Open AccessQuality assurance of biologics and conclusions to be drawn for gene therapy products
Author(s) -
Zimmermann Gerd,
Vocke Tobias,
Meager Anthony
Publication year - 1997
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/(sici)1099-1786(199709)2:3<103::aid-qaj43>3.0.co;2-4
Subject(s) - standardization , quality assurance , scope (computer science) , quality (philosophy) , risk analysis (engineering) , control (management) , class (philosophy) , quality control , engineering ethics , computer science , engineering , engineering management , medicine , management science , process management , microbiology and biotechnology , operations management , biology , artificial intelligence , epistemology , philosophy , external quality assessment , programming language , operating system
Starting with a historical outlook on the initial appearance of biological medicines in the late 19th century, the authors describe the specific features of this class of drugs and the current approaches towards their quality assurance. A brief review on currently valid strategies is given covering the specific requirements for source materials, manufacturing processes and batch release testing. Further specific features relating to licensing, standardization and control are also discussed. The authors conclude that most of the principles which have proven to be useful in the current scope of biological medicines should also be applied to gene therapy products. In addition, however, this emerging new class of products has new and unique features which create corresponding new needs in standardization and control. © 1997 John Wiley & Sons, Ltd.