Shipping of therapeutic somatic cell products.

ABSTRACT:

Background aims

Shipment of therapeutic somatic cells between a current good manufacturing practice (cGMP) facility and a clinic or between different cGMP facilities requires validated standard operating procedures (SOP). Under National Heart Lung & Blood Institute (NHLBI) sponsorship, the Production Assistance for Cellular Therapies (PACT) group conducted a validation study for the shipping SOP it has created, including shipments of cryopreserved somatic cells, fresh peripheral blood specimens and apheresis products.

Methods

Comparisons of pre- and post-shipped cells and cell products at the three participating facilities included measurements of viability, phenotypic profiles and cellular functions. The data were analyzed at the University of Pittsburgh Biostatistics Facil

SUBMITTER: Whiteside TL 

PROVIDER: S-EPMC7982143 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature