?? 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 7,936 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.
- 网站
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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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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 #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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Are you involved in supporting pharmaceutical microbiology, environmental monitoring, aseptic processing and/or sterility assurance at your organization? Then this USP education and training course is designed for you! This course CM-1229-01 titled “Sterilization and Sterility Assurance” will provide a comprehensive understanding of the key requirements outlined in USP general chapters: USP <1116> Microbiological Evaluation of Aseptic Processing Environments USP <1211> Sterility Assurance USP <1229> Sterilization of Compendial Articles Join myself and US Pharmacopeia on March 6th, 2025 from 0830-1630 EST. Anyone can register, from any part of the world! Bring me all your questions. Registration link in the comments below, hope to see you there! Email questions to [email protected]. #SterilityAssurance #Sterillization
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??Don't miss out – register today! https://ow.ly/kTO750V9EzE #USPScience #mRNATherapeutics
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?? Did you know that our peptide and excipient monographs, chapters, reference standards and new analytical reference materials give peptide manufacturers confidence when developing and manufacturing these high-quality medicines? Watch the video below ??to learn more about our peptide solutions and share with your network! #USPScience #ReferenceStandards #Peptides
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??Manufacturers of biosimilars, such as those for Etanercept, must demonstrate their products are as safe and effective as their originator counterparts. Establishing reference standards early in product development can reduce risks at later stages. The NEW USP Etanercept for Bioassays Reference Standard is a valuable tool for supporting analytical method development, validation, and technology transfer. Our Reference Standard ensures you can confidently evaluate the biological activity of etanercept, which is essential for achieving its intended therapeutic effect and ensuring patient safety. Learn more about this reference standard ??: https://ow.ly/xBj950V8njJ #USPScience #Bioassay #etanercept
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2 DAYS LEFT – REGISTER NOW BEFORE IT'S TOO LATE! In just 2 days, join us for USP Science & Research's Introduction to Rapid Microbiological Methods course, happening live on February 27, 2025, from 8:30 a.m. to 12:30 p.m. EST. This blended learning program will provide a thorough understanding of the latest advancements in Rapid Microbiological Methods (RMMs), focusing on cutting-edge technologies and techniques used in the pharmaceutical industry. You’ll learn about the key differences between growth-based and non-growth-based methods, explore technologies used in the detection of contamination in short-life products, and gain valuable insights into the validation and implementation of these methods. The course covers critical USP-NF General Chapters, including: USP <72>: Respiration-Based Microbiological Methods USP <73>: ATP Bioluminescence-Based Microbiological Methods USP <1071>: Rapid Microbiological Methods, Risk-Based Approach Additionally, Virtuosi?, powered by Quality Executive Partners, Inc. (QxP?), will provide two self-paced video modules on Sterility Testing and Bacterial Endotoxin Testing, covering the materials, methods, and tools used for implementation, as well as how to interpret results and address endotoxin concerns. Don’t miss out on this opportunity to learn from industry experts: Huiping Tu, Ph.D., Senior Principal Scientist, USP Tyler DeWitt, Ph.D., Technical Consultant, QxP Vanessa Figueroa, Executive Director of Microbiology, QxP Register now to secure your spot: https://lnkd.in/gyHPSPtJ #pharma #biopharma #biotech #qualityassurance #training