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|June 5, 2013
Celerion Adds Containment Room
Author(s)BioPharm International Editors
Modular containment room at Belfast facility allows studies of biologics and vaccines.
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Celerion added a containment room at the Belfast, Northern Ireland, UK facility, the company announced in a
The modular facility uses a negative-pressure processing room that houses a Biosafety Level (BSL-2) cabinet. The room enables processing of live class 2 and class 3 biological products.
Celerion’s facility in Belfast also has extensive early-stage clinical capabilities based on First-In-Human experience with both NCEs and biologics, as well as bioequivalence, biosimilars, obesity, ophthalmic, and gastro-intestinal studies.
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