Tag: cold chain validation

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

Freeze-Thaw and Thermal Cycling Studies in Pharma: Expert Overview

Freeze-Thaw and Thermal Cycling Studies in Pharma: Expert Overview Freeze-Thaw and Thermal Cycling Studies in Pharmaceutical Stability Testing Introduction Pharmaceutical products are frequently subjected to varying temperature conditions during manufacturing, transportation, storage, and end-use. Among these variations, freeze-thaw and thermal cycling pose significant risks to product integrity, especially for biologics, injectables, and protein-based formulations. Conducting…

Freeze-Thaw and Thermal Cycling Studies, 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