One-Part Clinical Media for Stable Cell Storage and Transport
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Solution Overview
Problem
Current clinical media for cell and tissue storage and transport support viability and function only for short periods, often leading to significant cell loss and precipitation issues due to bicarbonate anion use, and cannot withstand heat sterilization, necessitating two-part solutions with mixing risks and short shelf life.
Innovation Solution
A one-part clinical solution is developed that uses acetate or citrate buffers, divalent cations like calcium and magnesium, and glucose to maintain physiological pH and osmolarity, avoiding bicarbonate-related precipitation and supporting cell viability for extended periods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If bicarbonate anions are used as buffering agents in clinical media, then the media can maintain physiological pH, but carbonate precipitation occurs rapidly during heat sterilization and over time at ambient storage conditions
Solution Approach 1:
The patent changes the buffering agent from bicarbonate to HEPES (a zwitterionic organic buffer), fundamentally altering the chemical parameters of the solution to eliminate precipitation while maintaining pH stability. This parameter change allows the solution to remain stable during both heat sterilization and ambient storage without forming carbonate precipitates.
Solution Approach 2:
The patent accepts that HEPES-based solutions have a limited shelf life (shorter than traditional bicarbonate solutions) but eliminates the harmful precipitation effect. The solution is designed for single-use or limited-use scenarios where the benefits of no precipitation outweigh the shorter storage duration.
2Ease of operation
If bicarbonate-based clinical media are stored at ambient temperature, then convenience is improved, but significant cell loss and precipitation occur over time
Solution Approach 1:
By changing from bicarbonate to HEPES buffering, the patent enables ambient temperature storage without the precipitation and cell loss problems that plague bicarbonate-based media. The HEPES buffer maintains pH stability at room temperature, allowing convenient ambient storage while preserving cell viability.
3Object-generated harmful factors
If two-part solutions are used to prevent precipitation, then precipitation is avoided, but manufacturing complexity and mixing errors increase
Solution Approach 1:
The patent merges calcium and magnesium salts directly into the HEPES-based buffering solution, creating a stable one-part formulation. The HEPES buffer prevents precipitation of these divalent cations, allowing them to be combined in a single solution without requiring separate storage and mixing of multiple components.
Solution Approach 2:
The patent creates a simple one-part solution that is stable enough for single-use applications. While the shelf life is limited compared to traditional solutions, the simplicity of the one-part formulation eliminates manufacturing and usage complexity, making it ideal for disposable clinical applications.
4Duration of action of stationary object
If current clinical media are used for extended storage, then storage duration is increased, but cell viability and function are significantly lost
Solution Approach 1:
By using HEPES buffer instead of bicarbonate and optimizing the composition of salts and nutrients, the patent creates a media formulation that maintains cell viability during extended storage. The HEPES buffer provides stable pH control without precipitation, and the optimized nutrient composition supports cell survival and function over longer periods.
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 solution provides prolonged shelf life and viability support for cells, allowing storage and transport of sensitive cells for up to 144 hours without precipitation, enabling central formulation and administration without mixing errors.
Implementation Method 1
uses acetate or citrate buffers, divalent cations like calcium and magnesium, and glucose to maintain physiological pH and osmolarity
Implementation Method 2
divalent cations like calcium and magnesium, and glucose to maintain physiological pH and osmolarity
Data Source
AI summary
Some aspects of this disclosure provide clinical media that support viability, re-plating efficiency, and repopulation capacity of cells and tissues during storage for up to 48 hours or longer. The clinical media provided herein are also useful for clinical irrigation. Cell or tissue preparations comprising a cell population or tissue and a clinical medium as provided herein are also provided, as are methods for generating such preparations. Methods for using the clinical media and cell and tissue preparations provided herein, for example, for administering an effective amount of cells or tissue to a subject in need thereof, are also disclosed.