Pre-activated Biomolecule Conjugation for On-Demand Labeling

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Solution Overview

Problem

The current process for preparing labelled biomolecule reagents is expensive, labor-intensive, and not scalable for small-scale requests due to the need for individual synthesis and purification of each biomolecule with a detectable marker, limiting on-demand production and customer choice.

Innovation Solution

A method involving the pre-activation of biomolecules and detectable markers with reactive linkers, allowing for on-demand conjugation and purification to create customized labelled biomolecule reagents, enabling efficient and scalable production of high-quality products.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If each biomolecule is separately conjugated to a detectable label by individual synthetic protocols followed by purification, then the labelled biomolecule reagent can be prepared with high quality and specificity, but the process becomes expensive and labor intensive

Engineering Contradiction:
Improvequality and specificity of labelled biomoleculeVSAvoidcost and labor intensity
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The patent applies preliminary action by pre-conjugating biomolecules to detectable labels in advance and storing them as pre-formed components. When a customer request is received, the system simply retrieves and combines pre-formed labelled biomolecules from storage, eliminating the need for individual synthetic protocols and purification steps at the time of ordering. This resolves the contradiction by maintaining high quality through pre-validation while dramatically reducing cost and labor intensity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent segments the labelled biomolecule preparation process into separate stored components (biomolecule portions and detectable label portions) that can be independently maintained and combined. This segmentation allows each component to be optimized and stored separately, then quickly assembled when needed, reducing the complexity and cost of the overall manufacturing process while maintaining product quality.

Inventive Principle:
Principle #1Segmentation

2Productivity

If labelled biomolecule reagents are prepared and stored in advance, then customers can select from available inventory, but on-demand preparation of performance-specific probe compositions is not possible

Engineering Contradiction:
Improveavailability of pre-synthesized reagentsVSAvoidcustomization capability
Core Design Contradiction:
ProductivityVSAdaptability or versatility

Solution Approach 1:

The patent segments labelled biomolecules into separate storable components (biomolecule portions and detectable label portions) that can be independently maintained in inventory. When customization is needed, these segmented components are recombined in different configurations to create performance-specific probe compositions. This segmentation enables both rapid delivery from inventory and flexible customization on-demand.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent implements a dynamic system where pre-formed labelled biomolecule components are stored in inventory for immediate availability, but can be dynamically reconfigured and recombined based on specific customer requirements. This dynamic approach allows the system to switch between fulfilling orders from pre-prepared inventory and creating customized compositions, thereby achieving both high productivity and adaptability.

Inventive Principle:
Principle #15Dynamics

3Manufacturing precision

If individual synthetic protocols and purification steps are used for each labelled biomolecule, then high quality reagents are produced, but the lead time for synthesis and purification is excessive

Engineering Contradiction:
Improvequality of labelled biomolecule reagentVSAvoidlead time for synthesis and purification
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The patent applies preliminary action by performing the time-consuming synthesis and purification steps in advance to create pre-formed labelled biomolecule components. These components are then stored in inventory, allowing customers to receive high-quality reagents immediately without waiting for synthesis and purification. The quality is maintained through pre-validation, while the lead time is eliminated for routine orders.

Inventive Principle:
Principle #10Preliminary action

4Ease of manufacture

If a limited database of pre-synthesized labelled biomolecule reagent compositions is provided, then inventory management is simplified, but customer choice and customization options are restricted

Engineering Contradiction:
Improveinventory management simplicityVSAvoidcustomer choice
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The patent segments labelled biomolecules into separately storable biomolecule portions and detectable label portions. This segmentation allows the inventory to maintain a broad library of basic components while enabling unlimited customization through recombination. Customers can choose from diverse combinations of biomolecules and labels without requiring the system to pre-synthesize every possible combination, thereby maintaining inventory simplicity while vastly expanding customer choice.

Inventive Principle:
Principle #1Segmentation

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

This approach reduces production costs and time, enabling fast and flexible preparation of high-quality labelled biomolecule reagents tailored to specific customer requests, improving scalability and reducing lead times.

Implementation Method 1

The biomolecule is conjugated to the detectable marker by one or more covalent bonds to the backbone or a side chain of the biomolecule

Methodology Applied
Scientific EffectCovalent bonding: Chemical Bonding

Data Source

PatentUS20240102996A1Methods and Systems for Providing Labelled Biomolecules
Publication Date: 2024.03.28 BECTON DICKINSON & CO
  • US20240102996A1 patent drawing
  • US20240102996A1 patent drawing
  • US20240102996A1 patent drawing

AI summary

Aspects of the present disclosure include systems for use in preparing a labelled biomolecule reagent. Systems according to certain embodiments include an input manager for receiving a request for a labelled biomolecule reagent, a memory for storing a dataset having a plurality of labelled biomolecule reagent storage identifiers, a processing module communicatively coupled to the memory and configured to identify one or more labelled biomolecule reagent storage identifiers from the dataset that corresponds to the labelled biomolecule reagent request and an output manager for providing the one or more identified labelled biomolecule reagent storage identifiers. A reagent preparatory apparatus for preparing the labelled biomolecule reagent from an activated biomolecule and activated label is also described. Methods for communicating and receiving a labelled biomolecule reagent request and preparing the subject labelled biomolecule reagents are also provided.