Do Stringent Quality Guidelines Drive BioProcess Design?
Do Stringent Quality Guidelines Drive BioProcess Design? Wednesday December 10, 2008#spacer{clear:left}#abc #sidebar{margin-top:1.5em}zSB(3,3) The biopharmaceutical industry is, by some definitions, the industry surrounding bioprocessing and the discovery, development and production of small-molecule drugs. These drugs are derived from living organisms as opposed to being chemically synthesized using traditional methods of pharmaceutical companies. Examples of these drugs are proteins such as antigens used for vaccines, or nucleotide oligomers such as the “primer” vaccine for AIDs developed by GeoVax. In March 2008, bioprocessing was said, by jounalists for BioProcess International, to be embarking on a “new era”, driven by new “high-level ICH and FDA quality guidelines”. The authors also proposed that “the emerging field of systems biology may hav
