Cleaning Validation for Biologics
Can alternative approaches to the permitted/acceptable daily exposure be justified?
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 BioprocessingeBook.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
