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What Your Material Specification Sheet Doesn’t Tell You

When it comes to selecting materials for your next innovative product, the material specification sheet is likely the first place that you will turn. This document provides core properties measured by the manufacturer and serves as an essential tool for supplier verification and new product development. However, while these sheets are reliable and provide a standard method for comparison, they often fail to tell the whole story.

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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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Linear Viscoelastic Region: Why It’s Crucial in Materials Testing

Our world is brimming with viscoelastic materials: The dough you knead before baking a fresh loaf, the Silly Putty your toddler slaps against the wall, the rubber gaskets that create an airtight seal on an airplane door. Testing those materials by applying controlled deformations (strains) or forces (stresses) at various timescales, temperatures, and/or humidities allows for the optimization of properties and ensures durability and safety.

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Why DSC Testing is a Critical Step in Developing Biosimilar Drugs

Biologic therapies derived from living organisms have revolutionized the treatment of complex diseases, yet their high development costs are often passed onto patients. Biosimilar drugs offer a promising solution to reduce costs while maintaining therapeutic efficacy. Unlike generic drugs, biosimilars cannot be exact replicas of their reference biologics due to their complex structures, necessitating rigorous testing and regulatory approval.

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Overcoming Composites R&D Challenges with Material Analysis

The composites market is evolving fast. Global market projections indicate a 10.8 % growth by 2028, driven by the demand for composites across industries looking for materials with superior performance at reduced weight and cost. This blog explores how advanced material analysis can enhance R&D and manufacturing processes in the composites market, ultimately leading to financial savings and increased efficiency.

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Waters New Rapid Screening-DSC Enables Up to 24x Faster Thermal Stability Testing at Ultra-Low Sample Volumes for Antibody Drugs

MILFORD, Mass. – July 23, 2024 – Waters Corporation (NYSE:WAT) announced today the global release of the TA Instruments™ Rapid Screening-Differential Scanning Calorimeter (TA Instruments RS-DSC), designed for biopharmaceutical developers. The TA Instruments RS-DSC is a high-throughput DSC for precise thermal stability testing of high-concentration biologic formulations specifically for antibody drugs and engineered proteins.

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How to Accelerate Thermal Stability Testing for High-Concentration Drugs

The stability of high-concentration drugs can change under storage conditions, but until now, thermal testing in the lab using traditional calorimetry methods has been time-consuming and challenging. The new TA Instruments RS-DSC fills a critical antibody formulation development gap by allowing for high-throughput short-term thermal stability testing at formulation strength concentrations. In this blog, we explore why that’s essential.

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