Guidance for Industry: Stability Testing of New Biotechnological/BiologicalVeterinary Medicinal Products VICH GL17. Final Guidance

摘要

The guidance stated in the VICH harmonized tripartite guidance entitled'Stability Testing of New Veterinary Drug Substances and Medicinal Products' (GL3) applies in general to new biotechnological/biological products. However, biotechnological/biological products have distinguishing characteristics to which consideration should be given in any well-defined testing program designed to confirm their stability during the intended storage period. For such products in which the active components are typically well-characterized proteins and/or polypeptides, maintenance of molecular conformation and, hence, of biological activity, is dependent on noncovalent as well as covalent forces. The products are particularly sensitive to environmental factors such as temperature changes, oxidation, light, ionic content, and shear. To ensure maintenance of biological activity and to avoid degradation, stringent conditions for their storage are usually necessary. The evaluation of stability may necessitate complex analytical methodologies. Assays for biological activity, where applicable, should be part of the pivotal stability studies.