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| 2026 ISPE AI in Life Sciences Summit – Powered by GAMP® | The 2026 ISPE AI in Life Sciences Summit – Powered by GAMP® will be held 22–23 June in Boston, offering insight into how AI is advancing within the life sciences sector. Sessions explore model governance, data integrity, explainability, and inspection ready design. Attendees gain practical frameworks for integrating AI into GxP workflows and guidance on how to meet evolving regulatory expectations. LEARN MORE |
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By Kalie E. Richardson, Karla L. Palmer, and Dara Katcher Levy, Hyman, Phelps & McNamara | FDA won't offer a waiver process or phased implementation. Instead, the agency is providing a seven-year runway to transition to a new labeling format. | |
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| Key Metrics In Antibody Drug Development | Webinar | TA Instruments | Explore key techniques like DSC and Rheology to assess thermal stability and viscosity in antibody drug development. Gain practical insights to enhance biologic candidate selection, formulation, and delivery. |
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FOCUS ON DOWNSTREAM MANUFACTURING |
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| Guide To PUPSIT And Annex 1 In Aseptic Processing | Article | Cytiva | Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions. |
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| High Purity And Recovery With Adjustable Selectivity | Application Note | Bio-Rad Laboratories, Inc. | Uncover a resin that enables high-yield purification of complex biomolecules, as well as supports fast flow rates, consistent recovery, and scalable performance for downstream processing. |
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DOWNSTREAM MANUFACTURING SOLUTIONS |
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