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Abstract
An ongoing monitoring program is an essential component of operating a Good Manufacturing Practice (GMP) facility. To support manufacture of clinical grade viral gene transfer vectors, the Belfer Gene Therapy Core Facility has a Class 100,000 GMP facility with three production laboratories, in which all open operations of production are conducted in Class 100 biological safety cabinets. The routine monitoring program measures viable and non-viable particles weekly and temporal trending is assessed to identify emerging problems.
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