Cellular therapy site-preparedness: Inpatient pharmacy implementation at a large academic medical center.

Background: With the recent Food & Drug Administration (FDA) approval of cellular therapy that requires product manipulation prior to administration in combination with a short stability window, the need was identified for local dose preparation within the pharmacy rather than the off-site stem cell processing laboratory. This approval gave rise to assessment of regulatory standards surrounding cellular therapy, evaluation and revision of current standard operating procedures and policies with formal process validation, assessment of occupational exposure mitigation and safety considerations, and development of staff training and education.

Objective: To describe and provide insight into the stepwise process of FACT validation and onboarding of commercially available cellular therapy products that require sterile compounding manipulation within a pharmacy prior to administration.

Treatment of hemorrhagic acute disseminated encephalomyelitis with cyclophosphamide.

Purpose: Improvements in hemorrhagic and clinical symptoms in a patient with hemorrhagic acute disseminated encephalomyelitis (ADEM) treated with i.v. cyclophosphamide are reported.