Automated Buffer Transfer Using Single-Use Bags for Antibody Manufacturing
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Solution Overview
Problem
The conventional buffer preparation process for antibody pharmaceutical manufacturing is labor-intensive, time-consuming, and poses health risks due to manual handling of chemicals, requiring a large facility area and involving high initial costs and contamination risks.
Innovation Solution
A buffer preparation and transfer system that automates the preparation and transfer of buffer solutions using a control unit, adjusting valves to control concentration and composition, utilizing single-use disposable bags to minimize corrosion and reduce labor, and optimizing facility space.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If manual buffer preparation is used, then facility area and initial costs are reduced, but labor input and process time increase significantly
Solution Approach 1:
The patent uses disposable single-use buffer preparation bags instead of permanent stainless steel systems. These single-use bags eliminate the need for expensive stainless steel tanks and complex cleaning/sterilization infrastructure, significantly reducing facility area requirements while enabling automated buffer preparation that improves productivity.
Solution Approach 2:
The system enables self-service automated buffer preparation where the control unit automatically controls pumps, valves, and mixing processes without manual intervention. The single-use bags are pre-configured with necessary components, allowing the system to prepare buffers autonomously, reducing both labor input and facility complexity.
2Productivity
If automated buffer preparation system is used, then labor input and process time are reduced, but device complexity increases
Solution Approach 1:
The patent combines multiple buffer preparation functions (mixing, filtering, storage) into a single integrated single-use bag system. This merging of functions reduces the number of separate devices and connections needed, thereby reducing overall system complexity while maintaining automated preparation capabilities that improve productivity.
Solution Approach 2:
The single-use buffer preparation bags are designed as universal components that can handle multiple buffer types and preparation scenarios. This multi-functionality eliminates the need for separate specialized equipment for different buffer preparations, reducing device complexity while enabling efficient automated operation across various applications.
3Ease of operation
If stainless steel process system is used, then automation and operation cost are improved, but initial installation cost and contamination risk increase
Solution Approach 1:
The patent replaces expensive stainless steel process systems with disposable single-use bags that can be automatically controlled. While stainless steel systems offer automation capability, the single-use bags achieve comparable automation at much lower initial installation cost by eliminating expensive hardware infrastructure.
4Reliability
If single-use disposable bags are used, then contamination risk and initial installation cost are reduced, but operation cost and labor input increase
Solution Approach 1:
The automated control unit manages the entire single-use bag system without manual intervention. It automatically controls pumps, monitors flow rates, manages valve operations, and handles bag replacement scheduling. This self-service automation eliminates the need for manual buffer preparation labor while maintaining the contamination resistance benefits of single-use disposables.
Data Source
AI summary
The present invention provides a buffer preparation and transfer system for a process of manufacturing an antibody pharmaceutical which can reduce the input of a lot of labor due to the preparation of each buffer, including the weighing of a buffer chemical, the input of a powder, stirring and transfer, and significantly shorten process time by positioning and designing components in a manner that automates the preparation and transfer of various buffer solutions using a control unit and controls the concentration and composition of a buffer by transferring a concentrated component solution into the buffer storage tank using an opening/closing valve and a flow rate-adjusting valve, and unlike the related art, reduces the number of buffer preparation tanks corresponding to individual buffer storage tanks, which is advantageous for securing a safe distance between processes and securing a facility area.