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US 12,440,622 B2Granted
Devices and methods for overfilling drug containers
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsDaniel B. Dix, Douglas Kamen, Kenneth Graham
Life of this patent
Estimating the term…
Abstract
Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.
Claims20
A drug product, comprising:
- a primary packaging component having a nominal volume, wherein the primary packaging component includes a body and a flange;
- a volume of formulated drug substance in the primary packaging component, wherein the volume of formulated drug substance is greater than the nominal volume, and wherein the volume of formulated drug substance is within an interior of the body of the primary packaging component;
- a stopper, wherein the stopper is sized and configured to fit snugly within a wall of the interior of the body;
- and
- a plunger rod connected to the stopper,
- wherein the stopper is positioned within the primary packaging component at a stopper position that is at a distance distal to the flange that restricts the plunger rod from tilting to deform the stopper to an extent that compromises a seal formed by the stopper.
3 more elements
Dependencies are inferred from the claim text.