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Getting the Rheology Right for Generic Topical Pharma Submissions

Summary For any generic pharmaceutical developer submitting a new drug application, the process of demonstrating the equivalence of a topical pharmaceutical to a reference listed drug can be a grueling process. Not least of the challenges facing regulatory affairs personnel is navigating the often-daunting landscape of rheological measurements. Agencies such as the FDA and EMA…

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RS-DSC Product Demonstration

Product Demonstration RS-DSC Product Demonstration: A Dilution-Free Method for Screening Thermal Stability of High Concentration Biotherapeutics Discover the Future of Thermal Stability Testing with the RS-DSC When it comes to antibody drug products, ensuring short-term thermal stability is crucial for maintaining quality and securing regulatory approval. The TA Instruments™ RS-DSC (Rapid Screening-Differential Scanning Calorimeter) revolutionizes…

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Comprehensive Rheological Characterization to Optimize Electrode Manufacturing

Summary Electrode manufacturing for lithium-ion batteries is a complex, multistep process that requires comprehensive material characterization to ensure quality and consistency in the final electrodes. Electrode processing involves combining active materials with binders and conductive additives to form a coating on the current collector, either as a slurry or dry coating. The mixing and coating…

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