Cell Delivery Formulation for Stable pH and Long Suspension
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing cell wash and delivery solutions have limited shelf-life at standard temperatures, contain components of human or mammalian origin, and do not maintain stable pH and osmolarity, leading to suboptimal cell health and settling during storage and administration.
Innovation Solution
Formulations comprising energy sources, pH buffers, and stabilizing agents are developed to create cell wash and delivery solutions that maintain cell health and suspension for extended periods, ensuring stable pH and osmolarity without mammalian components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If traditional cell wash and delivery solutions are used, then cells can be washed and delivered, but the solutions have limited shelf-life at standard temperatures and contain components of human or mammalian origin
Solution Approach 1:
The patent reformulates the cell wash and delivery solutions by changing the chemical parameters - replacing mammalian components with synthetic alternatives, adjusting pH buffer systems, and modifying osmolarity composition. This allows the solutions to maintain stability and functionality at standard storage temperatures (2-8°C) while extending shelf-life to at least 24 hours, eliminating the need for ultra-cold storage
2Stability of the object's composition
If traditional cell wash and delivery solutions are used, then cells can be processed, but the pH value is not substantially stable over days, weeks or longer
Solution Approach 1:
The patent employs composite buffering systems that combine multiple pH buffer components (such as HEPES, bicarbonate, and phosphate buffers) working synergistically. This composite approach provides superior pH stability over extended storage periods (days to weeks) compared to single-buffer systems, maintaining physiological pH (7.2-7.4) throughout the storage duration
3Duration of action of stationary object
If traditional cell delivery solutions are used, then cells can be delivered, but the solutions do not maintain cells substantially in suspension through 8 hours or longer
Solution Approach 1:
The patent introduces suspending agents and viscosity modifiers as intermediary substances in the cell delivery solution. These agents (such as hydroxyethyl starch, dextran, or gelatin) act as mediators that prevent cell aggregation and settling by providing steric hindrance and increasing solution viscosity, thereby maintaining uniform cell distribution for at least 8 hours to ensure accurate dosing
4Stability of the object's composition
If traditional cell wash solutions with many components are used, then cells can be washed effectively, but the solutions do not maintain a substantially physiological osmolarity
Solution Approach 1:
The patent extracts and eliminates unnecessary components from traditional complex cell wash solutions, retaining only the essential elements needed for effective cell washing and delivery. By removing excess additives and simplifying the formulation to core components (buffer, salts, energy sources, and protective agents), the solution maintains physiological osmolarity (270-320 mOsm/kg) while reducing manufacturing complexity
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 solutions provide a stable pH and osmolarity, preventing cell settling and ensuring accurate dose assurance for up to 104 hours, maintaining cell viability and health during storage and administration.
Implementation Method 1
formulations or compositions that include one or more energy source components; one or more pH buffers; one or more salts; and one or more stabilizing agents
Implementation Method 2
The cell suspension for injection provides cells in suspension for several hours, while maintaining a sufficient level of cell health
Implementation Method 3
a substantially stable pH value over days, weeks or longer, a substantially physiological osmolarity
Data Source
AI summary
The present disclosure is directed to various compositions that include one or more energy source components; one or more pH buffers; one or more salts; and one or more stabilizing agents and one or more cell types.