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Delicate biologics can destabilize if frozen or heated improperly, leading to unsafe and unusable final item. Also they are delicate to various interactions throughout the lyophilization process which may lead to the proteins to unfold, leading to lack of therapeutic effectiveness for the patient2.&

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10. Decide if information relating to nonconforming product and high-quality challenges and corrective and preventive actions has become thoroughly disseminated, which include dissemination for management review. Continual Enhancement: A philosophy and methodology focused on the continued improve