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US 2023/0414800 A1Published application
Systems and methods for producing sterile injection devices
AssigneeCoherus Biosciences, Inc.
InventorsWendy SHIEU, Gerald LLORACH
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Abstract
The present disclosure provides novel processes for providing sterile, pre-filled syringes or injection devices for pharmaceutical compositions, including protein and biopharmaceutical formulations. In some examples, secondary packaging is performed in an aseptic environment, which removes the need for any terminal sterilization method. In some examples, the aseptic packaging method results in a sterile injection device suitable for use in ophthalmic injections.
Claims21
A method for providing an aseptically-packaged sterile, pre-filled injection device, comprising:
- introducing an injection device comprising injection device components into an aseptic environment;
- introducing a sterile ophthalmic pharmaceutical composition into the aseptic environment or sterilizing an ophthalmic pharmaceutical composition in the aseptic environment;
- filling a body of the injection device with the sterile ophthalmic pharmaceutical composition in the aseptic environment to produce a sterile filled injection device body;
- stoppering the sterile filled injection device body in the aseptic environment to form a sterile stoppered pre-filled injection device;
- and
- packaging and sealing the sterile stoppered pre-filled injection device into packaging in the aseptic environment to produce the aseptically packaged sterile pre-filled injection device.
3 more elements
Dependencies are inferred from the claim text.