Stability Testing for Biopharmaceuticals: Expert Regulatory Guide
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 those used for small-molecule drugs. Proper stability assessments are essential for ensuring product safety, efficacy, and compliance with global regulatory expectations.
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