Vice President, Analytical Biochemistry
MedImmune, Gaithersburg, MD
"Analytical Control Strategy for Biologics"
The purpose of the analytical control strategy is to assure that materials are manufactured within control and that product is safe and effective throughout shelf-life. The control strategy should be developed with emphasis on sound scientific principles and with attention to international and regional guidelines. Those guidelines while not always explicit are clear on the fundamental principle of the control strategy – assurance of product quality. The analytical control strategy is based upon both process and product attributes. Some attributes are critical to quality while others signal process consistency. Still others may be reported and used to gain continuous knowledge about the process. During development the sponsor gathers information on potential quality attributes and uses this to formulate the analytical control strategy. Key to a rational analytical control strategy is the acknowledgement of risk. Identification of critical quality attributes and justification of acceptance criteria are subject to risks associated with both patient and manufacturing impact. This talk will describe the process of identifying critical quality attributes and developing meaningful acceptance criteria.