FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
|Articles|October 2, 2015
- BioPharm International-10-15-2015
- Volume 2015 eBook
- Issue 2
Cleaning Validation for Biologics
Author(s)Andrew Walsh
Can alternative approaches to the permitted/acceptable daily exposure be justified?
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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
eBook.
Articles in this issue
about 11 years ago
Fluctuating Capacity and Demand Conditions in Biomanufacturingabout 11 years ago
Automation of Single-Use Systemsabout 11 years ago
Are Biopharma Patents Poised on the Post-Grant Chopping Block?about 11 years ago
Raising the Bar for Biopharma TrainingAdvertisement
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