Скачать или смотреть Critical Quality Attributes in Nanomedicine: CMC Strategies, Analytics, and Regulatory Insight

Critical Quality Attributes, or CQAs, are a cornerstone of nanomedicine CMC and a key focus area for regulators.

Unlike small molecule drugs, nanomedicines are complex systems whose safety, efficacy, and quality depend on multiple interdependent attributes. Particle size, size distribution, surface charge, morphology, composition, and stability are all considered critical quality attributes that must be understood and controlled throughout development.

In this video, we explain:
• What CQAs are and why they are essential in nanomedicine
• How particle size and size distribution influence biodistribution and clearance
• Why surface charge and surface chemistry impact stability and in vivo behavior
• The role of morphology and composition as CQAs
• How manufacturing scale-up affects critical quality attributes
• Why orthogonal analytical methods are required for CQA control
• What regulators expect regarding CQA understanding, control strategies, and lifecycle management

Early identification and robust control of CQAs reduce late-stage failures, support successful scale-up, and increase regulatory confidence.

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#Biopharma
#FDA
#EMA