labs and contract research organizations, Antonia has more recently spent time working with analytical chemists to provide solutions using cutting edge technologies to meet their needs and requirements, with a specific interest in ultra-sensitive quantitation of small molecules.Antonia is based in Cambridge UK and keen to connectwith like-minded scientists in the field.Speaker: Henry Foddy (Associate Scientist, Waters Corporation)Henry is a Scientist in the Routine Mass Detection Team at Waters, working on applications to support Waters’ single quadrupole portfolio that span a variety of market segments. He has almost 3 years of experience with Waters, working previously in a food and environmental role support regulatory testing of Pesticides, PFAS, and Pyrrolizidine Alkaloids. Prior to joining Waters, Henry obtained an MSc in Neuroscience from King’s College London.</blockquote>

DMPK: From Sample to Result

Join Waters webinars on DMPK bioanalysis workflows, data handling, and modern software tools supporting efficient ADME and bioanalysis applications.

<div>Two Powerful Detectors, One Complete Picture:MALS and MS for GLP-1RA CharacterizationWhich advanced detector should you use for GLP-1 receptor agonists - and when?This webinar explains how multi-angle light scattering (MALS) and mass spectrometry (MS) provide complementary insights into GLP-1RA quality.<h5>What You'll Learn:</h5>Learn when to use SEC-MALS for direct molar mass and oligomer quantitation in solution, and when RPLC-MS is essential to confirm molecular identity and detect chemical variants.Through practical examples, discover how these orthogonal techniques strengthen CQA assessment, improve analytical confidence, and guide effective column selection for separation.The session also highlights compliant, integrated workflows using Empower Chromatography Data System.<ul><li>Choose the right detector with confidence: Understand when to use MALS for oligomer and aggregation analysis and when MS is essential for confirming molecular identity and chemical variants.</li><li>Accelerate method development with the right column: Learn practical SEC and RPLC column selection strategies, plus resources to help you get started quickly.</li><li>Discover the latest capabilities in Empower Software: Simplify SEC-MALS and MS workflows, improve efficiency, and support compliant data analysis.</li></ul>Reserve Your Spot Today!This webinar is designed for Scientists, Analysts, and Lab Managers in Discovery, Development, Quality Control, or Analytical Services who characterize synthetic peptides, CDMOs, CROs and other testing organization who are interested in expanding their capabilities &nbsp;<blockquote>Speaker: Udayabagya (Bud) Halim (Sr. Product Marketing Analyst, Waters Corporation)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: Which Detector Do You Need for GLP-1RAs? Choosing Between MALS and Mass Spec

Which Detector Do You Need for GLP-1RAs? Choosing Between MALS and Mass Spec

Master GLP-1RA characterization. Discover when to use SEC-MALS for aggregation analysis and when RPLC-MS is essential to confirm molecular identity

MALS and MS for Advanced GLP-1RA Characterization

Discover how today’s advanced peptide technologies are shaping tomorrow’s research, development, and manufacturing success.<h5>In this symposium, you'll learn about:</h5><ul><li>Scalable peptide API manufacturing and purification expertise for GLP‑1 class molecules</li><li>Label‑free, real‑time cell‑based bioassays for peptide activity, optimization, and safety testing</li><li>Non‑destructive Raman raw material identification through opaque containers to streamline GMP workflows</li><li>Inert LC/MS strategies for enhanced peptide separation, impurity profiling, and molecular weight confirmation</li></ul>This digital symposium explores the innovations shaping the future of peptide‑driven science, featuring modern analytical tools across cell analysis, chemistries, spectroscopy, and mass spectrometry. Experts will reveal practical approaches for integrating these technologies to strengthen and streamline peptide analysis.Attendees will gain a clear view of emerging technologies and practical strategies across modern research and applied science. Join the symposium to discover how to connect these advances directly to your own work.10:00 - 10:05 - IntroVitan Blagotinsek, Agilent Technologies10:05 - 10:20 - Highlight Talk - Scaling the GLP-1 Surge: Peptide API Development, Purification and Manufacturing at AATWolfgang Schiek, BioVectraAs the paradigm shift in diabetes management and the surge in anti-obesity drug sales and development are propelling unprecedented demand for complex peptide APIs therapies, reliable high quality peptide API manufacturing and purification are critical. Agilent Advanced Therapeutics provides specialized expertise and scaling capacity for these GLP-1 Agonists. We support our customers from preclinical to commercial through swift, customer-focused implementation in state-of-the-art facilities and are continuously expanding capabilities, true to our commitment: Invested in Science, Invested in You!10:20 - 11:05 - Talk 1: Accelerating Synthetic Peptide Discovery, Quality Control, and Safety Testing with xCELLigence BioassayLeyna Zhao, Agilent TechnologiesSynthetic peptides and proteins are rapidly emerging as important therapeutic modalities, driving the need for robust approaches to evaluate biological activity, product quality, and safety throughout development. In this webinar, we will explore how Agilent’s label free xCELLigence Real Time Cell Analysis (RTCA) platforms can support synthetic peptide discovery, quality evaluation, and safety testing through functional, cell based bioassays. Selected case studies will highlight the use of real time, kinetic cellular readouts in peptide discovery and optimization workflows. Evaluation criteria for biological products will be reviewed in the context of ICH Q6B specifications, with emphasis on the role of bioassays in assessing biological activity. In addition, examples of toxicity testing using xCELLigence RTCA—including published vaccine related applications—will demonstrate how real time cell based assays can provide sensitive and reproducible QC results.11:10 - 11:50 - Talk 2: Unlocking Deeper Insights into Peptide Purity and Impurity Profiling with LC/MS for GLP-1 RA CharacterizationHolger Stalz, Agilent TechnologiesSynthetic Peptide therapeutics are reshaping the biopharma landscape, and GLP-1 receptor agonists are at the center of that momentum—raising the stakes for purity assessment and impurity profiling. Join this webinar to see how Agilent’s advanced LC/MS workflows help scientists tackle these challenges with greater confidence and efficiency. You’ll learn how the InfinityLab Pro iQ Plus LC/MSD enables reliable peptide purity confirmation, while the Agilent BioQTOF high-resolution LC/MS/MS system supports detailed sequence confirmation and impurity identification. We’ll also show how OpenLab CDS and MassHunter BioConfirm software simplify complex data interpretation, helping QC and R&amp;D teams move faster and make more confident decisions in peptide characterization.11:55 - 12:35 - Talk 3: Raman Spectroscopy in Peptide PharmaceuticalsJan Wuelken, Agilent TechnologiesRapid, non destructive raw material identification (RMID) through all types of packaging. Reliable identity verification of peptides, amino acids, protected building blocks, and excipients is a critical step in peptide manufacturing. The Agilent Vaya Raman Raw Material Identity Verification System is specifically designed to identify raw materials directly through non transparent and opaque containers, without opening the package. By leveraging Spatially Offset Raman Spectroscopy (SORS), Vaya minimizes interference from container walls, liners, and fluorescence. This enables fast and reliable identification through typical peptide pharma packaging, including plastic drums, paper and multi layer bags, FIBCs, and amber glass containers. The through container measurement capability eliminates the need for sampling, significantly reducing the risk of cross contamination and protecting operators from hazardous, highly potent, or sterile materials. At the same time, it streamlines workflows by reducing handling steps and operator exposure. Agilent Vaya supports high throughput, GMP compliant raw material testing, accelerates release to manufacturing, and helps ensure a secure, efficient supply of materials for peptide synthesis and downstream processing—from early development to commercial production.12:40 - 13:15 - Talk 4: Advanced Column Solutions to enhance your Peptide Analysis and Purification WorkflowsKatrien Sabbe, Agilent TechnologiesWhether you're optimizing existing methods or developing new ones, this session will equip you with the tools to streamline your peptide characterization and purification. LC analysis of peptides can be challenging due to their sensitivity to metal interactions within chromatographic systems, often leading to poor peak shape and reduced sensitivity. Agilent Altura HPLC columns with Ultra Inert technology overcome these challenges by minimizing metal-analyte interactions. We will illustrate how this innovation enhances resolution, reproducibility, and quantification in reversed phase and HILIC separations of therapeutic peptides such as GLP-1 receptor agonists. Furthermore we will explore preparative techniques and purification workflows, offering tips for achieving high purity and recovery in synthetic peptide purification.<blockquote>Presenter: Vitan Blagotinsek (EMEA Marketing Program Manager Bio/Pharma, Agilent Technologies)Vitan is the Agilent Marketing Manager for the Pharma and Biopharma markets across the EMEA region, covering a broad portfolio of all Agilent products with relevance to these markets. Prior to this role, he had started at Agilent as a Chromatography and Sample prep-focused Product Specialist targeting the Biopharma market in the DACH region. His scientific background is in Protein Biochemistry/Structural Biology. He graduated in Biochemistry from the University of Oxford in the UK and has a PhD from Marburg University in Germany (Department of Chemistry).</blockquote><blockquote>Presenter:&nbsp;Wolfgang Schiek (Director Business Development, BIOVECTRA, Agilent Technologies)Wolfgang is the BD Director Europe for Agilent Advanced Therapeutics, where he specializes in bespoke CDMO solutions and a chemist by profession. With a 25-year track record at industry leaders like Evonik, Cambrex, and Novasep in a variety of technical, commercial and strategic roles, he has helped numerous clients bridge the gap from drug development to successful market launch. For the past four years at AAT, he has focused on the cutting edge of biologics and peptides, serving as one of the primary forces behind the company’s GLP-1 programs.</blockquote><blockquote>Presenter: Leyna Zhao (Product Marketing Director, Agilent Technologies)Leyna is Product Marketing Director at Agilent Technologies, where she leads global strategy for cell analysis platforms, including xCELLigence Real-Time Cell Analysis (RTCA). With over 20 years of experience in molecular biology, immunology, and drug discovery, she bridges scientific innovation with market adoption. Her work focuses on advancing label-free, real-time technologies that support small molecule screening, immune cell function analysis, and predictive toxicology. She holds a PhD in Biochemistry and has been instrumental in aligning Agilent’s cell analysis solutions with emerging regulatory trends, such as non-animal testing methodologies.</blockquote><blockquote>Presenter: Jan Wuelfken (Product Specialist, Molecular Spectroscopy EMEA IDO, Agilent Technologies)Jan graduated from the University of Hamburg in 1997 with a thesis about NMR-based conformation analysis of an antimicrobial peptide and in 2001 with his PhD thesis about CD4-binding peptides as inhibitors for HIV infection. He joined Varian Inc. in 2001 as a sale representative for molecular spectroscopy and with the takeover of Varian by Agilent 2010 he became a product specialist for molecular spectroscopy in the Agilent International Distributor Organization (IDO). Today his responsibility is the full Agilent Molecular Spectroscopy Portfolio which is UV-Vis, UV-Vis/NIR, Fluorescence, FT-IR and Raman Spectroscopy.</blockquote><blockquote>Presenter:&nbsp;Holger Stalz (LCMS Product Specialist, Agilent Technologies )Holger has worked as a product specialist for LC/MS for Agilent in Austria and Switzerland since 2011. He leads a team of European BioPharma Specialists focusing on biopharmaceutical applications and has been coordinating the development of new analytical solutions and methods for protein therapeutics and oligonucleotide-based products.</blockquote><blockquote>Presenter:&nbsp;Katrien Sabbe (Biopharma Business Development Manager, Agilent Technologies)For more then 25 years Katrien has been working in the field of Chromatography Columns and Supplies, first at VWR International and later at Varian Analytical Instruments, which was acquired in 2011 by Agilent Technologies. Currently, she is the EMEA Biopharma Business Development Manager at Agilent Technologies Chemistries and Supplies Division.</blockquote>

BiteSizeBio: Innovations and Emerging Tools in Peptide Science

Innovations and Emerging Tools in Peptide Science

Explore advanced peptide technologies. Learn about GLP-1 API manufacturing, xCELLigence bioassays, through-container Raman RMID, and inert LC/MS workflows

Advanced Peptide Technologies and GLP-1 Analysis

This webinar will highlight the role of Kinetex® Amide in enabling robust and reliable HILIC LC–MS workflows for the analysis of highly polar compounds in complex matrices. Practical application examples will include the determination of residual lactose in dietary supplements to support lactose-free claims, along with method optimization under TFA and DFA mobile phase conditions. Attendees will gain hands-on insights into how Kinetex Amide delivers consistent retention, high selectivity, and excellent reproducibility, while preserving full LC–MS compatibility and supporting high laboratory productivity.<h5>Key Learning Points</h5><ul><li>Understand key considerations for HILIC LC–MS analysis of highly polar compounds.</li><li>Learn how to improve HILIC method robustness, reproducibility, and throughput in routine analysis.</li><li>Listen to a real case study of very polar compounds (amino acids, lactose, and organic acids).</li><li>Find how to apply robust workflows for lactose determination in lactose‑free products.</li><li>Review TFA and DFA determination in water.</li></ul><h5>Who Should Attend</h5><ul><li>Any LC and LC–MS users working in food, environmental and pharmaceutical laboratories who are involved in:</li><li>Analysis of highly polar compounds</li><li>Verification of lactose‑free products and simple sugar</li><li>Amino acid analysis</li><li>TFA and DFA Analysis</li><li>Routine QC and regulatory testing</li></ul><blockquote>Presenter: Luigi Margarucci (EMEA Seminar &amp; Application Lead, Phenomenex)&nbsp;Luigi, who holds a Ph.D. in Pharmaceutical Sciences, has over a decade of experience at Phenomenex. Since 2021, he has served as Technical Manager for Italy and EMEA Seminar &amp; Application Lead. Luigi gained extensive expertise in chromatography coupled with mass spectrometry while working as a researcher at the University of Salerno and collaborating with leading centers in Italy and Europe (including Utrecht University, NL). He is the author of 27 scientific publications and has delivered hundreds of seminars on analytical techniques such as HPLC, GC, and SPE.&nbsp;</blockquote>

Phenomenex: Enabling Robust HILIC LC–MS Workflows for Highly Polar Compound Analysis

Enabling Robust HILIC LC–MS Workflows for Highly Polar Compound Analysis

Optimize HILIC LC-MS workflows for highly polar compounds using Kinetex Amide. Improve method robustness for lactose, amino acids, and TFA/DFA analysis.

Robust HILIC LC-MS Workflows with Kinetex Amide

Lipid nanoparticle formulators often struggle to reproducibly separate components and resolve structurally similar analogues that can impact product safety and efficacy.Currently, no single reversed-phase column or standardized separation method has been established, resulting in significant time and financial investment in method development.In this webinar, we explore the properties and unique selectivity of our new lipid stationary phases, along with best practices and optimization strategies for LNP composition and critical impurity analysis critical for vaccines and emerging in vivo CAR-T. Learn how different detectors can enhance insight, how mobile phase additives can be used to tune selectivity, and how unique stationary phase properties enable robust, efficient method development from discovery through quality testing.<h5>Why you should attend</h5><ul><li>Understand how stationary phase properties affect LNP component separation.</li><li>Learn how to tune selectivity by adjusting mobile phases for improved impurities quantitation.</li><li>Identify optimal detection sources with UV, ELSD, CAD, and MS detection.</li></ul><h5>Who should attend</h5><ul><li>Biopharma analytical development scientists</li><li>Process development engineers</li><li>QC and CMC scientists</li><li>Lipid Synthesis chemists</li><li>Lab managers and directors in biologics and advanced therapies</li><li>Academic lab scientists including lipidomics</li></ul><blockquote>Speaker: Mateusz Imiolek, PhD (Principal Scientist, Waters Corporation)Mateusz joined Waters in 2022 where he has been studying challenges associated with characterizing gene therapeutics and ensuring that new Waters products are fit for this purpose.Before that, he completed his academic training in bioorganic chemistry, which allows him to apply detailed molecular insights to ensure the newly developed columns and assays are carefully designed for such analytes.</blockquote><blockquote>Speaker: Adam Kowalczyk (Research Scientist II – Analytical, Acuitas Therapeutics)Adam is a Research Scientist II at Acuitas Therapeutics, where he specializes in analytical method development for lipid nanoparticle (LNP)‑based therapeutics. His work focuses on characterizing complex lipid systems, optimizing impurity profiling strategies, and supporting process development through robust analytical data.With a strong background in chemistry and hands‑on experience in advanced LC and detection technologies, Adam brings deep technical insight into the challenges and requirements of modern LNP analysis.</blockquote>

Charge! Next-Generation LNP Assays with Waters Reversed Phase Charge Aerosol Detection

Improve LNP component separation and impurity analysis. Learn method development strategies using new lipid stationary phases and UV/ELSD/CAD/MS detection

Separation Strategies for Lipid Nanoparticles (LNP)

The rapid growth of genetic medicines - including oligonucleotides, plasmid DNA, mRNA, lipid nanoparticles (LNPs), and viral vectors - has introduced unprecedented analytical challenges. From shear‑induced degradation to poor resolution and reproducibility, traditional SEC approaches often struggle to deliver actionable insights for development, scale‑up, and QC.In this webinar, we explore next‑generation SEC columns designed specifically for mega molecules. Discover how wide‑pore SEC technology enables robust, high‑resolution size‑based characterization while preserving sample integrity. Through real‑world examples and best practices, our speaker will demonstrate how modern SEC workflows support faster decision‑making, improved inter‑lab reproducibility, and smoother regulatory pathways for advanced genetic medicine products.<h4>What You’ll Learn</h4><h5>Attendees will gain practical insights into:</h5><ul><li>Common SEC challenges in analyzing plasmids, mRNA, LNPs, and viral vectors</li><li>Strategies to minimize shear degradation and maintain biomolecule integrity during separation</li><li>Optimizing SEC methods for mega molecules using wide‑pore column technology</li><li>How to achieve reproducible, high‑resolution separations across labs and sites</li><li>Best practices for method development and extending SEC column lifetime</li><li>How faster SEC workflows can reduce development timelines and support regulatory submissions</li></ul><h4>Why attend?</h4>Traditional sizing techniques often fall short when applied to today’s complex, high‑molecular‑weight genetic medicines, leading to low resolution, high variability, and long run times.<h5>In this session, you’ll learn how modern wide‑pore SEC solutions:</h5><ul><li>Deliver robust, high‑throughput profiling for early discovery through late‑stage development</li><li>Support multi‑attribute characterization, including size distribution, aggregates, and integrity</li><li>Enable seamless integration with MALS detection for enhanced molecular weight and structural insight</li></ul><h4>Who should attend?</h4>This webinar is ideal for analytical scientists, process development teams, QC laboratories, and CROs working in cell and gene therapy, vaccines, and RNA‑based therapeutics.<blockquote>Presenter: Ali Tiss, Ph.D., MSc., Eng. (Chemistry Market Development Manager, Biopharma &amp; Cell and Gene Therapies, Waters Corporation)Ali joined Waters in 2021 and has since supported colleagues and users in the biomolecule separation field (proteins, peptides, Abs, conjugates, Cell &amp; Gene Therapy products). Ali completed his Ph.D. in biochemistry and structural biology at the Mediterranean University (CNRS, Marseille, France), where he contributed to the R&amp;D of the anti-obesity drug, Xenical®, developed by Roche Ltd. Then, he earned over two decades of research experience in biochemistry, liquid chromatography, mass spectrometry, and proteomics, focusing on detecting and characterizing biomarkers related to human diseases such as cancer, diabetes, and obesity. Ali is passionate about supporting customer business and innovative applications.</blockquote>

Advancing Size Exclusion Chromatography (SEC) for Characterization of Genetic Therapeutics

Advance SEC workflows for genetic medicines. Discover wide-pore column technology for high-resolution characterization of mRNA, LNPs, and viral vectors

Advancing SEC for Characterization of Genetic Medicines

<h4>How can you know that you catch all PFAS?</h4>Per- and polyfluoroalkyl substances (PFAS) comprise a group of highly persistent compounds that pose significant environmental concerns, particularly in water quality monitoring. Comprehensive characterization of PFAS contamination remains analytically challenging due to the chemical diversity of these substances and the limitations of individual methods.This webinar discusses complementary ion chromatography–based approaches for PFAS analysis in accordance with current standards. Combustion ion chromatography (CIC) enables the reliable determination of the total PFAS-related sum parameter AOF (adsorbable organically bound fluorine) and is standardized in DIN 38409-59, ISO 18127, and EPA 1621. &nbsp;This approach provides a robust overview of PFAS contamination levels.However, the AOF approach does not capture all PFAS. Ultra-short chain PFAS are highly hydrophilic and are less efficiently retained on activated carbon, and therefore are not detected by AOF analysis. One of the most prominent ultra-short chain PFAS is trifluoroacetic acid (TFA), a relevant degradation product that may account for a significant proportion of total PFAS in water samples. Ion chromatography coupled with mass spectrometry (IC-MS/MS) provides a sensitive and reliable approach for TFA determination in water matrices. In this webinar, the validated approach in accordance with DIN 38407-53 will be presented.&nbsp;<h4>Key learnings of this webinar:</h4><ul><li>Understand the regulatory background for PFAS analysis in water (DIN 38409‑59, ISO 18127, EPA 1621, DIN 38407‑53)</li><li>Learn how combustion ion chromatography (CIC) enables the reliable determination of total PFAS-related parameters such as AOF</li><li>Understand the relevance of trifluoroacetic acid (TFA) as a key ultra-short chain PFAS in water quality monitoring</li><li>Discover how IC‑MS/MS provides a sensitive and reliable approach for TFA determination according to DIN 38407‑53</li></ul><h4>Who should attend?</h4><ul><li>Water utility operators who need robust and dependable analytical techniques to guarantee the safety of drinking water</li><li>Scientists, researchers, and analytical method developers who need to stay up -to date on sophisticated/state-of-the-art methods for water analysis</li><li>Laboratory staff and managers who considering implementing reliable, cost- and time-efficient analysis of HAA in their lab</li></ul><blockquote>Speaker: Dr. Katinka Ruth (Senior Application Specialist IC, Metrohm International Headquarters)Dr. Ruth received her MSc in Chemistry at the Technical University Munich and a PhD in Environmental Sciences at the Swiss Federal Institute of Technology (ETH Zurich). She gained extensive knowledge in ion chromatography and hyphenation of ion chromatography to mass spectrometers during her 17 years of experience at Metrohm International Headquarters, where she holds a position as Senior Application Specialist.</blockquote><blockquote>Speaker:&nbsp;Theresa Steurer (Product Specialist IC, Metrohm International Headquarters)Theresa Steurer is a Product Specialist in the Ion Chromatography Competence Center at Metrohm International Headquarters in Herisau, Switzerland. She holds a degree in chemistry from the University of Vienna.With over eight years of experience in the ion chromatography applications laboratory, Theresa has developed extensive expertise in ion chromatography, with a particular focus on combustion ion chromatography.</blockquote>

Metrohm: PFAS Analysis with Ion Chromatography-Based Techniques

From Challenge to Confidence: PFAS Analysis with Ion Chromatography-Based Techniques

Advance your PFAS water monitoring. Combine Combustion IC for total AOF determination with IC-MS/MS for sensitive ultra-short chain TFA quantification

How to Ensure Complete PFAS Detection in Water Analysis

Robustness, reproducibility, and scalability are becoming increasingly important as proteomics workflows move closer to clinical and diagnostic applications.In this webinar, we will explore how the Evosep Eno supports the development of robust diagnostic assays through standardized, high-throughput LC–MS workflows. Join us to learn how reproducible performance, streamlined operation, and scalable proteomics methods can help accelerate the transition from discovery research to real-world applications.<h5>Robust Data from Evosep Eno coupled to Exploris 480 for the Development of Diagnostic Assays</h5>Models derived from machine learning approaches possess enormous diagnostic potential. At OXcan we create reliable machine learning models using training data sets generated from LC-MS data. A good model is accurate, reliable, and resistant to overfitting. In order to achieve this performance, the clinical and control data must have enough features and be sufficiently robust to allow the model to generate diagnostic features with a high degree of confidence.Accepting that there is a pressing need to create reliable proteomic data, to facilitate the training of machine learning models, we will discuss our workflow for generating robust data from digested plasma samples. The workflow leverages the performance capabilities of our Evosep Eno LC system coupled to a Thermo Exploris MS. This LC-MS platform gives us reproducible data, with the throughput required for the development of our machine learning derived diagnostic assays.<blockquote>Speaker: Giles Drinkwater (Researcher at OXcan Analytics)</blockquote>

Evosep: Assay Development for translational and research applications

Assay Development for translational and research applications

Advance translational proteomics for diagnostic assays. Explore high-throughput LC-MS workflows using Evosep Eno and Exploris 480 for machine learning models

High-Throughput LC-MS Workflows for Diagnostic Assays

Effective gene therapies require a thorough understanding of your delivery vehicle. Is it the right size? Does it contain an intact capsid, payload, and surface markers? Classic characterization methods don’t give structural insights, only look for a single component, and require purified samples to get actionable results. With the rise of in vivo CAR-T cell therapies, viral vectors have become increasingly complex to target the right cells and deliver cargo at the right time. Researchers need flexibility to adapt their characterization to the rapidly changing strategies for specified cell targeting and efficient gene delivery.Leprechaun is the only platform to deliver the complete biophysical ins and outs of individual lentivirus particles, with any combination of surface markers, at any stage from cell harvest to final stage, purified. Leprechaun combines interferometry and multi-channel fluorescence using a maximum of 25 µL of lentivirus, to characterize up to 16 samples in as little as a few hours. By assessing quality of lenti preps earlier in development, Leprechaun helps researchers obtain the most structurally intact lentivirus.In this webinar, we'll cover how Leprechaun delivers both sizing and structural data on lentivirus particles throughout purification and pinpoint steps for optimization. We’ll show how Leprechaun goes beyond ELISA and qPCR to provide additional insights by measuring multiple parameters on the same sample. Additionally, we’ll show some unique assays to measure breakout CAR expression to make sure your lenti is ready for in vivo CAR-T action. All these results showcase how Leprechaun is the go-to tool for complete biophysical characterization of lenti being developed for in vivo CAR-T cell therapies. &nbsp;<blockquote>Presenter:&nbsp;Brian Haldeman (Product Manager, Leprechaun, Unchained Labs)</blockquote>

Unchained Labs: Know the ins and outs of your lentivirus with Leprechaun 

Know the ins and outs of your lentivirus with Leprechaun

Characterize lentivirus particles for in vivo CAR-T cell therapies. Learn how Leprechaun delivers biophysical insights on sizing and surface markers

Advanced Lentivirus Characterization with Leprechaun

In a high-volume seized drug laboratory, identifying a robust and efficient case workflow is crucial for achieving high case throughput. It is imperative to balance multiple key factors to ensure an efficient workflow for successful presumptive testing of seized drug cases, including method speed (analytical time), analyst involvement, a comprehensive database, and ease of use. The upcoming webinar will address how the Acquity UPLC with the RDa detector has been employed to develop a comprehensive and efficient workflow for screening seized drug cases that incorporates all of the key factors.<blockquote>Presenter: Dr. Erin Shonsey (Director of Research and Development, Alabama Department of Forensic Sciences)Dr. Erin Shonsey is the Director of Research and Development for the Alabama Department of Forensic Sciences. As a board certified fellow of the American Board of Criminalistics in Drug Analysis, Dr. Shonsey received her Bachelor’s degree in Chemistry from Creighton University and her PhD in Pharmacology and Toxicology from the University of Alabama at Birmingham. With 15 years of experience, Dr. Shonsey provides technical oversight in the development and implementation of methodology for analysis of new and emerging drugs. Her keen ability to efficiently tackle this constant cat and mouse game has positioned Alabama’s only forensic crime laboratory to be able to identify the constant influx of drugs plaguing every community in Alabama.</blockquote>

Waters Corporation: Next-gen HRMS for toxicology and drug labs

Development and Implementation of an Efficient LC-TOF MS Screening Workflow in Seized Drug Analysis

The upcoming webinar will address how the Acquity UPLC with the RDa detector has been employed to develop a workflow for screening seized drug cases.

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