Stabilizing Excipients for Freeze-Dried Live Microbial Cells

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Solution Overview

Problem

Existing formulations for live microbial cells lack effective long-term stabilization, leading to significant viability loss during storage and processing, which hampers their use in various applications.

Innovation Solution

Development of compositions comprising specific stabilizing excipients such as enzymatic digest of soy, palatinose hydrate, and other compounds for microbial cells like Escherichia coli, Saccharomyces boulardii, Lactobacillus plantarum, and Ensifer meliloti, which enhance cell viability during freeze-drying and storage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional formulations are used for live microbial cells, then manufacturing and processing can proceed, but significant viability loss occurs during storage and processing

Engineering Contradiction:
Improvemicrobial cell viabilityVSAvoidstorage duration
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent introduces stabilizing excipients (intermediary substances) that mediate between the microbial cells and harsh storage conditions. These excipients form protective matrices around the cells during freeze-drying, preventing direct exposure to damaging environments and maintaining viability throughout storage duration.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent modifies the physical and chemical parameters of the storage environment by controlling freeze-drying conditions (temperature, pressure, humidity) and selecting excipients with specific properties. These parameter changes create an optimized stabilization environment that preserves microbial viability during long-term storage.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If freeze-drying process is applied to stabilize microbial cells, then long-term storage is enabled, but cell viability may be reduced during the drying process

Engineering Contradiction:
Improveformulation stabilityVSAvoidmicrobial cell viability
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent applies beforehand cushioning by incorporating stabilizing excipients prior to freeze-drying that cushion and protect microbial cells from the mechanical and osmotic stresses of the drying process. These excipients are selected and formulated to specifically counteract damage mechanisms during freeze-drying, ensuring both stability and viability are maintained.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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

The proposed compositions significantly improve the long-term stability and viability of microbial cells, allowing them to withstand harsh conditions and maintain functionality for extended periods.

Implementation Method 1

enhance cell viability during freeze-drying and storage

Methodology Applied
Scientific EffectFreeze-drying: Freeze Drying

Data Source

PatentUS20250288624A1Long-term stabilization, formulation and tableting of live microbial cells
Publication Date: 2025.09.18 MASSACHUSETTS INST OF TECH
  • US20250288624A1 patent drawing
  • US20250288624A1 patent drawing
  • US20250288624A1 patent drawing

AI summary

Provided herein are compositions comprising Escherichia coli (E. coli), Saccharomyces boulardii (S. boulardii), Lactobacillus plantarum (L. plantarum), and/or Ensifer meliloti (E. meliloti) and a first stabilizing excipient. Also provided herein are methods of delivering E. coli, S. boulardii, L. plantarum, and/or E. meliloti to a subject in need thereof, methods of inducing bacterial growth in a subject or in a cell, tissue, or biological sample, and methods of inhibiting an enteric pathogen in a subject or in a cell, tissue, or biological sample. Further provided herein are methods of treating dysbiosis in a subject in need thereof.