Chapter 24: Considerations and Challenges When Filling High-Concentration Monoclonal Antibody Formulations into Prefilled Syringes
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Prefilled syringes are a commonly used delivery system for subcutaneous and intramuscular administration of parenteral drugs. Due to the unique attributes of the prefilled syringe delivery system, filling of prefilled syringes can present challenges not typically observed when filling other parenteral primary containers (i.e., vials). These challenges include coordination of the filling nozzle diving motion with pump speed, tight requirements for fill weight and plunger stopper position, and higher potential risk of clogging of the filling nozzle when filling high-concentration monoclonal antibody formulations. This chapter will provide an in-depth overview of these different challenges as well as examples of how to utilize a bench-top filling setup to optimize the design of the filling process.
KeywordsPrefilled syringe High-concentration monoclonal antibody formulations Process design Process optimization Drug product manufacturing Peristaltic pump Filling nozzle
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