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Delicate biologics can destabilize if frozen or heated improperly, leading to unsafe and unusable final merchandise. They're also sensitive to various interactions within the lyophilization process which may trigger the proteins to unfold, resulting in loss of therapeutic effectiveness for that patient2. Collapse The point at which the merchandise
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In which the manufacturer of a nonsterile API both intends or promises that it is well suited for use in even more processing to provide a sterile drug (medicinal) product or service, h2o Utilized in the final isolation and purification steps needs to be monitored and controlled for complete microbial counts, objectionable organisms, and endotoxins
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