Straight-Walled Vial for Intact Lyophilized Cake Removal

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Solution Overview

Problem

Existing lyophilization vials have a necked design, making it impossible to remove the lyophilized cake in an intact form, which limits the therapeutic options for biopharmaceuticals like vaccines.

Innovation Solution

A straight-walled vial system is used, where a blend of antigen and stabilizer is lyophilized, and the cake is removed without cracking or breaking by utilizing a solid lyophilized vaccine composition within the vial, with optional annealing at −25° C. and the use of bulking agents like mannitol.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a necked vial design is used for lyophilization, then the vial structure is conventional and easy to manufacture, but the lyophilized cake cannot be removed in an intact form

Engineering Contradiction:

Improveremovability of lyophilized cakeVSAvoidvial structure design

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The patent inverts the conventional necked vial design by using a straight-walled vial without a neck. This inversion allows the lyophilized cake to be removed intact from the vial, as the straight walls provide sufficient clearance for the cake to be extracted without breaking, thereby solving the removability issue while maintaining manufacturing simplicity

Inventive Principle:

Principle #13The other way round (Inversion)

2Manufacturing precision

If the lyophilized cake is removed from a necked vial, then the cake breaks or cracks, but using a straight-walled vial allows intact removal

Engineering Contradiction:

Improveintegrity of lyophilized cakeVSAvoidvial geometry

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

By inverting the conventional necked vial geometry to a straight-walled design, the patent enables intact cake removal. The straight walls eliminate the geometric constraint that causes cake breakage in necked vials, allowing the cake to be extracted without cracking while the vial structure remains simple to manufacture

Inventive Principle:

Principle #13The other way round (Inversion)

3Adaptability or versatility

If a straight-walled vial is used, then the lyophilized cake can be removed intact, but the vial design deviates from conventional standards

Engineering Contradiction:

Improvetherapeutic options for biopharmaceuticalVSAvoidvial design standard

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent inverts the conventional vial design to enable new therapeutic applications. By using a straight-walled vial instead of a necked vial, the system allows for intact cake removal and subsequent oral or injectable administration routes, expanding therapeutic versatility while the vial design remains fundamentally simple

Inventive Principle:

Principle #13The other way round (Inversion)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables the removal of the lyophilized cake in a substantially intact form with minimal loss of viability and residue, enhancing the presentation and administration of biopharmaceuticals as oral or injectable forms.

Implementation Method 1

lyophilization is a commonly-employed freeze-drying process which yields a stable dried or powdered product, often a lyophilized cake

Methodology Applied

Scientific EffectLyophilization (freeze-drying): Freeze Drying

Implementation Method 2

lyophilization is a commonly-employed freeze-drying process

Methodology Applied

Scientific EffectSublimation: Sublimation

Implementation Method 3

the method comprises adding mannitol to the blend of antigen and stabilizer and further comprises annealing the blend at −25° C. prior to removing the solid lyophilized vaccine composition

Methodology Applied

Scientific EffectAnnealing: Annealing

Data Source

PatentUS20220409484A1Lyophilized cake in straight-walled vial

Publication Date: 2022.12.29 ELANCO US INC

AI summary

A system including a vial and methods of its use to provide a lyophilized cake removable from the vial without cracking or breaking.