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By Ray Dogum, chief editor, Drug Discovery Online | On August 1, 2025, the Foundation for the National Institutes of Health (FNIH) released a Request for Information (RFI) inviting proposals for pilot projects to accelerate the development, validation, and regulatory acceptance of New Approach Methodologies (NAMs). For drug developers, participating in this process offers not only scientific collaboration but also the potential to co-develop regulatory-grade NAMs aligned with FDA and NIH priorities. | |
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| Using GPS Engineering To Optimize Antibody-Based Drug Development | Application Note | By Jennifer A. Codding-Bui, Kaare Bjerregaard-Andersen, Cyrill Brunner, et al., ATUM | Explore the results collected when a platform designed with ML-guided GPS engineering was applied to develop a lead molecule targeting a mechanism in neuronal disease. |
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| "Ultra High” Potency Development And Manufacture | Case Study | Cambrex | A biotech with limited experience in the development and manufacture of high potency compounds sought to develop a process for producing a highly potent API used to treat an unmet oncology need. |
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| A Holistic Approach To Process Scale-Up | Webinar | Sartorius | Explore an innovative concept that optimizes USP and DSP processes, as well as discover scale-up results and a fully automated and integrative DSP system. |
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| A Duplex Assay For Quantification And Qualification Of AAV | Application Note | By Carey Carver, Yotam Blech-Hermoni, and James Qin, QIAGEN | Adeno-associated virus is a key gene therapy vector. Explore how digital PCR offers precise, standard-free quantification with improved consistency and inhibitor tolerance over traditional qPCR methods. |
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