USP Science & Research

💡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

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

USP is developing a suite of reference standards and analytical reference materials to support the characterization of AAV viral vectors and the assessment of common impurities, such as residual plasmid and genomic DNA. Read more about how USP is working to improve the quality and safety of AAV drug products in this article authored by Anthony Blaszczyk and featured in Cell & Gene. ➡️:https://ow.ly/i7S250V5JBm #USPScience #GeneTherapy #AAV #Biologics

📢 New webinar alert! Episode 14 of the Waters Corporation webinar series will explore analytical techniques for evaluating the efficacy, safety, and quality of polysaccharide vaccines. Panelists include Mandy Alger, Senior Scientist II, Global Biologics USP, and Katayoun Morakabi (Waters | Wyatt Technology). Isabelle Vu Trieu (Waters Corporation) will moderate this discussion. Register today! ➡️ https://ow.ly/bhqT50V3J52 #USPScience #PolysaccharideVaccines

Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings https://lnkd.in/e6rEWHRR - By Josh Erickson, senior director, microbiology pipeline and operations, US Pharmacopeia For both cGMP facilities and sterile compounding pharmacies, environmental monitoring (EM) is fundamental in ensuring that environmental conditions do not compromise the quality of the therapeutic products produced.

How challenging is it to detect NDSRIs (Nitrosamine Drug Substance-Related Impurities)? Watch the teaser now and get a sneak peek into the discussion! In this teaser from the first episode of ‘Nitrosamine Uncovered’, Dr. D.Vijaya Bharathi and Mayank Bhanti, Ph.D. unpacks the major analytical challenges one after another, highlighting the complex hurdles pharma manufacturers face in ensuring patient safety. 📢 What are your biggest challenges in NDSRIs detection? Drop your thoughts in the comments! 👇 Stay tuned for the full episode, where we uncover deeper insights into analytical challenges and solutions for pharma manufacturers.

Exciting News! US Pharmacopeia is thrilled to unveil our new Analytical Reference Material (ARM) for #AAV drug product development! Introducing the Plasmid for Residual DNA Quantification ARM (https://lnkd.in/eRY3dvYH) – your control and system suitability tool for PCR analytical methods. This ARM ensures the accuracy and reliability of your processes, taking your work to the next level! Stay tuned for more updates as we continue to expand our portfolio of reference products to meet the evolving needs of the biopharmaceutical industry.

With heightened scrutiny focused on synthetic food colors, natural colors are gaining popularity as a viable alternative. However, food colors from natural sources can come with their own risks. Access Appendix XXI: Guidelines for the Control of Contaminants in Food Colors from Natural Sources, for information on how to maintain the quality and safety of your products with confidence. For more new standards, revisions, and updates, access our December 2024 issue of #FCC Forum:    New monographs: Sodium Silicate and Sacha Inchi Oil Revised monographs: Bentonite, Carbon, Activated, Diatomaceous Earth, Ethoxyquin, Fructose, Galacto-oligosaccharides, Taurine and Titanium Dioxide Omissions: Brominated Vegetable Oil Stay up-to-date and submit your feedback on our new and revised standards: https://lnkd.in/eMSiQ_xu #foodsafety #naturalcolors #FoodChemicalsCodex #USP

I work at US Pharmacopeia (USP), an organization dedicated to setting quality standards for medicines worldwide. Our mission is to ensure the availability of safe, effective, and high-quality medicines by establishing rigorous scientific standards that manufacturers must meet. At USP, we develop official monographs (documentary standards) that outline key specifications and testing methods for pharmaceutical products. We also provide reference standards (physical materials) that serve as benchmarks for verifying identity, purity, and potency. Our work extends beyond active pharmaceutical ingredients (APIs) to include excipients (inactive ingredients), ensuring that every component of a medicine meets strict quality expectations. Additionally, we establish performance tests such as dissolution testing, which verifies that medicines release their active ingredient in a way that allows the body to absorb it properly. These comprehensive quality solutions support pharmaceutical companies in developing and manufacturing medicines that patients can trust. By continuously updating and refining these standards, USP plays a critical role in strengthening the global medicine supply chain and advancing public health. #QualityMatters #PublicHealth #USPStandards #MedicineQuality US Pharmacopeia USP India

📢 New webinar alert! Episode 13 of the Waters Corporation webinar series will provide an overview of the principles and practical guidance regarding the LC-MS-based peptide mapping approach of the multi-attribute method (MAM) for therapeutic proteins as described in the proposed USP General Chapter <1060>. Panelists Sheila Mugabe, Sr. Scientist, USP and Ying Qing Yu, Dir. of Biopharmaceutical Science and Evaluation, Waters Corporation will discuss considerations for system readiness and enhancements to the robustness of MAM workflows. Register today! ➡️ https://ow.ly/jMlI50UVUWc #USPScience #MultiAttributeMethod