Ensuring Integrity of Drug Formulation from Development to QC

After a small molecule has been identified as a viable drug candidate, substantial testing is required to assure that chemical and structural integrity are preserved throughout the drug development process to maintain its functionality. To keep a balance between quality and manufacturability, time-consuming and labor-intensive testing and analysis are required to demonstrate that chemical integrity is intact. Among the techniques used to study changes in chemical integrity are infrared and Raman spectroscopy.
 This webcast will discuss where efficiencies can be made in data collection, regulatory compliance, instrument qualification, method validation, and data integrity all along the development pipeline up to final quality control (QC) testing. Learn how to quickly identify changes in polymorphic structure, monitor API to excipient distribution, and troubleshoot out-of-specification (OOS) product lots, while preserving data integrity needed for audits.
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OTHER ON-DEMAND WEBINARS

CryoEM for Drug Discovery

nvidia

Cryo-electron microscopy (cryoEM) is a Nobel Prize-winning technique for solving high-resolution three-dimensional structures of biological molecules such as proteins, that is used for structure-based drug design. Key to the success of cryoEM are significant advances in high performance computer vision and machine learning algorithms, used to extract information from large numbers of noisy 2D microscope images and compute and refine 3D structures of target proteins in near-native states.
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Increase Sensitivity and Reliability for Biopharmaceutical Applications by Simple Improvements in Sample Preparation

chromatographyonline

Sample preparation is an essential step for analytical chromatography, and recently biopharmaceutical analysts are discovering the need for cleaner, concentrated and targeted sample preparation methods for large molecules. This webcast will introduce how to properly clean up and isolate monoclonal antibodies (mAbs) using a high capacity paramagnetic bead solution, demonstrate how to optimize clean-up of excess labeling reagent, salts, or surfactants before N-glycans analysis, and how to utilize a multi-mode polymeric SPE for concentrating, solvent switching and sensitivity of samples.
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Variant Assessment for Reduced Penetrance Diseases

Ambry Genetics

Heritable disorders can often be linked back to a specific gene or genetic variant which transmits the risk of disease across generations. In most cases, the penetrance, or risk of being affected by the disease, for a pathogenic variant carrier is less than 100%. For an increasing number of disorders, the penetrance is even lower (20-50%), which begins to confound our ability to understand the relationship between disease risk and a specific genetic variant. At this level, classical tools, including family and functional studies, for assessment of variant pathogenicity loose power. This webinar will address the utility of the different lines of evidence in the classification of variants in moderate penetrance disease and recommended modifications to multivariate analysis in this setting.
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Accelerate your Drug Development process with Lonza Engine™

Pharmtech

Speed and quality are key in pharmaceutical manufacturing. How can your equipment add value to your production process? Join the Lonza team to discover how the new Lonza Engine™ equipment portfolio is designed to support bioavailability enhancement, encapsulation and early-phase clinical development technologies.
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