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Chapter 24: Considerations and Challenges When Filling High-Concentration Monoclonal Antibody Formulations into Prefilled Syringes

  • Wendy ShieuEmail author
  • Yuh-Fun Maa
Chapter
  • 88 Downloads
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)

Abstract

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.

Keywords

Prefilled syringe High-concentration monoclonal antibody formulations Process design Process optimization Drug product manufacturing Peristaltic pump Filling nozzle 

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Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  1. 1.Pharmaceutical Processing and Technology DevelopmentGenentech, a Member of the Roche GroupSouth San FranciscoUSA

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