Philosophy and goals of validation for biotech products and the relevance of scale.
A model for validation of viral clearances in Biopharmaceutical processes is developed from an analysis of validation of terminal sterilization processes. The model develops the role for small-scale experiments in the validation of large-scale production processes. The steps for process validation are: identify or discover the basic general physical, chemical, or biological laws governing the process; identify the critical process control parameters for the specific application under investigation; and demonstrate the ability of the production equipment to maintain critical parameters with specified limits. For concurrent validation, this final step is seen as equivalent to demonstrating that a scaled-down model experiment is an appropriate representation of the production process.
Hageman
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Biogen Inc., Cambridge Center, MA 02142.
D001688:Biological Products / Q000302:isolation & purification / Q000592:standards*; D001709:Biotechnology / Q000706:statistics & numerical data*; D004340:Drug Contamination; D015203:Reproducibility of Results; D012449:Safety
D001688:Biological Products