Fran DeGrazio

We know that #coatingadditives can provide significant improvements in formulations...but how do they do it? 🤔 🧪📝 Our technical experts break down key coating additive functions in a series of guides that are succinct yet impactful reads for formulators and other technical experts. 🎨 Key additive functions that we uncover include: - Anti-skinning agents - Wetting and dispersing additives - Rheology modifiers 🚨 This series is COMING SOON and we want you to be the first to check it out. Click the link to learn more - https://brnw.ch/21wKOAL

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FDA expedited designation trends are a marker of innovation, promise, and momentum in the R&D pipeline, particularly for cutting-edge therapies. Earlier this year, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) declared that “accelerated approvals will be the norm”, especially for initial approvals of gene therapies. Six months later, this trend is indeed accelerating. What’s more, regenerative medicine advanced therapy RMAT requests and designations are emerging as a clear preference to other expedited pathways. Read our quarterly discussion on designation trends for advanced therapies to learn more about the basis for each individual therapy designation as well as commentary and analysis from recognized Parexel experts that offer additional context on data and findings. https://lnkd.in/eb9MN-z6 #CBER #Regulatory #RMAT #FDA

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𝐍𝐢𝐭𝐫𝐨𝐬𝐚𝐦𝐢𝐧𝐞 𝐮𝐩𝐝𝐚𝐭𝐞: The recent recall of Duloxetine capsules by Breckenridge Pharmaceutical underscores the significant challenges the pharmaceutical industry faces with nitrosamine contamination. On May 4, 2024, the FDA announced that Breckenridge issued a retail-level recall of duloxetine delayed-release capsules due to the presence of N-nitroso-duloxetine, a nitrosamine impurity, above acceptable limits. Nitrosamines, which can form during drug manufacturing, are a major concern due to their potential carcinogenic effects when present above safe levels. This incident highlights the critical need for stringent quality control measures and proactive efforts to detect and mitigate impurities in pharmaceuticals. Explore our range of high-purity nitrosamine and NDSRI reference materials to ensure your pharmaceutical testing complies with FDA and EMA standards: https://okt.to/a8fC3D #Pharmaceuticals #DrugSafety #Nitrosamines #FDA #QualityControl #pharmaindustry

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Tough day for Charles River Laboratories and the #SCDI. Today CRL is down ~12% as it lowered its 2024 FY projections. - For the second quarter of 2024, revenue was $1.03 billion, a decrease of 3.2% from $1.06 billion in the second quarter of 2023 - On a segment basis, organic revenue growth in the Manufacturing Solutions (Manufacturing) segment was more than offset by lower revenue in the Discovery and Safety Assessment (DSA) and Research Models and Services (RMS) segments - James C. Foster, Chair, President and Chief Executive Officer, said, “Our financial performance through the first half of this year has been largely in line with our initial outlook; however, forward-looking DSA trends suggest that demand will not improve during the second half of the year as we had previously anticipated, and in fact, will decline for global biopharmaceutical clients. This has caused us to take a much more negative view of our growth prospects for the second half of the year. We believe that our clients are currently more focused on reassessing their budgets and reprioritizing their pipelines, but continue to view strategic outsourcing as a compelling solution to improve their cost efficiency and speed to market, presenting a longer-term opportunity for us.” #pharmaceuticals #biotechnology #clinicaltrials #clinicalresearch #preclinical

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Monitor your viable and non-viable particles according to the most recent regulatory requirements. Count, report, document and manage your pharmaceutical environmental monitoring data meeting 21 CFR Part 11 data integrity requirements. The robust and flexible system architecture from Particle Measuring Systems (PMS) ensures pharmaceutical cleanroom environmental monitoring data is protected and available whenever there is a need for product release and reporting. Solutions for all pharmaceutical cleanroom sizes and classes to fit most budgets. Detection – Sensors Viable and non viable samplers from a single manufacturer. Wide variety of analog sensors available including TRH, DAP, Air Flow velocity, etc. Digital inputs and outputs to interface with a selection of operational processes. Data and Process Management Software Get actionable insights with the combination of FacilityPro Processors and Pharmaintegrity™ Data Management Software. Designed for GMP and 21 CFR Part 11 compliance, this Environmental Monitoring package includes workload, data and process management, inventory control, and scheduling–all based on identifiable sample locations. Particle Measuring Systems, Nina Morton, Stacy Duncan, Pharmaceutical Online

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