FDA Guidance for Industry: Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability
Titel:
FDA Guidance for Industry: Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability
Internet:
Herkunft/Verlag:
Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073471.pdf
Dokumentenart:
FDA Guidance for Industry
Inhalt:
Diese Guideline definiert Standards für die Derivatisierung humaner und tierischer Zellinien und Mikroorganismen für die Herstellung biotechnologischer/biologischer Produkte sowie für die Herstellung und Charakterisierung von Zellbänken.