Transportation of mAb Dosing Solution in Intravenous Bag: Impact of Manual, Vehicle, and Pneumatic Tube System Transportation Methods on Product Quality

Monoclonal antibody (mAb) products for intravenous (IV) administration generally require aseptic compounding with a commercial diluent within a pharmacy. The prepared dosing solution in the IV bag may be transported to the dosing location via manual, vehicular, pneumatic tube system (PTS), or a comb...

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Veröffentlicht in:Molecular pharmaceutics 2023-12, Vol.20 (12), p.6474-6491
Hauptverfasser: Desai, Kashappa Goud, Colandene, James D., Crotts, George, Sofa, Cait, Wang, Ning, Blockus, Brendan, Mandal, Bivash, Wittig, Katie, Shukla, Asha
Format: Artikel
Sprache:eng
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Zusammenfassung:Monoclonal antibody (mAb) products for intravenous (IV) administration generally require aseptic compounding with a commercial diluent within a pharmacy. The prepared dosing solution in the IV bag may be transported to the dosing location via manual, vehicular, pneumatic tube system (PTS), or a combination of these methods. In this study, the type and level of physical stresses associated with these three methods and their product quality impact for relatively sensitive and stable mAbs were assessed. Vibration was found to be the main stress associated with manual and vehicle transportation methods, although this was at a relatively low level (
ISSN:1543-8384
1543-8392
DOI:10.1021/acs.molpharmaceut.3c00859