Biologic Drug Integrity After Multiple Freeze-Thaw Events
Biologic Drug Integrity After Multiple Freeze-Thaw Events Biologic Drug Integrity After Multiple Freeze-Thaw Events: Strategies for Risk Mitigation and Quality Assurance Biologic drugs—such as monoclonal antibodies (mAbs), peptides, vaccines, and mRNA-based therapies—are particularly sensitive to environmental conditions, including temperature fluctuations. Repeated freeze-thaw events can lead to protein unfolding, aggregation, phase separation, and other structural instabilities…
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