Open AccessDNA Drugs – Production and Quality Assurance
Author(s) -
Schleef M.,
Voß C.,
Schmidt T.
Publication year - 2002
Publication title -
engineering in life sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.547
H-Index - 57
eISSN - 1618-2863
pISSN - 1618-0240
DOI - 10.1002/1618-2863(200206)2:6<157::aid-elsc157>3.0.co;2-j
Subject(s) - quality assurance , good manufacturing practice , dna vaccination , dna , vaccination , microbiology and biotechnology , quality (philosophy) , process (computing) , process management , business , risk analysis (engineering) , medicine , computer science , biology , virology , genetics , regulatory affairs , pathology , philosophy , external quality assessment , epistemology , plasmid , operating system
The development of innovative therapy forms as, e.g., cell and gene therapy or vaccination with DNA, has generated new challenges in process development and quality assurance for the pharmaceutical manufacturing of DNA drugs. Vaccination with DNA has shown first clinical success in human and veterinary medicine. This study summarizes the mode of action of DNA vaccines and focuses on the relevant aspects of manufacturing such APIs (active pharmaceutical ingredients), especially with respect to quality assurance.