Developing a Robust Manufacturing Process for Pre-filled Syringe Biologics: Challenges & Mitigations
Scendea Authors:
Dr Asha Kattige, Erik Doevendans
Chime Biologics Authors:
Jack Zheng, Bingming He, Peter Liu, Zack Zheng
A prefilled syringe (PFS) is a disposable syringe that comes preloaded with a specific dose of medication, ready for injection. This design simplifies the process of administering injectable drugs, as it eliminates the need to draw medication from a vial into a syringe before use.
The syringe barrel is either made from Type 1 borosilicate glass or a plastic such as polypropylene, cyclic olefin polymer or cyclic olefin copolymers. Plunger and tip cap are made of (surface coated) elastomeric materials. Syringe barrels and plungers are typically coated with an agent (e.g. silicone oil) to facilitate plunger movement. Plunger movement is accomplished by an attached piston rod (typically plastic)…