The is an innovative, robust, and flexible cGMP cell manufacturing platform. Enabled by the CAMP™ technology and utilizing a single-use “end to end” solution.
The delivers cell therapy manufacturing as close as possible to the bedside. Allowing optimized culture conditions with tight quality assurance, resulting in significant cost reduction, therefore, ensuring availability of advanced therapies to patients.
The platform contains several compartments:
- Controlled temperature chamber for fresh media and supplements.
- Core reaction chamber - incubator with 6 pumps, 4 valves and a variety of sensors allowing the movement of media and supplements in a fully controlled and programable manner.
- Waste chamber with empty sterile bags for used media coming out of the reaction ensuring closure and safety.
- A user-friendly operating system that controls and monitors 14 parameters during the process.
Controlled Colling Chamber – Unique chamber that allows fresh media bags to be stored in the optimal condition through the process. The fresh media bags in the chamber are connected by tubes to the conditioning chamber and can be replaced easily as needed.
Waste Chamber – External chamber in which the waste bags are located. The bags are connected to the single-use kit and allow waste to be emptied continuously during the process.
Core Reaction Chamber - Core reaction chamber is equipped with pull out drawer for easy kit installation with click-on optical sensors and a preset position for simplicity. The chamber includes all of the needed pumps, valves, sensors, and connectors, temperature-controlled allowing optimal conditions for cell growth.
Operating System - A modern operating system that allows remote control and monitoring of the process. The system contains software that enables the programming and design of any predefined protocols, by the end-user. The system processes the data collected from the various sensors and operates pumps, alerts, and controls accordingly.
Platform Advantages and Features
- Single-use - Closed System - The kit in which the reaction occurs is a USP class 6 single-use kit allowing easy assembly and closed processing. The closed single-use unit eliminates the need for cleaning validation between runs, allows a reduction in the cleanroom requirements, and saves expensive labor, infrastructure, and risk. Furthermore, the fact that the kit is a closed system, results in complete segregation between different processes in the same room allowing efficient utilization of the clean rooms. Easy aseptic connectors, ergonomic design, and automated integrity testing result in a simple to use and safe reaction unit. The kit is designed for flexibility to enable a variety of the different processes done within the same kit further simplifying the use.
- Powerful Optical and Biosensor - Monitoring and online controlling the levels of 14 different parameters including glucose, lactate, glutamine, glutamate, temperature, volumes, pressure, N2, O2, air, CO2, pH, and dissolved oxygen. All of the monitored and controlled sensors are located separately in both “The Cone” and “Conditioning Chamber” allowing optimal conditions and flexibility for various applications resulting in a preferred and controlled environment for cell growth.
- Scale-up - The “Cone” is designed for continuous cultivation and expansion from 20 million cells as the starting material and up to 20 billion harvested cells. The system monitors, learns and optimize the process online based on the preset parameters and setpoints, by adapting its feeding regimen to the dynamic behavior of the expanded cells. We have the ability to scale up or scale down our unique "Cone" to fit your process.
- Scale-out – At the same size of a lower grade clean room you can now place several platforms for manufacturing several processes at the same time, with minimal labor, space, or infrastructure.
- Remote Access and Flexibly – the system is equipped with secure remote access, an alarm system, and notifications. Now you can online monitor and control the reactions 24/7 from outside the cleanrooms, get alarms if the reaction is behaving differently, and intervene if needed. Now you can enjoy your weekends by fully remote access to the system, from your computer with secure remote access. Get notifications and alarms to keep your system running. We provide modularity and flexible software for custom protocols and data log’s to ensure the quality and cGMP CFR21 part 11 data integrity