Mikroplasty a nanomateriály: Porozumění nově se objevujícím kontaminantům v environmentální analýze

Kyselina hyaluronová a&nbsp;sfingolipidy – dvě látky, které mají klíčový význam pro zdraví a&nbsp;funkci pokožky. Právě jejich propojení stálo v&nbsp;centru bádání Martina Juhaščika, absolventa FaF UK, který za svou disertační práci získal Mimořádnou cenu rektorky a&nbsp;také Zvláštní uznání poroty v&nbsp;soutěži Cena Sanofi za farmacii. Ocenění mu předal nositel Nobelovy ceny za chemii Jean-Marie Lehn.&nbsp;<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Forum_magazin_Univerzity_Karlovy_Michal_Novotny_Spolecna_cesta_k_patentu_Jak_UK_a_Contipro_tvori_inovace_2_4b1562263b.jpg" alt="Forum: magazín Univerzity Karlovy/Michal Novotný: Společná cesta k patentu: Jak UK a Contipro tvoří inovace " srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Forum_magazin_Univerzity_Karlovy_Michal_Novotny_Spolecna_cesta_k_patentu_Jak_UK_a_Contipro_tvori_inovace_2_4b1562263b.jpg 234w," sizes="100vw" width="1400" height="933">„Chtěli jsme vytvořit systém, který by dokázal efektivně dopravit účinné látky do pokožky, a&nbsp;přitom byl stabilní a&nbsp;šetrný. Kyselina hyaluronová je přirozeně hydratující a&nbsp;biokompatibilní (nevyvolává v&nbsp;těle nežádoucí reakce – pozn. red.), sfingolipidy zase posilují kožní bariéru. Spojením jejich vlastností vzniká kombinace s&nbsp;velkým aplikačním potenciálem,“ vysvětluje Martin Juhaščik.<h5>Začátky na kuchyňském robotu</h5>Na svém projektu pracoval v&nbsp;biotechnologické společnosti Contipro, s&nbsp;níž má Farmaceutická fakulta UK dlouhodobé vazby. Dnes zde působí jako vědecký pracovník. Firmu, která dnes patří mezi světovou špičku v&nbsp;oblasti výroby a&nbsp;zpracování kyseliny hyaluronové, založil v&nbsp;roce 1990 docent Vladimír Velebný, který se tehdy zabýval výzkumem pojivových tkání. Rozhodl se převést své poznatky z&nbsp;akademického prostředí do praxe a&nbsp;založil malé výrobní družstvo. Cesta za vysněnou výrobou kyseliny hyaluronové začala mícháním výživových doplňků pro sportovce na kuchyňském robotu určeném pro školní jídelny.Ze skromných začátků se firma rozrostla v&nbsp;moderní biotechnologické centrum se sídlem v&nbsp;Dolní Dobrouči, asi šedesát kilometrů od Hradce Králové ve směru na Orlické hory. Martin Juhaščik bydlí s&nbsp;manželkou kousek od ní. „Do práce většinou jezdím na kole. A&nbsp;nejsem sám. Celý region je protkán cyklostezkami, a&nbsp;když v&nbsp;zimě napadne sníh, pár kolegů přijíždí na běžkách. Je tu příjemná, přátelská atmosféra,“ popisuje.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Forum_magazin_Univerzity_Karlovy_Michal_Novotny_Spolecna_cesta_k_patentu_Jak_UK_a_Contipro_tvori_inovace_5_ba92fa8f8d.jpg" alt="Forum: magazín Univerzity Karlovy/Michal Novotný: Společná cesta k patentu: Jak UK a Contipro tvoří inovace " srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Forum_magazin_Univerzity_Karlovy_Michal_Novotny_Spolecna_cesta_k_patentu_Jak_UK_a_Contipro_tvori_inovace_5_ba92fa8f8d.jpg 234w," sizes="100vw" width="1200" height="800"><h5>Když technologie nestačí, vyvineme si vlastní</h5>Ve firmě Contipro dnes vzniká široké spektrum produktů – od kyseliny hyaluronové v&nbsp;různé kvalitě a&nbsp;čistotě až po inovativní aplikační formy jako jsou tenké filmy, mikrovlákna a&nbsp;nanovlákna. Hned na počátku ale musela společnost čelit výzvě, protože vhodné technologie, které by umožňovaly vyrobit kyselinu hyaluronovou podle jejích potřeb, nebyly dostupné. Z&nbsp;této situace se zrodila vize, která dnes patří k&nbsp;jejím největším přednostem. Všechny klíčové technologie si Contipro vyvíjí samo. Firma má vlastní divizi, která navrhuje a&nbsp;vyrábí specializované přístroje, včetně linky na výrobu nanovláken ve velkém měřítku. „Díky tomu dokážeme všechny procesy dělat přímo u&nbsp;nás. Od produkce kyseliny hyaluronové až po její finální úpravu,“ vysvětluje Martin Juhaščik.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Forum_magazin_Univerzity_Karlovy_Michal_Novotny_Spolecna_cesta_k_patentu_Jak_UK_a_Contipro_tvori_inovace_6_98b4b12f4c.jpg" alt="Forum: magazín Univerzity Karlovy/Michal Novotný: Společná cesta k patentu: Jak UK a Contipro tvoří inovace " srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Forum_magazin_Univerzity_Karlovy_Michal_Novotny_Spolecna_cesta_k_patentu_Jak_UK_a_Contipro_tvori_inovace_6_98b4b12f4c.jpg 235w," sizes="100vw" width="1200" height="799">Tuto tělu vlastní sloučeninu zajišťující hydrataci a&nbsp;pružnost tkání firma vyrábí biotechnologickou cestou, konkrétně fermentací. Jde o&nbsp;čistý a&nbsp;ekologický proces bez škodlivých odpadů. Výsledný produkt se pak dělí podle čistoty a&nbsp;použití – od kosmetické kvality pro pleťové krémy, přes potravinářskou pro doplňky stravy, až po farmaceutickou třeba pro oční kapky nebo injekční roztoky. Kromě vlastních produktů však firma dodává kyselinu hyaluronovou také farmaceutickým a&nbsp;kosmetickým společnostem po celém světě, a&nbsp;patří mezi pět největších světových producentů, kteří ji dokážou vyrábět v&nbsp;nejvyšší kvalitě. Firemní know-how chrání téměř sto třicet patentů. O&nbsp;jeden z&nbsp;nich se zasloužil díky svému doktorandskému výzkumu i&nbsp;Martin Juhaščik. Nyní se v&nbsp;Contipru zaměřuje na zkoumání vlivu samotné kyseliny hyaluronové na pokožku a&nbsp;sám také pomáhá vést nové studenty, kteří se vydávají podobnou cestou jako před pár lety on.<h5>Z&nbsp;mladých talentů vědci a&nbsp;vědkyně</h5>Důvodem, proč se firmě daří přitahovat špičkové výzkumníky do malé obce pod Orlickými horami, je podle Juhaščika promyšlený systém vzdělávání a&nbsp;podpory mladých talentů. Contipro působí v&nbsp;regionu už více než třicet let a&nbsp;během této doby zde vybudovalo vedle špičkových laboratoří i&nbsp;vlastní vzdělávací programy. Spolupracuje se středními školami a&nbsp;nabízí bakalářské i&nbsp;diplomové práce pro studenty vysokých škol. Mnoho zaměstnanců firmy pochází přímo z&nbsp;regionu, což vytváří silné komunitní prostředí. Mladí lidé tu začínají jako stážisté, postupně si zkoušejí různé pozice a&nbsp;často ve firmě zůstávají natrvalo. Contipro nabízí i&nbsp;takzvané Trainee programy pro absolventy, díky nimž mohou poznat různé části výzkumu a&nbsp;výroby a&nbsp;najít oblast, která jim nejvíc vyhovuje.„I já jsem původně přišel do Contipra v&nbsp;rámci disertační práce ve spolupráci s&nbsp;Farmaceutickou fakultou UK,“ vzpomíná Juhaščik. „Byla to skvělá příležitost propojit akademický výzkum s&nbsp;praxí – a&nbsp;vidět, jak se vědecký nápad může proměnit v&nbsp;hmatatelný výsledek,“ shrnuje vědec.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Forum_magazin_Univerzity_Karlovy_Michal_Novotny_Spolecna_cesta_k_patentu_Jak_UK_a_Contipro_tvori_inovace_4_e34a203649.jpg" alt="Forum: magazín Univerzity Karlovy/Michal Novotný: Společná cesta k patentu: Jak UK a Contipro tvoří inovace " srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Forum_magazin_Univerzity_Karlovy_Michal_Novotny_Spolecna_cesta_k_patentu_Jak_UK_a_Contipro_tvori_inovace_4_e34a203649.jpg 234w," sizes="100vw" width="1200" height="800"><blockquote><h5>PharmDr. Martin Juhaščik, Ph.D.</h5>Absolvent Farmaceutické fakulty Univerzity Karlovy, kde vystudoval farmaceutickou technologii. Ve své disertační práci se zaměřil na konjugáty kyseliny hyaluronové se sfingolipidy určené pro topické použití, za kterou získal Mimořádnou cenu rektorky UK a Zvláštní uznání poroty v soutěži Cena Sanofi za farmacii. Dnes působí jako vědecký pracovník ve společnosti Contipro v Dolní Dobrouči, kde se věnuje vývoji biomateriálů a kosmetických surovin na bázi kyseliny hyaluronové. Je také spoluautorem českého patentu v této oblasti a podílí se na vedení mladých výzkumníků, kteří ve firmě získávají své první vědecké zkušenosti.</blockquote>

 Společná cesta k patentu: Jak UK a Contipro tvoří inovace 

<div><div>Náš imunitní systém je neuvěřitelně silný. Dokáže totiž mimo jiné sám rozpoznat a zničit rakovinné buňky. Nádorové buňky jsou ale na tento útok připravené: vytvářejí si vlastní „neviditelné štíty“, které je před imunitním systémem chrání.</div></div><div>Průlom v léčbě rakoviny přinesly látky, které dokážou imunitní buňky znovu aktivovat. Ty pak mohou proniknout neviditelným štítem nádoru a znovu proti němu zasáhnout. Bohužel je ale tato léčba účinná zatím jen u 20–50 % pacientů. Vědci a vědkyně proto hledají nové způsoby, jak imunitní buňky znovu aktivovat. Důležitou roli v tomto procesu hraje malá a dobře známá molekula zvaná adenosin.Když jsou nádorové buňky ve stresu nebo odumírají, uvolňují do svého okolí molekuly adenosintrifosfátu (ATP). Tím dávají imunitnímu systému najevo, že něco není v pořádku. Mikroprostředí nádoru však zároveň skrývá právě onen neviditelný štít, který uvolněné ATP rychle rozkládá na adenosin, a varovný signál tak zaniká. K této přeměně slouží dva enzymy označované CD39 a CD73.Uvolněný adenosin pak působí jako uklidňující chemický signál: váže se na imunitní buňky, zpomaluje je a snižuje jejich schopnost rozpoznávat a ničit rakovinné buňky. Pokud by se podařilo zablokovat enzym CD73, bylo by možné neviditelný štít nádoru vyřadit z provozu a otevřít tak novou cestu k léčbě rakoviny.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/UOCHB_Nove_latky_mohou_podporit_imunitni_system_v_boji_s_rakovinou_88c5e82cd5.jpeg" alt="ÚOCHB: Nové látky mohou podpořit imunitní systém v boji s rakovinou" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_UOCHB_Nove_latky_mohou_podporit_imunitni_system_v_boji_s_rakovinou_88c5e82cd5.jpeg 245w," sizes="100vw" width="661" height="363">Mezioborové týmy z ÚOCHB vedené Janem Řezáčem, Janem Konvalinkou a Michalem Hockem využily novou metodu vysokokapacitního screeningu a otestovaly více než 5000 sloučenin. Díky tomu objevily dva deriváty ribonukleosidů, které se ukázaly jako slibné inhibitory enzymu CD73.Vědci pak jejich účinnost dál zvýšili úpravami základní chemické struktury, zejména přidáním prostorově objemných (hetero)arylových skupin. Následná optimalizace navíc zlepšila i jejich farmakokinetické vlastnosti, tedy jak se léčivá látka v organismu vstřebává, distribuuje, metabolizuje a vylučuje. Výsledkem jsou sloučeniny, které vydrží v organismu dostatečně dlouhou dobu, zároveň mají vysokou rozpustnost a také selektivitu vůči příbuzným enzymům, například právě CD39.Buněčné experimenty ukázaly, že tyto látky snižují produkci adenosinu v rakovinných buňkách, obnovují aktivaci imunitních T buněk a zároveň nepůsobí toxicky na lidské tkáňové buňky. Nejúčinnější ze zkoumaných látek dosáhla inhibiční konstanty v řádu jednotek pikomolů. Jedná se o hodnotu, která vyjadřuje, jak silně se inhibitor váže na cílový enzym nebo receptor a jak účinně ho blokuje. Čím nižší je tato hodnota, tím silněji a účinněji inhibitor na svůj cíl působí.Publikované výsledky představují důležitý výchozí bod pro navazující výzkum a další rozvoj této slibné třídy látek. Budoucí studie in vivo i kombinované experimenty nyní pomohou podrobněji prověřit účinnost těchto látek a ukázat, do jaké míry by mohly najít uplatnění v léčbě nádorových onemocnění.<blockquote><h4>Původní článek</h4><h4><a target="_blank" rel="noopener noreferrer" href="https://pubs.acs.org/doi/10.1021/acsptsci.5c00707">Silné kompetitivní inhibitory ekto-5′-nukleotidázy (CD73) na bázi 6-(het)aryl-7-deazapurinových ribonukleosidových 5′-O-bisfosfonátů</a></h4>Ugnė Šinkevičiu̅tė, Magdalena Šímová, Radek Staník, Lenka Poštová Slavětínská, Kristýna Blažková, Pavel Šácha, Martin Lepšík, Jan Řezáč, Jan Konvalinka, Tereza Ormsby, Michal Tichý, Michal HocekACS Pharmacol. Transl. Sci. 2026, 9, 1, 191–213<a target="_blank" rel="noopener noreferrer" href="https://pubs.acs.org/doi/10.1021/acsptsci.5c00707">https://pubs.acs.org/doi/10.1021/acsptsci.5c00707</a><h6>licencováno pod <a target="_blank" rel="noopener noreferrer" href="https://creativecommons.org/licenses/by/4.0/">CC-BY 4.0</a></h6></blockquote><h4>Abstrakt</h4>CD73 produkuje v mikroprostředí nádoru imunosupresivní adenosin a představuje slibný cíl pro imunoterapii nádorových onemocnění. Navrhli jsme a systematicky studovali rozmanité 2-substituované 7-deazapurinové ribonukleosidové 5′-O-bisfosfonáty nesoucí různé (het)arylové skupiny v poloze 6 a prokázali jsme jejich vysoce účinnou a selektivní inhibiční aktivitu vůči CD73. Nejaktivnější sloučeniny (s Ki v řádu jednotek pikomolů) obsahovaly v poloze 6 bicyklické (het)arylové skupiny v kombinaci s chlorem v poloze 2. Další optimalizace farmakokinetických vlastností vedla k identifikaci inhibitorů s nízkou clearance, dlouhým poločasem, vysokou rozpustností a vynikající selektivitou vůči CD39 a NTPDase3. Tyto sloučeniny účinně potlačovaly tvorbu adenosinu v buňkách MDA-MB-231, obnovovaly aktivaci CD8+ T lymfocytů a byly netoxické vůči lidským fibroblastům. Celkově se jejich profil příznivě srovnává s AB680, inhibitorem CD73, který je v současnosti ve fázi I/II klinických studií.</div>

Nové látky mohou podpořit imunitní systém v boji s rakovinou

Životní prostředí

Vědecký článek

Popularizace

Věda a výzkum

Článek

ÚOCHB AV ČR je přední mezinárodně uznávaná vědecká instituce, jejímž hlavním posláním je základní výzkum v oblasti chemické biologie a medicinální chemie, organické a materiálové chemie, chemie přírodních látek, biochemie a molekulární biologie, fyzikální chemie, teoretické chemie a analytické chemie.

Ústav organické chemie a biochemie AV ČR

Společnost Organomation, založená v roce 1959, navrhuje a vyrábí vysoce kvalitní dusíkové koncentrátory a extrakční systémy. Jejich laboratorní přístroje, známé svou inovativností a odolností, se používají po celém světě pro efektivní přípravu vzorků a jsou doprovázeny silnou zákaznickou podporou.

Organomation

Reportáže, rozhovory, zprávy o vědeckých projektech a studentských akcích ... Jsme online informační bránou Univerzity Karlovy.

Forum: magazín Univerzity Karlovy

Separation Science

Agilent Technologies

C&EN

Shimadzu Corporation

Waters Corporation

Controlling peptide-related impurities is essential to meet regulatory requirements and ensure product quality. The presence of impurities in drug substances and finished products can pose significant immunogenicity risks to patients, potentially leading to drug recalls or warning letters from regulatory bodies.In this webinar, Dr Manoj Metta from the United States Pharmacopeia (USP) will discuss challenges, regulatory expectations and USP solutions to help ensure the quality of peptide therapeutics. Dr Caitlin Hanna from Waters will describe a reverse-phase LC-UV method development case studies for the impurity analysis of fatty-acid modified GLP-1 receptor agonists.Key learning objectives:<ul><li>Understand the key analytical challenges and regulatory expectations for peptide quality assessment</li><li>Learn about USP products and solutions for peptide impurity analysis</li><li>Explore column screening and method development considerations for the analysis of fatty-acid modified GLP-1 receptor agonists</li></ul><blockquote>Presenter: Manoj Kumar Metta, Ph.D. (Principal Scientist, Global Biologics, United States Pharmacopeia (USP))Dr. Manoj Metta is a seasoned Biological Scientist with 21 years of expertise in biologics quality establishment and regulatory sciences. Currently, he serves as Principal Scientist in Global Biologics at the U.S. Pharmacopeia (USP), where he specializes in the quality assessment of Monoclonals, Peptides, and Oligonucleotide drug products. Over his 14+ years at US Pharmacopeia, Dr. Manoj has made significant contributions to compendial sciences, including the development of monographs, reference standards, and general chapters for biologics.<div>He also leads research initiatives focused on developing innovative analytical methods, in vitro characterization techniques, and drug release testing methodologies. He is a USP-approved instructor for Biologics education courses and an international speaker, having delivered talks globally. Additionally, he serves as a quality auditor for Quality Management System (QMS) evaluations in supplier qualification.Dr. Manoj received his Ph.D. in Biotechnology from the Gandhi Institute of Technology and Management.</div>Presenter: Caitlin Hanna, Ph.D. (Senior Scientist, Waters Corporation)<div>Caitlin Hanna is an analytical chemist experienced in sample preparation and LC-UV/MS for biopharmaceutical CQA analysis. She received her PhD in Chemistry from the University of California, Irvine in 2019 and joined Waters Corporation in 2022. Currently, she serves as Senior Scientist in the Bioseparations portfolio. Her work focuses on the development and application of sample prep and chromatography tools for assessing the quality of mAb and peptide biotherapeutics.</div>Moderator: Isabelle Vu Trieu (Pharmaceutical Market Development Manager, Americas, Waters Corporation)Isabelle is a business development professional dedicated to delivering benefits to analytical scientists in the life sciences industry. With over 20 years of experience in providing chromatography and mass spectrometry solutions, Isabelle is particularly interested in helping pharmaceutical scientists achieve the data quality and integrity needed to drive decisions for drug quality, safety and efficacy. Isabelle joined Waters in 2009 and currently manages the development of the pharmaceutical market in the Americas. She holds Masters’ degrees in Chemistry from Columbia University and the University Claude Bernard in Lyon, France as well as a Chemical Engineering degree from Ecole Supérieure de Chimie Physique Electronique in Lyon, France.</blockquote>

Waters Corporation: Solving Problems That Matter - a Waters webinar series featuring USP speakers

Peptide Impurities and GLP-1

We will discuss challenges, regulatory expectations and USP solutions to ensure the quality of peptide therapeutics and describe a RP LC-UV method development.

<h4>PFAS in Focus</h4>Welcome to the PFAS in Focus, a comprehensive and exclusive 10-parts webinar series sponsored by Shimadzu, covering the basics and beyond about the analysis of Per- and Polyfluoroalkyl Substances (PFAS) in the environment. In these five webinars, our experts will demonstrate the suitability of various analytical techniques, such as LCMS, GCMS, CIC, and QTOF, for PFAS testing.Join our experts, live or on-demand after the original air date, to demystify the challenges of PFAS analysis and gain the insights you need to:<ul><li>Manage PFAS contamination in your laboratory.</li><li>Master standardized methods for PFAS testing.</li><li>Discover new analytical workflows to maximize the performance of your instruments (LC-MS/MS, GCMS, CIC, QTOF) for PFAS analysis.</li></ul><h5>Who should attend:</h5><ul><li>Environmental industry professionals and academics currently working on PFAS analysis or looking to establish the application in their labs.</li><li>Representatives from drinking and wastewater utilities.</li><li>LC–MS users from any field interested in expanding their applications to include PFAS testing.</li></ul><h4>Part 05: Ask Us Anything About the Analysis of PFAS</h4>As closing event of the PFAS In Focus webinar series, we will host a live panel discussion. Top experts in the field will provide their perspectives and answer your questions about PFAS testing in diverse environmental samples (water, soil, tissue…).&nbsp;<a target="_blank" rel="noopener noreferrer" href="https://share.hsforms.com/1LXbA9M17S1WNBHvxGUCB3w4t3j7">Submit your questions in advance here by April 3rd, 2025. </a>Or be ready to submit them during the live webinar on April 17th, 2025. Do not miss to get your questions answered and become the PFAS expert in your lab.We will host a Q&amp;A session after the presentation to address any questions or comments.<blockquote>Presenter: Ruth Marfil-Vega, PhD (Sr Market Manager – Environmental, Shimadzu Scientific Instruments)Dr. Ruth Marfil-Vega has 20 years of expertise in environmental chemistry and engineering in the US and Europe. She has worked with the EPA and the utilities industry to design and execute comprehensive solutions for addressing new environmental and water quality issues, including PFAS, regulated and unregulated DBPs, and other emerging contaminants. Since Ruth joined Shimadzu five years ago, she has continued to work with environmental stakeholders to ensure that analytical instrumentation and workflows support their success. She earned a BSc in Chemistry from the University of Valladolid (Spain) and a PhD in Environmental Science and Engineering from the University of Cincinnati.Panelists: Top experts in the field will provide their perspectives and answer your questions about PFAS testing. Pannelists to be announced.</blockquote>

Ask Us Anything About the Analysis of PFAS

As closing event of the PFAS In Focus webinar series, we will host a live panel discussion. 

Nitrosamines have been the compounds of interest for the pharmaceutical industry in recent years due to the mutagenic nature of these impurities. This all started with one nitrosamine impurity N-Nitroso dimethylamine (NDMA) and eventually the list expanded to many nitrosamines in various drug substances and drug products.&nbsp;More recently nitroso-drug substance-related impurities (NDSRI) became the major concern for the industry. As per regulations, any possibility for the formation of Nitroso impurity in the synthetic route or the manufacturing process of the drug substance must be evaluated, and steps must be taken to identify, quantify and minimize/eliminate such impurities. So, the presence of robust methods for the detection and quantitation of such impurities is the need of analytical laboratories. By attending this session, you will understand that the discussion will focus on helping companies getting started in their journey with nitrosamines. It will cover the steps companies need to take to ensure they have a sufficient nitrosamines risk assessment.<blockquote>Presenter: Danita Broyles (Harmony Biosciences)is a native of Clarksdale, MS. She received her B.S. in Chemistry from Rust College and a dual degree M.S. in Biomedical Engineering from the University of Memphis, and the University of TN-Memphis Health Science Center. Danita has an extensive career in the pharmaceutical industry where she tested and released raw materials, performed analytical method validations/transfers, and led compendial compliance and advocacy initiatives throughout her career. Danita is currently the Director of Quality Assurance – CAMS at Harmony Biosciences. She leads a group that specialized in all things Compendial, Analytical, Microbiology, Stability, and Special Project related at Harmony Biosciences. Danita is Co-Chairperson of the Mid-West Compendial Discussion Group, Treasurer of the New Jersey Pharmaceutical Quality Control Association, and she Co-Chairs the USP Stakeholder Engagement Planning Committee. Danita also serves on the USP’s Nominating Committee for the Council of Experts for the 2025-2030 cycle. Danita is a well sought after speaker who has presented a numerous conferences and events throughout her career.Presenter: Chander Mani (Field Technical Specialist-LC Columns, Agilent Technologies, Inc.)Mr. Chander Mani holds a Master’s degree in Chemistry and began his career at Panacea Biotec in the Analytical &amp; Bioanalytical department of new drug discovery research. There, he specialized in method development for analytical and bioanalytical analysis, as well as ADME/DMPK-related studies. He later joined Bureau Veritas, where he developed multiple LC-MS-based methods for analyzing textiles and environmental analytes of interest. For over 12 years at Agilent, Chander has been actively involved in providing LC and LC-MS application support across pharmaceuticals, food safety, and environmental applications in various roles. Recently, he has focused extensively on Nitrosamine analysis in pharmaceuticals, utilizing both LCTQ and LCQTOF platforms, and has published multiple application notes. In his current role as a Technical Specialist for LC and GPC columns, he collaborates closely with customers across the US and Canada.</blockquote>

Agilent Technologies: Navigation Pharma Regulations: Insight and Innovations

Navigating Nitrosamines – Back to Basics

This session will help companies begin their journey with nitrosamines, covering key steps to ensure a sufficient nitrosamines risk assessment.

<div><div>The detection and quantification of drugs in hair presents many challenges, especially when analyzing multiple classes of drugs simultaneously. The objective of this work was to develop, optimize and validate a method for the extraction and quantification of a comprehensive panel of drugs in hair to satisfy the confirmation cut-off values recommended by the society of Hair Testing (SoHT).Sample preparation conditions were adjusted for optimal extraction of all compounds, including hair pretreatment, the initial incubation conditions and solid phase extraction. The finalized method included an initial incubation to extract analytes from hair samples, followed by mixed-mode SPE clean-up and UPLC-MS/MS analysis using the Waters TQ Absolute. The drug panel included, opiates, amine stimulants, benzodiazepines, synthetic opiates and other common drugs of abuse.Efficient and clean sample extraction enabled a robust method that was validated for linearity, sensitivity, accuracy and precision for 58 analytes. We were able to achieve functional sensitivities down to 0.01 ng/mg for most analytes and as low as 0.001 ng/mg for fentanyl allowing all analytes to meet their SoHT recommended cut-offs. All analytes in external positive control samples were positively identified and &gt;80% had concentrations that fell within the manufacturer’s acceptance range.We have developed a robust method for quantitative analysis of a comprehensive panel of drugs in hair that meets SoHT’s cutoff criteria. This enabled the quantitative validation of a method for 58 compounds that can be applied to other related compounds as well.<h4>Key learning objectives:</h4><ul><li>Understand the challenges with detecting and quantifying multiple classes of drugs in hair samples</li><li>Learn how to develop a comprehensive multi-panel drug method in hair samples that meets SoHT's cutoff criteria</li><li>Learn detailed sample preparation techniques, including hair pretreatment and solid phase extraction</li></ul>For Forensic Toxicology Use only.<blockquote>Presenter: Jonathan P DanaceauDr. Jonathan Danaceau, Ph.D. is a Principal Scientist with Waters. He received his B.S. in Biology from Allegheny College and a Ph.D. in Neuroscience from the University of Utah (Salt Lake City, UT). Jon came to Waters in 2011 after spending several years in the forensic toxicology and sports doping fields. Since joining Waters, he has focused on sample preparation and LC/MS/MS solutions for forensic, clinical research, and other bioanalytical applications. He is an expert in sample preparation and bioanalytical method development and has published several papers in these fields. Jon is currently with the Waters Clinical Business Unit.</blockquote></div></div>

Waters Corporation: Extraction and Analysis of a Comprehensive Quantitative Drug Panel in Hair Samples by UPLC-MS/MS for Forensic Toxicology

Extraction and Analysis of a Comprehensive Quantitative Drug Panel in Hair Samples by UPLC-MS/MS for Forensic Toxicology

Understand the challenges with detecting and quantifying multiple classes of drugs in hair samples

UPLC-MS/MS Analysis of Drugs in Hair Samples

<div><div>The random appearance of unknown peaks (ghost peaks), contaminant peaks, loss of sensitivity or lack of reproducibility are not uncommon in chromatography. Determining the root cause of these issues can be time-consuming and difficult to troubleshoot. In many cases, the root cause is determined to be the sample vials.&nbsp;In this webinar we’ll delve into the critical role of chemically tested sample vials, ensuring accurate and reliable analytical outcomes. Discover how seemingly minor details—such as vial septum material, dimensions, and the glass surface can significantly impact your results. Our experts will guide you through real-world cases where choosing the right vial made all the difference.<h4>Here’s what you’ll learn:</h4><ul><li>Understand the vial characteristics that directly influence your analytical data.&nbsp;</li><li>Explore Waters’ range of sample vials designed to address common challenges.&nbsp;</li><li>Learn practical tips for diagnosing and preventing vial-related issues in chromatography.&nbsp;</li></ul><blockquote>Presenter: Markus Wanninger (Principal Product Manager, Waters Corporation)Markus is the principal product manager of sample vials and plates. He has a degree in chemical engineering and long-standing experience in the pharmaceutical industry. Markus has a keen understanding of the needs of analytical HPLC laboratories, and the controls required to have certainty in results and staying in compliance. The drive to control and optimize processes enabled the Markus and the vials team to drive continuous improvement of product lines to meet the demands of todays’ laboratories. Outside his professional life Markus is a passionate photographer and an inspiring chef and pitmaster.Presenter: Nikunj Tanna (Principal Scientist, Waters Corporation)Nikunj Tanna is a Principal Scientist at Waters Corporation who is passionate about meeting people, making connections, and learning from every conversation. His role at Waters focuses on complete workflow solutions for quantitation of small and large molecules. These end-to-end workflows include automation, novel sample preparation and chromatographic separation approaches, followed by detection using TQ and/or HRMS platforms. In his current role, he has particular emphasis on sample preparation and automation for bioanalysis, ADME and DMPK applications. In previously roles, he lead a clinical diagnostics team at Berg LLC developing bioanalytical methods for drug candidates. He graduated with a BS in Biotechnology and MS in Bioanalytical Sciences from the University of Mumbai, and MS in Pharmaceutical Sciences from Northeastern University.</blockquote></div></div>

Waters Corporation: Are your sample vials causing problems in your HPLC analysis?

Are your sample vials causing problems in your HPLC analysis?

Discover how seemingly minor details—such as vial septum material, dimensions, and the glass surface can significantly impact your results. 

Are your sample vials causing problems in your HPLC analysis

Maintaining water purity in ultra-pure water (UPW) systems, pressurized water reactors (PWR), and steam generation is a constant challenge. Even trace contaminants can lead to corrosion and costly downtime. Detecting these impurities quickly and at ultra-low levels is critical to maintaining performance and preventing operational disruptions. Ion chromatography (IC) provides the precision needed for this level of detection, delivering high-sensitivity trace analysis to identify contaminants and keep water chemistry within strict operational limits.What if you could move from periodic lab testing to continuous monitoring? This shift enhances water quality control, minimizes manual intervention, and improves overall process performance. Semiconductors, nuclear power plants, and refineries rely on online trace analysis to prevent failures and optimize operations. Join us as we explore how integrating trace analysis from benchtop to process monitoring maximizes system integrity. Learn best practices for implementing online ion chromatography and discover how real-time data can improve decision-making and operational efficiency.<div>Key learnings objectives:<ul><li>Learn how ion chromatography enables precise trace analysis for monitoring water quality in UPW, PWR, and steam generation systems.</li><li>Understand how techniques from benchtop systems can be applied to process analytical technology for real-time water quality control.</li><li>Gain insights into integrating trace analysis into both lab and process environments for reliable water quality management.</li></ul>Who Should Attend:<ul><li>Process Engineers looking to integrate advanced trace analysis techniques into operational processes for real-time monitoring</li><li>Quality Control Managers responsible for maintaining product standards and minimizing defects</li><li>Production Managers seeking to enhance efficiency and reduce production costs</li><li>Plant Managers overseeing the overall production process and quality control</li><li>Sustainability and Operations Managers tasked with implementing sustainability practices within their organizations and overseeing the day-to-day operations</li><li>R&amp;D Scientists developing new methods and technologies for improving water quality monitoring and trace analysis in industrial settings</li></ul><blockquote>Presenter: Andrew Schmidt (Nuclear Chemist, Florida Power &amp; Light)Presenter:&nbsp;Dariana Martinez (Product Applications Specialist, Process Wet Chemistry, Metrohm USA)Presenter:&nbsp;Shibu Paul, Ph.D. (Product Specialist, Ion Chromatography, Metrohm USA)</blockquote></div>

Metrohm: Bridging Lab and Process Monitoring for Real-Time Water Quality Insights

Bridging Lab and Process Monitoring for Real-Time Water Quality Insights

Learn how ion chromatography enables precise trace analysis for monitoring water quality in UPW, PWR, and steam generation systems.

Real-Time Water Insights: Lab & Process Connected

Discover the latest innovations in biopharma with a focus on monoclonal antibody (mAb) characterization. This session highlights how Shimadzu’s advanced LCMS-9050 Q-TOF and Protein Metrics software deliver precise analysis of complex biomolecules. Learn how high-resolution mass spectrometry (HRMS) paired with optimized data processing can effectively deliver identification and quantification of Critical Quality Attributes (CQAs) including intact mass and post-translational modifications (PTMs).Gain actionable insights into our end-to-end workflow solution—from best practices in sample preparation to selecting the right columns and consumables—designed to optimize analytical accuracy and reproducibility. Whether in early discovery or late-stage processes, this session provides essential strategies to meet the evolving demands of mAb analysis to advance your biopharmaceutical analysis.<h5>Learning Objectives:</h5><ul><li>Understand the principles and applications of monoclonal antibody (mAb) characterization using Shimadzu’s Q-TOF LCMS-9050</li><li>Explore how Protein Metrics software streamlines data processing in biopharmaceutical analysis</li><li>Gain insights into an end-to-end workflow, covering sample preparation, column selection, and consumables to ensure reproducibility and high-quality results across all development stages</li></ul><blockquote>Presenter: Sheldon Gao (Customer Success Scientist, Protein Metrics)Sheldon Gao, who holds a master’s degree from China Pharmaceutical University specializing in pharmaceutical analysis and protein racemization, has been a Customer Success Scientist at Protein Metrics since 2022. In this role, he provides technical expertise and support to customers across China and the APAC region. Prior to this, Sheldon worked at Merck, where he focused on developing LC-MS/MS methods and protein characterization. Today, he will introduce Byos, highlighting its core features and showcasing its ability to streamline protein characterization data processing efficiently.Presenter:&nbsp;Shannie Tay (Senior Application Specialist (LCMS) Shimadzu (Asia Pacific) Pte Ltd)Shannie Tay is a Senior Application Specialist at Shimadzu (Asia Pacific) Pte Ltd, bringing a wealth of experience in LCMS platforms and a strong background in the biopharmaceutical industry. Her expertise in mAb characterization, quality control, and method development has been honed through positions at leading organizations such as Nestlé NQAC, CellVec Pte Ltd, and Tychan Pte Ltd. At Nestlé R&amp;D, she served as a subject master coach for LCMS triple quad systems, conducting ISO 17025-compliant QC tests. Later, at CellVec and Tychan, Shannie led the QC team, establishing workflows and achieving GMP certification. She authored application notes on mAb characterization, developing an end-to-end workflow with the LCMS-9050 Q-TOF, encompassing sample preparation to data analysis. Widely respected for her ability to create effective analytical workflows and deliver advanced training, Shannie has earned a solid industry reputation for her contributions to QC processes and solutions to complex issues. She will offer valuable insights in today’s discussion.Presenter:&nbsp;Derrick Tan (Senior Application Chemist (Consumables) Shimadzu (Asia Pacific) Pte Ltd)Dr Derrick obtained his PhD in Chemistry from Nanyang Technological University, Singapore.With over 7 years of extensive research experience, Dr Derrick has specialized in various areas, including small molecules, nucleic acids, peptides, and protein synthesis, as well as separation and purification techniques. He joined Shimadzu (Asia Pacific) Pte Ltd in 2021 as an Application Chemist (Consumables).In this role, he is responsible for providing technical support and application expertise for consumables in chromatography and spectroscopy. Portfolio under his care includes a wide range of products, such as LC and GC columns, UV/Vis cuvettes, sample preparation products, sample vials, and other accessories.</blockquote>

Shimadzu: Advanced mAb Characterization With LCMS-9050 QTOF And Byos

Advanced mAb Characterization With LCMS-9050 QTOF And Byos

We will introduce an innovative system with dual analysis capability for both PFAS and cyanotoxins, adhering to EPA Methods 

Reimagine your laboratory experience with Shimadzu’s Living Laboratory, where digital transformation (DX) becomes a reality. &nbsp;As the first AI-assisted automation laboratory, the Living Laboratory seamlessly integrates Shimadzu’s hardware and software into a single ecosystem, delivering a truly next-level laboratory experience. Whether it’s walkaway automation or the ability to work anywhere, the Living Laboratory enables you to work smarter, not harder, while staying at the forefront of innovation. &nbsp;Join us today and experience seamless connectivity, AI-powered capabilities, and paperless workflows—all designed to simplify and optimize various aspects of your lab operations. &nbsp;Discover The Benefits Of Shimadzu’s Living Laboratory<ul><li>AI-Driven Automation: Boost efficiency with eco-friendly, intelligent systems powered by Analytical IntelligenceTM</li><li>Flexibility to Work From Anywhere: Complete control of your lab processes, wherever you are</li><li>Enhanced Productivity: Gain clear insights with advanced software intuitive to all users regardless of skill levels</li></ul>Begin your transformation today. Discover Shimadzu’s Living Laboratory and unleash your full DX capabilities.

Shimadzu: Living Laboratory Unleashed: Your Gateway To Complete DX Capabilities

Living Laboratory Unleashed: Your Gateway To Complete DX Capabilities

Join us today and experience seamless connectivity, AI-powered capabilities, and paperless workflows

Gateway To Complete DX Capabilities

Drug discovery and synthesis are crucial steps in the drug development process and having the proper tools to quickly create and purify drug candidates to inform both upstream and downstream decisions are paramount. However, the field of preparative purification has expanded into many different methodologies depending on your drug modality, that it can be challenging to make sense of the different prep methods. Shimadzu has a wide array of instrumentation that can be tailored to anyone’s preparative purification needs.Attend this webinar on Wednesday, April 16th at 2:00 pm to learn more about our solutions for the preparative purification in the drug discovery space.We will host a Q&amp;A session after the presentation to address any questions or comments.<blockquote>Presenter: Kevin Wons (Market Manager - Pharma/BioPharma, Shimadzu Scientific Instruments)Kevin joined Shimadzu in early 2024 as Market Manager for Pharma/BioPharma. Prior to joining Shimadzu, he spent 6 years at AstraZeneca in the Analytical Sciences Department for product and process characterization for biologics in the AstraZeneca pipeline. Kevin has applications experience with HPLC and LC-MS to do Tryptic Peptide Mapping, Intact Mass Analysis, Subunit Mass Analysis, and Oligosaccharide Profiling. For his last 3 years, he acted as the Glycan Subject Matter Expert (SME) while at AstraZeneca. His work experience also includes Maryland Psychiatric Research Center, where he prepared animal tissue samples such as Brain, Liver, Blood, and Placenta to measure kynurenine pathway metabolites on GC/MS and HPLC. He has a Master’s degree in Professional Studies (MPS) focused on Biotechnology which prepares science professionals to fill management and leadership roles.</blockquote>

Shimadzu: Preparative Purification Solutions in Drug Discovery Synthesis

Preparative Purification Solutions in Drug Discovery Synthesis

Attend this webinar to learn more about our solutions for the preparative purification in the drug discovery space.

Preparative Purification Solutions in Drug Synthesis

Drugs of abuse LC-MS/MS analysis in whole blood can be challenging due to the complexity of the matrix. This challenge is amplified when targeting large panels of analytes spanning multiple drug classes, where matrix interferences and variability can significantly impact data quality. Robust and efficient sample preparation is essential to ensure accurate, reproducible results.In this webinar, we present a comparative study of solid-phase extraction (SPE), supported liquid extraction (SLE), and other protein and phospholipids removal extraction techniques. Using a broad panel of analytes spanning multiple drug classes, we evaluate each technique for recovery, matrix effects, and reproducibility. We also examine the role of automation in streamlining the sample prep process, improving consistency, and supporting high-throughput analysis in clinical and forensic testing environments.<h5>By attending this presentation, you will:</h5><ul><li>Comparing the performance of SPE, SLE, PLD and PPT techniques for the extraction of drugs of abuse from whole blood, focusing on recovery, matrix effects, and reproducibility.</li><li>Evaluating the impact of sample preparation on the overall accuracy and reliability of LC-MS/MS analysis in forensic and clinical toxicology applications.</li><li>The benefits and considerations of automating sample prep workflows to increase throughput, reduce variability, and enhance lab efficiency.</li></ul><blockquote>Presenter: Kyle Dukes &nbsp;(Application Scientist, Biotage)Kyle Dukes is a dedicated Application Scientist at Biotage specializing in sample prep workflows for LC-MS/MS analysis in clinical, forensic toxicology and bioanalysis. He supports fellow scientists with analytical method development and optimization. &nbsp;Kyle holds a Master’s degree in Analytical Chemistry from Clemson University. esraa-abojasserPresenter: Esraa AboJasser (Analytical Testing Market Manager, Biotage)Esraa AboJasser is the Analytical Testing Market Manager for Biotage. She drives growth through developing and promoting innovative solutions that help laboratories enhance their sample prep workflows. With 10 years of experience in sample preparation and chromatography, she has helped scientists across multiple fields simplify workflows and achieve more reliable results. &nbsp;</blockquote>

Separation Science: Sample Prep Strategies for Multi-Class Drug Analysis in Whole Blood

Sample Prep Strategies for Multi-Class Drug Analysis in Whole Blood

In this webinar, we present a comparative study of SPE, SLE and other protein and phospholipids removal extraction techniques.

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