Portable API Formulation Modules for On-Demand Sterile Dosing
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Solution Overview
Problem
Traditional pharmaceutical manufacturing systems require large-scale facilities, long timescales, and extensive reconfiguration for producing different drug products, leading to inefficiencies and high inventory costs.
Innovation Solution
A modular and reconfigurable system comprising a consolette and fluidic path with pumps, valves, and a controller to form fluidic channels, enabling on-demand production of liquid formulations of active pharmaceutical ingredients (APIs) with precise control over fluid flow and mixing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional large-scale batch processing facilities are used, then manufacturing capacity is sufficient, but production time increases and facility reconfiguration becomes complex
Solution Approach 1:
The system divides the pharmaceutical manufacturing process into modular functional units (mixing module, filtration module, filling module, etc.) that can operate independently and be reconfigured. Each module handles a specific step, allowing parallel processing and eliminating the need for complete facility reconfiguration when switching between different drug products.
Solution Approach 2:
The system employs dynamic reconfiguration capabilities where fluidic paths, connections, and module arrangements can be changed on-demand. The modular design with standardized interfaces enables rapid assembly and disassembly of different process configurations, transforming the static facility into a dynamically adaptable system that optimizes production time for different formulations.
2Reliability
If dedicated facilities are used for specific drug products, then manufacturing quality is controlled, but adaptability to produce different products decreases
Solution Approach 1:
The system implements universal modular units with standardized interfaces and protocols that can perform multiple functions. Each module (mixing, filtration, filling) is designed to handle different materials and formulations while maintaining quality standards, allowing the same facility to reliably produce multiple different drug products without sacrificing manufacturing quality.
Solution Approach 2:
The system maintains quality control through controlled parameter changes rather than physical facility changes. By adjusting process parameters (flow rates, temperatures, pressures, mixing speeds) within each modular unit rather than reconfiguring the entire facility, the system achieves both adaptability for different products and reliability for quality control.
3Manufacturing precision
If multi-step chemical synthesis and purification processes are used, then product purity is achieved, but device complexity and facility requirements increase
Solution Approach 1:
The system extracts and isolates the essential formulation steps (mixing, filtration, filling) from the complete pharmaceutical manufacturing process. By focusing only on the formulation stage rather than full synthesis and purification, the system achieves sufficient formulation accuracy while dramatically reducing device complexity and facility requirements compared to complete multi-step processes.
4Quantity of substance
If batch processing at multiple locations is used, then large inventories can be maintained, but production efficiency and inventory costs decrease
Solution Approach 1:
The system enables continuous on-demand production of pharmaceutical formulations, eliminating the batch processing interruptions and inventory holding requirements. The modular units can operate continuously, producing formulations as needed, which maintains sufficient supply capacity while improving production efficiency and eliminating the need for large inventories at multiple locations.
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 rapid production of multiple drug products in a GMP and FDA-compliant manner, reducing production times and facility requirements, and allowing for flexible switching between formulations.
Implementation Method 1
a pump operable to flow fluid through the fluidic path
Implementation Method 2
a filter operable to filter fluid pumped through one or more channel of the fluidic path
Implementation Method 3
a mixing unit operable to mix the ingredients of the liquid formulation
Data Source
AI summary
This disclosure provides systems and methods for the production of formulations of active pharmaceutical ingredients (APIs). In some embodiments, the disclosure provides an automated medicine formulation system comprising a portable and self-contained API formulating apparatus where the API and excipients are formulated to make a drug product meeting drug quality and safety specifications. The automated formulation system produces liquid formulations including, for example, injectable and intravenous medicines. The systems are capable of producing a plurality of individual sterile injectable doses of drug comprising a specific API and excipient(s), which can be formulated on demand in a GMP and FDA acceptable manner.