Dottie Donnelly Brienza’s Post

We're excited to share our latest publication: "Technology Transfer and Process Development of Danicopan to Enable Process Validation," now published in the ACS Journal of Organic Process Research & Development. Dive into the full article to explore the innovative approaches and detailed methodologies for technology transfer, process optimization, and regulatory compliance leading to regulatory approval of Voydeya in the US, EU, and Japan. Read more here: https://lnkd.in/eXVkuhVV #Pharma #DrugDevelopment

This paper well described identification and synthesis of 12 process impurities in #Baloxavir Marboxil #impurities #referencesstandards #pharmaceutical #synthesis #processdevelopment #apisynthesis #processimpurities #organicsynthesis #degradationimpurities #oxidativeimpurities #genotoxicimpurities

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Pharma companies, listen up! We're here to revolutionize your analysis process with A-TEEM and Aqualog, the compliance power couple you've been waiting for! Forget scrambling to meet FDA 21 CFR Part 11 regulations. We've got you covered with: EzPAT OPC UA: Seamless integration with your PAT software for effortless data communication. A-TEEM Direktor: User-friendly software that guides you through multivariate analysis, even if you're a chemistry newbie. ✨ United States Pharmacopeia validation: Peace of mind knowing your results are accurate and reliable. ️ Installation & Operational Qualification: Our service engineers ensure your Aqualog is up and running flawlessly. But compliance is just the beginning! A-TEEM and Aqualog offer: Faster analysis: Say goodbye to time-consuming chromatography! A-TEEM gets you answers in a flash. ⚡ Deeper insights: Unravel complex mixtures with A-TEEM's unique molecular fingerprinting. Reduced costs: Ditch the expensive chemicals and save money with A-TEEM's column-free technique. Easier workflow: A-TEEM Direktor takes the guesswork out of multivariate analysis, making it accessible to everyone. We're not just joining the pack, we're leading the charge! A-TEEM is a patented technology, giving you a competitive edge in the pharma market. Ready to unlock the power of A-TEEM and Aqualog? Contact us today and let's take your analysis to the next level! #A-TEEM #Aqualog #PharmaCompliance #MultivariateAnalysis #FasterResults #DeeperInsights #CostSavings #EasyWorkflow #Innovation #HORIBA

Did you know users can seamlessly manage their Metrc Processing Jobs within Canix? This helps ensure compliance while capturing crucial data on costs, labor, and processing. Dive into the details on our blog: https://lnkd.in/efyyUtdb

My latest work with the Renzo Luisi group is out now in Organic Letters. We report the generation and utilization of highly unstable 3-oxetanyllithium as a hitherto unexplored nucleophile leveraging flash technology. 3-Oxetanyllithium usually undergoes a deconstructive ring opening to allyl alcohol under classical batch conditions. Using flow technology, a range of different electrophiles are suitable reaction partners in this protocol, and we demonstrate the utility of this protocol in late-stage pharmaceutical analogue synthesis. https://lnkd.in/d7FMnr3P

How do process impurities incorporate in crystalline pharmaceutical powders? Last year, we combined data from 52 product-impurity pairs (mostly industrial crudes from Boehringer-Ingelheim and Merck) and found that, once we limit the study to impurities that incorporate at significant levels (>0.1%), there are two primary mechanisms of concern: lattice incorporation, and impurity precipitation. How would we deal with industrial scenarios where both of these mechanisms occur at the same time? See our follow-up work (continued collaboration with BI and Merck), now published in OPRD, where we provide diagnostics, thermodynamic models, and a process development workflow to aid impurity rejection. Part 1 describes the theory and examples with two model compounds: https://lnkd.in/erXpTQGf Part 2 describes three case studies from industry: https://lnkd.in/e-wqP-YM For the earlier study on impurity retention mechanisms, see: https://lnkd.in/eWpR7aF5 Thanks to all the authors for the many interesting discussions this year, and for such a great collaboration! Fredrik Nordstrom, Eric Sirota, Mitchell Paolello, Na Yao, Ph.D., Travis Armiger, Qi Jiang, James Nicholson, Joseph Kratz, Michael Toresco, Alexander Lipp, Dr. Swjatoslaw N. R. Witte, Manuel Henry, Scott Shultz. #crystallization #impurities #pharmaceuticalmanufacturing

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Bulk powder properties (BPPs) of small molecule pharmaceuticals are intricately regulated in the latter stages of API process development. These properties include critical factors such as solubility, density, flowability, and hygroscopicity, each influenced by a combination of particle characteristics, including particle size distribution (PSD), particle shape, moisture content, and chemical composition. The pursuit of optimal BPPs for specific APIs demands rigorous development efforts and judicious experimental design. Serabelisib (TAK117), a PI3K inhibitor discovered and developed by Takeda, represents one of the most challenging compounds in BPP optimization. Following an iterative crystallization process development, a scalable crystallization medium using DMSO as a solvent was emerged as the preferred choice among the three systems screened. #processdevelopment #pharmaceuticals #crystallization #crystal #pi3k #api #takeda #drugdevelopment #drugs #drugproduct https://lnkd.in/eiWgkR7Q

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