During the lifetime of all products, there is a need to make changes in production methods, the impact of which must be evaluated for quality purposes as well as for submission to regulatory authorities. This is especially important for biotechnology-derived products whose characteristics are closely related to the manufacturing process. The FDA requires information to establish comparability between current products and products following manufacturing changes. Depending on the change, in vitro comparisons, animal data, clinical data, or some combination of these areas, may be necessary.
FEATURED TOPICS
鈥haracterization of changes in cell lines, process scale, formulation/presentation and the comparative data necessary to support these changes
鈥iscussion of in vitro biochemical, preclinical (pharmacokinetics, pharmacodynamics, toxicology, immunogenicity), or clinical data needed for some changes and value of these data
鈥ase studies and the data requested by regulatory authorities.
FEATURED TOPICS
鈥haracterization of changes in cell lines, process scale, formulation/presentation and the comparative data necessary to support these changes
鈥iscussion of in vitro biochemical, preclinical (pharmacokinetics, pharmacodynamics, toxicology, immunogenicity), or clinical data needed for some changes and value of these data
鈥ase studies and the data requested by regulatory authorities.
