?? 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
USP Science & Research
制药业
20852，Rockville 8,028 位关注者
Building trust through rigorous science & standards that ensure quality.
关于我们
Scientific research and the expertise of our staff and volunteers are at the root of our work in advancing public health by ensuring the quality and safety of medicines, dietary supplements, and food ingredients. We are committed to rigorous science to help protect patient safety, build trust in our public quality standards setting, and improving the health of people around the world.
We invite scientists, academics, regulatory professionals, healthcare practitioners, thought leaders, and others to follow this page to stay informed on our latest research publications and announcements on opportunities to serve as decision-makers and advisors on USP’s councils, committees, and panels.
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https://www.usp.org/our-science
USP Science & Research的外部链接
- 所属行业
- 制药业
- 规模
- 1,001-5,000 人
- 总部
- 20852，Rockville
- 创立
- 1820
- 领域
- nonprofit、standards setting和medicines quality standards
动态
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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
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?? 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
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?? 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
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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
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?? 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
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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!
?? Want to explore the latest developments and biggest challenges in process analytical technology (PAT) today? Yang Liu and the rest of the speaker panel will: ? Share their own experience on best practice when incorporating PAT to aid pharmaceutical processes. ? Discover the applications of the technology, innovative PAT tools, as well as addressing obstacles to its broader adoption in the pharmaceutical industry. Register a place using this link >>> https://bit.ly/3D1SeSG 908 Devices Bruker BioSpin #PAT #pharmaceutical #analytical #technology
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?? 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
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Please join us to learn more about current analytical approaches to develop and ensure the quality of #mRNA therapeutics and vaccines. Your input is important to advance new public standards for these products. Registration is free so use the link below to reserve your spot!
Join us for USP’s mRNA Virtual Summit on March 11-12, 2024, where industry leaders, scientists, and regulatory experts will discuss the latest advancements, challenges, and solutions in mRNA therapeutics and vaccines. This two-day event will cover critical quality attributes (CQAs), analytical strategies, raw material standards, and regulatory considerations, providing key insights to advance mRNA research, development, and manufacturing. Don’t miss this opportunity to engage with thought leaders and explore innovations shaping the future of mRNA technology. Register now! Learn more here. https://lnkd.in/eEnSSdBn #mRNA #quality
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US Pharmacopeia is pleased to have contributed to the new report, A Path Forward: Collaborative Solutions to Strengthen Canada’s Drug Supply, released by the Canadian Generic Pharmaceutical Association (CGPA) and the Canadian Association for Pharmacy Distribution Management (CAPDM). This important initiative brought together key pharmaceutical supply chain and healthcare stakeholders—including manufacturers, distributors, healthcare professional organizations, federal and provincial governments, hospital GPOs, academia, and more—to develop priority actions to address drug shortages in Canada. At USP, we remain committed to working with global partners to enhance the resilience and security of medicine supply chains, ensuring patients have access to the quality medicines they need. ?? Click here to read the report: https://lnkd.in/g-UzfmsR #SupplyChain #DrugShortages #Pharmaceuticals #Healthcare #Collaboration #USP #CGPA #CAPDM Rebecca Cambronero, MBA, MSL, PMP Chris Colwell Kristin Willemsen Matt Christian Amy Sonderman
Drug shortages continue to rise in Canada and around the world, posing a growing threat to our already strained healthcare system and the reliable supply of essential medicines. In response to this complex threat, CGPA has teamed with the Canadian Association for Pharmacy Distribution Management (CAPDM) to develop a new report that outlines key solutions to build a more resilient pharmaceutical supply chain. A Path Forward: Collaborative Solutions to Strengthen Canada’s Drug Supply highlights the importance of early collaboration, regulatory harmonization, and supply chain diversification to improve access to essential medicines, while emphasizing the need for sustainable pricing for critical drugs and increased buffer stock to help mitigate shortages. Drug shortages are a complex issue, but through collaboration and innovation, we can strengthen Canada’s drug supply and ensure patients have access to the medicines they need. Click here to read the report: https://lnkd.in/g-UzfmsR
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