FDA Guidance for Industry: Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Titel:
FDA Guidance for Industry: Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
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/ucm073459.pdf
Dokumentenart:
FDA Guideline for Industry
Inhalt:
Diese Guideline behandelt Aspekte, die wichtig sind für die Strukturermittlung des Expressionskonstrukts, aus dem rekombinante Proteine hergestellt werden.