Tag: ICH Q5C guidelines

Stability Testing for Biopharmaceuticals: Expert Regulatory Guide

Stability Testing for Biopharmaceuticals: Expert Regulatory Guide Stability Testing for Biopharmaceuticals: In-Depth Regulatory and Analytical Framework Introduction Biopharmaceuticals, including monoclonal antibodies, recombinant proteins, peptides, and gene therapies, represent a rapidly growing segment of the pharmaceutical market. However, due to their complex structures and sensitivity to environmental factors, stability testing for biopharmaceuticals requires specialized protocols beyond…

Stability Testing for Biopharmaceuticals, Stability Testing Types

Biologics and Specialized Stability Testing: Strategies for Lifecycle Integrity

Biologics and Specialized Stability Testing: Strategies for Lifecycle Integrity Biologics and Specialized Stability Testing: Strategies for Lifecycle Integrity Introduction Biologic products—including monoclonal antibodies, recombinant proteins, peptides, cell-based therapies, and vaccines—present unique challenges in pharmaceutical stability testing due to their molecular complexity and susceptibility to environmental stressors. Unlike small molecules, biologics are sensitive to temperature, light,…

Biologics and Specialized Stability Testing