BIOBOSTON CONSULTING

𝟳𝟬% 𝗼𝗳 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 𝗙𝗮𝗶𝗹 𝗗𝘂𝗲 𝘁𝗼 𝗗𝗲𝗹𝗮𝘆𝘀: 𝗛𝗼𝘄 𝘁𝗼 𝗙𝗶𝘅 𝗬𝗼𝘂𝗿 𝗟𝗼𝗴𝗶𝘀𝘁𝗶𝗰𝘀 𝘁𝗼 𝗔𝘃𝗼𝗶𝗱 𝗖𝗼𝘀𝘁𝗹𝘆 𝗠𝗶𝘀𝘁𝗮𝗸𝗲𝘀 https://lnkd.in/e97BFMec #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda Get in touch 👉  https://lnkd.in/eaqqYzQk

𝗗𝘂𝗮𝗹 𝗮𝗰𝘁𝗶𝗼𝗻 𝗮𝗻𝘁𝗶𝗯𝗶𝗼𝘁𝗶𝗰 𝗰𝗼𝘂𝗹𝗱 𝗺𝗮𝗸𝗲 𝗯𝗮𝗰𝘁𝗲𝗿𝗶𝗮𝗹 𝗿𝗲𝘀𝗶𝘀𝘁𝗮𝗻𝗰𝗲 𝗻𝗲𝗮𝗿𝗹𝘆 𝗶𝗺𝗽𝗼𝘀𝘀𝗶𝗯𝗹𝗲 A new antibiotic that works by disrupting two different cellular targets would make it 100 million times more difficult for bacteria to evolve resistance, according to new research from the University of Illinois Chicago. Researchers from UIC, in a new study published in Nature Chemical Biology, explored how synthetic antibiotics called macrolones combat bacterial infections by disrupting protein production or corrupting DNA structure. 🔬 Macrolones uniquely combine the mechanisms of macrolides and fluoroquinolones, making bacterial resistance nearly impossible due to the dual attack. 📄 Polikanov's team discovered that macrolones bind more effectively to ribosomes, even in resistant strains, without triggering resistance genes. The most promising macrolone effectively targets both ribosomes and DNA gyrase at low doses, complicating bacterial defense mechanisms. ➡ The interdisciplinary collaboration at UIC underscores the potential of optimizing macrolones for dual-target efficacy in future antibiotic development. Get in touch 👉  https://lnkd.in/eaqqYzQk

𝗨𝗻𝗹𝗼𝗰𝗸𝗶𝗻𝗴 𝗦𝘂𝗰𝗰𝗲𝘀𝘀: 𝟳 𝗔𝗹𝗮𝗿𝗺𝗶𝗻𝗴 𝗦𝘁𝗮𝘁𝗶𝘀𝘁𝗶𝗰𝘀 𝗼𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗣𝗹𝗮𝗻𝘀 𝗬𝗼𝘂 𝗖𝗮𝗻'𝘁 𝗜𝗴𝗻𝗼𝗿𝗲 https://lnkd.in/eQEiPwze #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda Free consultation 👉https://lnkd.in/e52sdG3P

𝗨𝗻𝗹𝗼𝗰𝗸𝗶𝗻𝗴 𝗦𝘂𝗰𝗰𝗲𝘀𝘀: 𝟳 𝗔𝗹𝗮𝗿𝗺𝗶𝗻𝗴 𝗦𝘁𝗮𝘁𝗶𝘀𝘁𝗶𝗰𝘀 𝗼𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗣𝗹𝗮𝗻𝘀 𝗬𝗼𝘂 𝗖𝗮𝗻'𝘁 𝗜𝗴𝗻𝗼𝗿𝗲 https://lnkd.in/eQEiPwze #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda Free consultation 👉https://lnkd.in/e52sdG3P

𝗙𝗗𝗔 𝗱𝗿𝗮𝗳𝘁 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗮𝗱𝗱𝗿𝗲𝘀𝘀𝗲𝘀 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 The FDA's draft guidance issued on Monday provides detailed instructions on how manufacturers should report postapproval manufacturing changes for licensed biosimilar and interchangeable products. This guidance is presented in a question-and-answer format and addresses common queries related to postapproval changes, fulfilling a commitment made in the 2022 reauthorization of the Biosimilar User Fee Act (BsUFA III) for fiscal years 2023 through 2027. 𝗖𝗮𝘁𝗲𝗴𝗼𝗿𝗶𝗲𝘀 𝗼𝗳 𝗣𝗼𝘀𝘁𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗖𝗵𝗮𝗻𝗴𝗲𝘀: 🔹 Major Changes: Require the filing of a Prior Approval Supplement (PAS). 🔹 Moderate Changes: Require the filing of a Changes Being Effected-30 days supplement (CBE-30). 🔹 Minor Changes: Require only the filing of an annual report. 𝗖𝗼𝗺𝗽𝗮𝗿𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗦𝘁𝘂𝗱𝗶𝗲𝘀: Manufacturers should use well-qualified, in-house reference materials for comparability studies to evaluate the impact of manufacturing changes on biosimilar or interchangeable biosimilar products. 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻 𝗶𝗻𝘁𝗼 𝗠𝘂𝗹𝘁𝗶𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗙𝗮𝗰𝗶𝗹𝗶𝘁𝗶𝗲𝘀: Risks associated with introducing a licensed biosimilar or interchangeable biosimilar into a multiproduct manufacturing area or contract manufacturing facility must be assessed. Control measures should ensure the product meets its quality characteristics, including purity, with identity testing as a key tool. 𝗔𝗱𝗵𝗲𝗿𝗲𝗻𝗰𝗲 𝘁𝗼 𝗜𝗖𝗛 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲: Applicants are advised to follow the International Council for Harmonization’s (ICH) Q5E guidance on biotech comparability, issued in June 2005, when making manufacturing changes to licensed biosimilar or interchangeable biosimilar products. The draft guidance aims to clarify and streamline the process for reporting manufacturing changes for biosimilar and interchangeable biosimilar products, ensuring that quality and safety are maintained while accommodating advancements and changes in manufacturing practices. By following these guidelines, manufacturers can better navigate regulatory requirements and maintain compliance with FDA standards. Free consultation 👉https://lnkd.in/e52sdG3P

𝟳𝟬% 𝗼𝗳 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 𝗙𝗮𝗰𝗲 𝗗𝗮𝘁𝗮 𝗕𝗿𝗲𝗮𝗰𝗵𝗲𝘀: 𝗪𝗵𝘆 𝗬𝗼𝘂𝗿 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗖𝗼𝘂𝗹𝗱 𝗕𝗲 𝗮𝘁 𝗥𝗶𝘀𝗸 https://lnkd.in/esrgS-Zy #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda Get in touch 👉 https://lnkd.in/eaqqYzQk

𝟳𝟬% 𝗼𝗳 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 𝗙𝗮𝗰𝗲 𝗗𝗮𝘁𝗮 𝗕𝗿𝗲𝗮𝗰𝗵𝗲𝘀: 𝗪𝗵𝘆 𝗬𝗼𝘂𝗿 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗖𝗼𝘂𝗹𝗱 𝗕𝗲 𝗮𝘁 𝗥𝗶𝘀𝗸 https://lnkd.in/esrgS-Zy #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda Get in touch 👉  https://lnkd.in/eaqqYzQk

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