Lyophilized reagents
Inventors
Butzler, Matthew A. • Reed, Jennifer L. • McFall, Sally • Agarwal, Abhishek K. • Kelso, David M. • Westberg, Tom
Assignees
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Publication Number
US-12601542-B2
Publication Date
2026-04-14
Expiration Date
Abstract
Provided herein are methods of producing lyophilized reagents with desired physical characteristics, and the lyophilized reagents produced thereby. In particular, lyophilized combinations of reagents are provided with specific physical geometries that provide optimized use in assays and devices.
Core Innovation
A circular pellet having a planar bottom and a domed top is formed from a reagent mixture by dispensing a single droplet onto a planar surface that is chilled to a temperature below a freezing temperature of the reagent mixture. The pipette tip is positioned at a non-vertical angle relative to the planar surface so that the droplet clings to the tip, and the tip angle is then adjusted to a vertical position so that the droplet falls from the tip onto the planar surface.
The single droplet freezes upon contact with the chilled planar surface, producing the pellet geometry with a planar bottom and a domed top. The forming process is described as freezing within contact with the planar surface, including embodiments in which the droplet freezes within 1 second after contacting the planar surface.
The document also describes lyophilized reagent pellets and disk-shaped forms formed by freezing a single droplet or a defined volume in or on chilled planar surfaces, planar-topped columns, or wells followed by lyophilization to yield tailored geometries for assay/device use. Example reagent concepts include PCR reagents combined with excipients such as dextran and trehalose, with described concentration ranges for dextran and trehalose, and the resulting lyophilized geometries are associated with assay performance context including PCR/qPCR.
Claims Coverage
The document contains one independent method claim directed to forming a circular pellet with a planar bottom and a domed top, comprising three main inventive steps: angled pipette alignment and dispensing a single droplet, chilled planar surface contact, and adjusting to vertical to cause droplet fall and freezing on contact.
Chilled planar surface and angled single-droplet dispensing to form a domed pellet
A method of forming a circular pellet with a planar bottom and a domed top by aligning a pipette containing a reagent mixture above a planar surface with the tip at a non-vertical angle relative to the planar surface, wherein the planar surface has been chilled to a temperature below a freezing temperature of the reagent mixture; dispensing a droplet such that the droplet clings to the tip; and adjusting the angle to a vertical position so the droplet falls onto the planar surface, such that the single droplet freezes upon contact with the planar surface.
Across the independent claim, the inventive coverage centers on the specific pellet geometry formation (circular pellet with planar bottom and domed top) achieved by freezing a single droplet on a chilled planar surface, using an angled pipette to control droplet clinging and droplet falling onto the surface.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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