BY MARGARET SPEED RICCI AND HANNS-CHRISTIAN MAHLER
Protein biopharmaceuticals are frequently prepared aseptically in a hospital pharmacy or manufactured in advance in a compounding facility or center, and the ready-to-administer preparations are likely subjected to a holding time before use. Aseptic preparation (or “traditional” compounding) of ready-to-administer parenteral preparations by dilution, reconstitution, or infusion preparation can be done for individual patients within a hospital pharmacy, whereas bulk production (or “nontraditional” compounding) of ready-to-administer preparations at compounding centers is considered manufacturing. Because of the scale of production and potentially significant holding times of the compounded products, general good practice (GxP) manufacturing considerations should be required.
