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. Appropriate physicochemical, biochemical, and immunochemical methods for the analysis of the molecular entity and the quantitative detection of degradation products should also be part of the stability program whenever purity and molecular characteristics of the product permit use of these methodologies.
With these concerns in mind, the applicant should develop the proper supporting stability data for a new biotechnological/biological product and consider many external conditions that can affect the product's potency, purity, and quality. Primary data to support a requested storage period for either drug substance or drug product should be based on long term, real time, real condition stability studies. Thus, the development of a proper long term stability program becomes critical to the successful development of a commercial product. The purpose of this document is to give guidance to applicants regarding the type of stability studies that should be provided in support of marketing applications. It is understood that during the review and evaluation process, continuing updates of initial stability data may occur.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.