The Drug Supply Chain Security Act (DSCSA) has its final deadline approaching in November 2023. To confirm that only trusted entities are involved in the exchange of prescription drugs, one of the lesser thought-about elements mandates that the required data exchange through the supply chain is only done with authorized and registered trading partners.
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pharmtech
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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Poorly soluble drugs for oral administration present unique formulation challenges, particularly during early development. Formulation in a lipid-based carrier can be a feasible approach, but usually requires extensive testing to find suitable excipient combination.
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biopharma-asia
Low frequency Raman spectroscopy has been used to study various polymorphs and can be applied to the design of crystallization control strategy. Extending the low frequency spectral region to include the fingerprint region provides access to collective vibrations of molecules in the amorphous and crystalline states and yields valuable insight when differentiation of various forms is quintessential.
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