Shelf Life Challenges in Freeze-Dried and Liquid Biologic Drugs
Biologic drugs, whether in liquid or freeze-dried (lyophilized) form, present unique shelf life challenges due to their inherent structural complexity and sensitivity to environmental conditions. Proteins, peptides, and monoclonal antibodies (mAbs) degrade through mechanisms such as aggregation, oxidation, deamidation, and hydrolysis. This tutorial provides pharmaceutical professionals with insights into the common shelf life risks associated…
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