Cleaning Validation for Biologics

Oct 02, 2015
Volume 2015 eBook, Issue 2
BioPharm International eBooks
Volume 28, Issue 14
 
Many pharmaceutical companies have adopted the permitted daily exposure (PDE), or acceptable daily exposure (ADE), to set cleaning validation limits. Some regulatory agencies now require its use, but some companies continue to argue against it, particularly biologics manufacturers. Critics of the approach argue that protein molecules are denatured or degraded by their cleaning processes, and that alternate approaches should be used.
 
Read this article and other articles in BioPharm International's 2015 The Future of Bioprocessing eBook.
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