Charles River Laboratories International, Inc. announced an important milestone in their strategic collaboration to manufacture CASGEVY™ (exagamglogene autotemcel [exa-cel]). CASGEVY is approved in some countries for certain eligible patients.
The news follows Charles River’s Memphis center of excellence passing back-to-back audits from both the U.S. Food and Drug Administration (FDA) and the Health Products Regulatory Authority (HPRA), on behalf of the European Medicines Agency (EMA). The Memphis facility was the first North American contract development and manufacturing organization (CDMO) to be approved by the EMA to commercially manufacture an allogeneic cell therapy drug product.
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