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Biological Agent Integrity

Meaning

Biological agent integrity defines the state of being whole, unimpaired, and functionally active for complex therapeutic substances derived from living organisms, such as hormones, growth factors, or peptides. This integrity is a critical quality attribute, ensuring the biological agent retains its intended molecular structure and corresponding pharmacological activity within the human physiological system. Loss of integrity can lead to reduced efficacy, altered pharmacokinetics, or the formation of immunogenic degradation products.