Nitrosamine Exchange – a USP’s knowledge community for all-things Nitrosamine T he Nitrosamine impurities crisis prompted regulators around the world to increase their scrutiny of drug manufacturing processes even further. In the future, this greater scrutiny may lead to the discovery of nitrosamine impurities in other medicines. For this reason, manufacturers need to understand which medicines are likely to form nitrosamines, how and at what levels nitrosamine impurities are forming, and how to control nitrosamines. In the following seminar we will explore how USP responded to the nitrosamine impurities crisis not only with a proposed general chapter on nitrosamine impurities but also non-compendial resources and tools that provides a risk assessment strategy, methods for detecting and measuring nitrosamine impurities. In that effort, USP built a knowledge community dedicated to All-things Nitrosamines.   Register Here: Nitrosamine Exchange – a USP’s knowledge community for all-things Nitrosamine  -and- Set a reminder in the community by clicking YES I will attend, or add to your   calendar !  **By using the RSVP to set a reminder you can join the conversation around the event, or receive updates in the community.   Naiffer Romero has more than 18+ years of pharmaceutical industry experience. In his 10 years tenure with USP, he has served several roles: Lead scientist in performance testing compendial reference standards development, Manager in charge of LATAM Compendial engagement and education with stakeholders and national regulatory bodies. Romero is also a certified USP Education instructor. Most recently, he joined USP’s Scientific Affairs performance cell where he leads scientific outreach and engagement for LATAM & US region on key national health priority topics. His combined pharmaceutical expertise includes analytical development, salt and polymorph selection, development of dissolution methods, IVIVC modeling, and impurity analytical strategy. Romero also served as member of USP’s Nitrosamine Steering Committee and community host to ‘Nitrosamine Exchange’, a knowledge community in all-things nitrosamine. Naiffer also liaises technical discussions on pharmacopeial collaboration including International meeting of World Pharmacopeias (part of WHO).
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  In the development of biotherapeutics, a thorough understanding of a molecule’s product quality attributes (PQAs), and their effect on various structure-function relationships and long-term stability, is essential for ensuring the safety and efficacy of the product. At present, numerous routine chromatographic and electrophoretic assays are used to characterize and monitor individual PQAs. However, execution of multiple routine methods for batch release, stability time-points, and process/formulation development support becomes time and resource intensive, and often provides an indirect measure of biologically relevant PQAs. Introduced in 2015, the multi-attribute method (MAM), based on LC-MS peptide mapping and automation principles, provides simultaneous and site-specific detection, identification, quantitation, and quality control (monitoring) of PQAs.   A dedicated Pfizer team has been regularly employing MAM on an in-house MAM platform to support biotherapeutic process and product development. In parallel, this team has continually explored and implemented improvements in the Pfizer MAM platform, including sample preparation and data processing automation, to move toward the next generation of MAM. Recently, a pre-commercial demo model of the new Thermo Scientific Orbitrap Exploris MX mass detector was evaluated in-house by the Pfizer MAM team. Here, the results of the evaluation and an assessment of the Orbitrap Exploris MX mass detector’s suitability as a next generation MAM instrument are presented.   Learn: Pfizer MAM platform milestones for characterization and routine monitoring Automation of sample handling and data processing and reporting Evaluation and optimization of the Orbitrap Exploris MX mass detector for MAM REGISTER HERE
Webinars on June 8 and 9, 2022 | 10:00 BST | 11:00 CEST Registration page >    Analytical testing of soil quality, fertilizers, and agricultural products is critical to provide full transparency in the supply chain of food and feed and to protect consumers and producers. Join this two-part webinar series and discover a unique technological platform that enables you to perform all your elemental and isotope CHNSO analyses, while delivering simplicity and productivity to your laboratory.   Part 1: Elemental analysis of food, feed, and beverages Wednesday, June 08, 2022, 11:00 AM CEST Complexities in the food, feed and beverage supply chain require analytical solutions that will protect both consumers and producers. With the Thermo Scientific Elemental Analysis Platform, you can address QC, authenticity and origin of your samples through scalable, software-driven workflows that will provide you with the capabilities your lab needs today, with flexibility for the future   Part 2: Elemental analysis in agricultural practices Thursday, June 09, 2022, 11:00 AM CEST Soil and fertilizers testing are critical to sustain optimal growth and development for plants and to provide full transparency of food production for consumers. Thermo Scientific Elemental Analysis Platform enables you to perform all your wt% and isotope CHNSO analysis on one technological platform, delivering simplicity and productivity to your laboratory.   Learning points: Explore how wt% and isotope elemental analysis deliver QC, authenticity, and origin answers to variety of food and feed samples such as sugar, meat, rice, juice, dairy, tea or super-foods  Learn how to expand your capabilities with a flexible elemental analysis platform that grows with you   Learn about sample preparation, sample introduction and EA settings to integrate and optimize this technology in your routine analysis Who should attend: Lab managers and analysts that have analytical challenges in elemental analysis of food and feed samples   QA/QC and research laboratories that want to keep up to date and also be ready for future challenges  Scientists/chemists/analysts interested in using isotope fingerprints Speakers Dr. Liliana Krotz |  Application Manager OEA |  Thermo Fisher Scientific Graduated in biochemistry at the Faculty of Pharmacy and Biochemistry at the University of Buenos Aires, Argentina, Liliana had worked as researcher in the field of industrial chemistry before joining Thermo Fisher Scientific in 1994 as Global Product Specialist in Organic Elemental Analysis (OEA). Since 2019, in her role as OEA Application Manager, Liliana is supporting customers with technical and analytical demonstrations and numerous collaborations for the optimization of new analytical methods covering different application fields such as agronomy, marine science, environmental, and food and animal feed.   Dr. Oliver Kracht |  Senior Product Specialist EA-IRMS |  Thermo Fisher Scientific Oliver holds a university degree in Geoscience/Geochemistry and a PhD on dissolved organic matter at Max-Planck Institute for Biogeochemistry in Jena, Germany. He has been part of the gas IRMS team at Thermo Fisher Scientific Bremen for 20 years in his role as a Product Specialist and R&D Lab Engineer, focusing on water analysis, dual inlet techniques and coupling of elemental analyzers to IRMS.   Dr. Meike Fischer |  Product Specialist EA-IRMS |  Thermo Fisher Scientific After completing her PhD at the Max Planck Institute for Solar System Research, Geoscience Center Göttingen, Germany, Meike joined Thermo Fisher Scientific Bremen in 2021 as a Product Evaluation Specialist and supported development of the new software for gas IRMS – Qtegra ISDS Software. Since 2022 Meike has taken on Product Specialist role focusing on elemental analyzer instrumentation and gas equilibration analysis, developing applications and methods for isotope analysis in a variety of fields.
Join us for the second AnalyteGuru virtual trivia challenge - it's where science meets trivia June 24 at 10:00 CDT   If you missed our first Trivia challenge, or would like to defend your title, we would like to welcome you back for more! For one hour, attendees will participate in a fast-paced virtual game that promises to be fun and rewarding. Entertaining guest host Ryan Budds will remind you how much fun trivia can be, and we’re certain you’ll come back for more. Invite your friends and colleagues!  Meet Our Host | Trivia With Budds   Join the community to get more from the event. You must be a community member in order to: Showcase your standings in the leaderboard Receive a virtual "Trivia Guru" badge RSVP Receive updates and a reminder Converse with other attendees outside of the Trivia event Helpful Tips for Participating: To play, you don’t have to download or install any app — just use link to join and we’ll provide you a code to enter.  We recommend you use two devices — the game works best if you watch the event with our host on a computer (or any device with a browser) and use your smart phone to answer the questions. The challenge will comprise five rounds of Trivia gameplay and each round will include 10 questions. Participants will have 20 seconds to buzz in for each question and the faster you buzz in, the more points you will earn. When presented with a multiple-choice question, we recommend taking a guess if you are not certain of the answer - every point counts!
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Virtual Trivia Leaderboard

Please congratulate the winners to our latest trivia challenge!

  1. Helix_Heroes
  2. NMS
  3. erictague
Our second Trivia event is already scheduled for June 17, don't miss the chance to join. RSVP today - join as one or as a team!