biopharmaceutical stability testing

Stability Protocol Design for Monoclonal Antibodies

Stability Protocol Design for Monoclonal Antibodies Designing Stability Protocols for Monoclonal Antibodies: Regulatory and Scientific Best Practices Monoclonal antibodies (mAbs) are among the most complex and sensitive drug products in the biopharmaceutical landscape. Their large molecular structure, post-translational modifications, and susceptibility to environmental stress make stability protocol design a critical component of product development and…

Stability Testing for Biopharmaceuticals, Stability Testing Types

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