Syringe Pump Infusion - How to Overcome Clinical Administration Challenges for Fusion Proteins and Bispecific Antibodies

摘要

Many new biological drugs pose technical challenges to clinical IV administration by e.g. having wide dose ranges to be covered by one drug product concentration in early phases, Maximum Anticipated Biological Effect Level (MABEL) dosing, chemical and physical instabilities (e.g. low recovery) upon interaction with diluents and administration contact materials, or the drug is causing concentration dependent infusion site reactions.