Freeze-Thaw Tolerance Testing for Biologic APIs
Freeze-Thaw Tolerance Testing for Biologic APIs Comprehensive Guide to Freeze-Thaw Tolerance Testing for Biologic APIs Biologic active pharmaceutical ingredients (APIs)—including monoclonal antibodies, recombinant proteins, peptides, and biosimilars—are inherently sensitive to environmental stresses. Among the most impactful of these is freeze-thaw cycling, which simulates temperature excursions during storage, shipping, and handling. Understanding how to assess freeze-thaw…
Read More “Freeze-Thaw Tolerance Testing for Biologic APIs” »