aggregation in biologics – StabilityStudies.in

Understanding the Stability of Biopharmaceuticals in Drug Development

Understanding the Stability of Biopharmaceuticals in Drug Development Comprehensive Insights into Biopharmaceutical Stability for Drug Development Introduction Biopharmaceutical stability is a cornerstone of modern drug development, especially for protein-based therapeutics, monoclonal antibodies (mAbs), peptides, and recombinant DNA products. Unlike small-molecule drugs, biopharmaceuticals are highly sensitive to environmental conditions and prone to physical and chemical degradation….

Biopharmaceutical Stability

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