Automated Cell Manufacturing System with Sterile Transfer Interfaces
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for manufacturing therapeutic cells for adoptive cell therapy, such as CAR-T cell-based treatments, are time-consuming, expensive, and prone to human error due to manual handling and variability in patient-specific starting materials, making them inefficient and costly.
Innovation Solution
A system for non-parallel random access manufacturing of cells that allows multiple cell culture vessels to undergo different manufacturing steps simultaneously, featuring automated or manual handling, with a controller scheduling movements and enabling sterile connection and liquid transfer, reducing the risk of contamination and increasing productivity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual handling and processing of cell culture vessels is used, then flexibility in handling patient-specific starting materials is maintained, but productivity is low and human error increases
Solution Approach 1:
The system enables self-service automation where the automated handling device independently performs operations on cell culture vessels without continuous human intervention. The device can autonomously transfer vessels between incubators and workstations, perform manufacturing operations, and manage the production process, thereby increasing productivity while maintaining flexibility through programmable control.
2Productivity
If multiple cell culture vessels are processed in parallel, then productivity increases, but contamination risk increases due to more frequent openings and handling
Solution Approach 1:
The system segments the production process by providing dedicated workstations for different manufacturing operations (e.g., transduction workstation, expansion workstation). Each workstation is equipped with specialized equipment and can process multiple vessels simultaneously in a controlled environment, increasing productivity while maintaining sterility through spatial separation of functions.
Solution Approach 2:
The automated handling device acts as an intermediary between the external environment and the sterile cell culture vessels. It enables transfer and processing of vessels without requiring frequent opening of incubators or direct human contact with sterile contents, thereby maintaining contamination control while enabling high-volume processing.
3Productivity
If fully automated processing is implemented, then productivity and consistency improve, but device complexity and initial cost increase
Solution Approach 1:
The automated handling device is designed with multi-functionality, serving as a universal platform that can perform various manufacturing operations on different cell culture vessels. It can transfer vessels between incubators, load/unload workstations, and coordinate different processing steps, thereby achieving high productivity without requiring separate specialized equipment for each function.
Solution Approach 2:
The system employs dynamic scheduling capabilities where the automated handling device can adapt its operations based on real-time production needs, vessel status, and workstation availability. This flexibility allows the system to optimize productivity while managing complexity through intelligent control rather than rigid fixed sequences.
4Adaptability or versatility
If frequent access to cell culture vessels is performed for manufacturing operations, then processing flexibility is maintained, but contamination risk increases
Solution Approach 1:
The automated handling device serves as an intermediary that enables frequent access to cell culture vessels for various manufacturing operations without compromising sterility. It can perform transfers, load/unload operations, and coordinate processing steps while maintaining closed systems and minimizing exposure to the external environment, thereby preserving both flexibility and contamination control.
Data Source
AI summary
Systems for semi or fully automated non-parallel random access manufacturing of cells comprising (a) an incubator arranged to house multiple cell culture vessels, and (b) one or more connection interfaces, each of which comprises (i) a first connector, and (ii) a first sterilizable space, wherein the first connector is operable to connect a first container and a cell culture vessel in the first sterilizable space. Also provided herein are methods for manufacturing cells using the systems provided herein.