✦ LIBER ✦

Quality assurance of biologics and conclusions to be drawn for gene therapy products

✍ Scribed by Gerd Zimmermann; Tobias Vocke; Anthony Meager

Publisher: John Wiley and Sons
Year: 1997
Tongue: English
Weight: 198 KB
Volume: 2
Category: Article
ISSN: 1087-8378
DOI: 10.1002/(sici)1099-1786(199709)2:3<103::aid-qaj43>3.0.co;2-4

No coin nor oath required. For personal study only.

✦ Synopsis

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.

📜 SIMILAR VOLUMES

Recommendations for successful quality a

Recommendations for successful quality assurance of production of bulk drug substances for non-viral gene therapy

✍ Wolfgang Kuhne; Konrad Zöllner 📂 Article 📅 1997 🏛 John Wiley and Sons 🌐 English ⚖ 128 KB

The quality assurance concept for GMP production of non-viral bulk drug substance for use in gene therapy is briefly summarised in the following paper. The term 'non-viral gene therapy product' is generally used for therapeutical plasmid DNA. Plasmid DNA is regarded as a 'biologic'. Without addition

What are some of the best organisms for

What are some of the best organisms for developmental genetics? How can the study of genetic interactions help us to understand the function of complex macromolecular assemblies? How can a single mutation be used as a probe to identify other genes that are involved in the production of interacting gene products?

📂 Article 📅 1989 🏛 John Wiley and Sons 🌐 English ⚖ 114 KB 👁 1 views

## Section IV. What are some of the best organisms for developmental genetics? How can the study of genetic interactions help us to understand the function of complex macromolecular assemblies? How can a single mutation be used as a probe to identify other genes that are involved in the producti