USP Science & Research

?? Naiffer Romero, Principal Scientist, USP is one of the five experts featured in a new five-part series 'Trends and Challenges in Nitrosamine Testing', published by The Analytical Scientist on the challenges posed by nitrosamine impurities in pharmaceuticals. Read Part One, 'Scoping the Problem,' in which Naiffer and the others set the stage for the series by discussing when nitrosamines first got their attention, the types, and risk levels. https://ow.ly/6msb50Vbaqr Share this post or leave a comment below ?? to receive alerts when future parts of the series go live. In Part Two, the experts will discuss the main analytical challenges associated with nitrosamines. Kevin E. Parker Jessica Hoskins Alan Thompson Jingyue Yang #USPScience #nitrosamines

?? New USP event! USP and Lennox are excited to invite you to our upcoming user forum in Cork this April! Join us for insightful discussions and networking opportunities with industry experts and peers. Agenda: ?? Learn about the latest regulatory and industry updates on Nitrosamines ?? Learn how Pharmacopeial reference standards enable conclusive results and what risks are related to secondary standards. Registration info is here ??: https://ow.ly/fZ2550VqyIY #USPScience #UserForum

??Don't miss the 2025 DIA/USP Evolution of Biosimilars Development Workshop, where top experts and regulators will explore the latest scientific and regulatory advancements in biosimilars. If you work in this space, this is an opportunity you don’t want to miss. Let’s learn and grow together—register now! https://ow.ly/NQ1Q50Vq3tQ #USPScience #Biosimilars #Biotech #DrugDevelopment #DIA2025

Interested in controlling peptide impurities? Our next webinar is perfect for anyone involved in peptide drug development and quality assurance. Register today ??: https://ow.ly/CBLE50VnJE9 #USPScience #PeptidePurity

?? New USP event! USP and Lennox are excited to invite you to our upcoming user forum in Dublin this April! Join us for insightful discussions and networking opportunities with industry experts and peers. Agenda: ?? Learn about the latest regulatory and industry updates on Nitrosamines ?? Learn how Pharmacopeial reference standards enable conclusive results and what risks are related to secondary standards. Registration info is here ?? : https://ow.ly/b0p750VnqTL #USPScience #userforum

?? Save the Date! The Pharma Ed Resources Events Extractables & Leachables Summit 2025 in Philadelphia, PA is a two-day conference that will examine the safety, quality, and regulatory requirements for drug products. We will share an update on regulatory issues involved in wide-ranging contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteralhe finalized system suitability standards proposals for the analysis of organic extractable and leachables. Prabhakar Reddy, Director, Pharmaceutical Science & RAVIKIRAN KAJA Ph.D, Senior Principal Scientist, will speak during the event. Event and registration information is available here ??: https://ow.ly/KHe650VkHpJ #USPScience #Extractables #Leachables

Looking to learn about the latest regulatory and industry updates on Nitrosamines or how the pharmacopeial reference standards will enable conclusive results for your laboratory? ?? Lennox and US Pharmacopeia are delighted to bring customers in Dublin and Cork the USP User Forum Ireland 2025 in April. ??Dublin: 9:00am - 2:30pm, Tuesday 8th April 2025, Clayton Hotel Leopardstown, Dublin, D18 K2P1 ??Cork: 9:00am - 2:30pm, Thursday 10th April 2025, Raddison Blu Cork, Ditchley House, Little Island, T45 WF53 As a trusted source for quality, USP and several quality industry leaders will discuss quality issues and regulatory updates that laboratories face daily ?? Meet. Connect. Discover. Sign up for Dublin: https://lnkd.in/eJS3DBQT Sign up for Cork: https://lnkd.in/em-KA7yu #Usp #Uspharmacopeia #LennoxandYou USP Science & Research

?? Accurate AAV quantification just got easier! Learn more about USP’s gene therapy solutions designed to support AAV drug product development. Engineered to optimize analytical methods and enhance regulatory confidence, our standards are essential tools for reliable and reproducible AAV measurements. ?? What challenges do you face in AAV quantification? Share your thoughts in the comments! ?? Stay tuned as we continue expanding our portfolio of reference products to support the evolving needs of the biopharmaceutical industry. https://ow.ly/LQYF50VjW9s #USPScience #AAVQuantification #GeneTherapy

Excited to share that I've been invited to join a panel discussion, to discuss how our recent study can enhance Process Analytical Technology (PAT) applications! In this panel, we'll explore insights from our research published in AAPS Open, highlighting practical ways our findings can support advancements in PAT implementation. Check out the study here: https://lnkd.in/e-uX9Pph Looking forward to a great discussion!

?? New Webinar Alert! This webinar will address stakeholders’ needs on how to use USP advanced analytical techniques using chapter approaches, provide stakeholders with a clear understanding of General Chapters (<312> to <316>), LG polymer standards, and review the corresponding case studies and applications. Learning Objectives: ·??Evaluate the development of General Chapters <312> to <316> as modern analytical tools for use in conjunction with individual monographs ·??Implement innovative compendial standards and scientific methodologies by leveraging advancements in regulatory science ·??Understand USP’s holistic approach for Lactide-Glycolide or Lactic Acid-Glycolic Acid (LG) polymers, functionality of LG Polymers, and drug product performance Register now ?? : https://ow.ly/WCKs50VeVmq #USPScience #LGPolymers