Can the ADVA-X3 identify metabolic alterations/switches in the cells?
Yes, as mentioned previously, the collected data enables the system to establish predictive models. The output of the monitored parameters is cross analyzed and interpreted by the incorporated Machine Learning (ML) and Artificial Intelligence (AI) computational power to predict metabolic alterations at any phase throughout the manufacturing process.
Can the ADVA-X3 predict the total cell number in the culture at given time point?
Yes, once enough data is collected, the system exhibits predictive capabilities. The output of the monitored parameters is cross analyzed and interpreted by the incorporated Machine Learning (ML) and Artificial Intelligence (AI) computational power to predict the total cell number in the cell culture at throughout the manufacturing process.
What distinguishes ADVA-X3 from other ACT manufacturing technologies?
- Monitoring and regulations of multiple metabolic and environmental parameters continuously, simultaneously, and automatically to guarantee optimal conditions for cells growth, proliferation, and differentiation, and to enable reliable detection of the cell culture growth and metabolic dynamics on real time.
- The continuous and simultaneous regulation of multiple parameters enables reproducibility and even predictability of total cell amount, cell quality and state in the system on every time point.
- Remote control of the system - Full control of the system from remote via secure portal on a PC, smart phone, or other mobile devices.
- Flexibility: No restriction for media or reagents type.
- Programable: Protocols and work plans can be programmed as desired by authorized user enabling a fully automated process execution by the device.
- An “all-in-one” device which can perform all process steps including: Cells Activation, viral transduction, expansion and washing steps within the device.
- Yield : 10X higher yields per chamber – up to 20 billion cells, thanks to optimal growth conditions and sheer force free growth environment.
What are the dimensions of the ADVA-X3 device?
80x80x80 cm3, 100Kg weight.
Can cells be sampled and estimated throughout the manufacturing process?
Yes. The ADVA-X3 system includes easy to use sampling ports that are designated for taking homogeneous samples easily and efficiently in aseptic and sterile manner, by connecting the sampling kit connector to the sampling port by clicking (without the need for welding).
On which regulatory standards does the ADVA-X3 stand?
The Adva X3 device is registered as a Class 1 Medical device (Registration Number: 3026937440) and had a Type V Master File for reference, it has been tested for compliance with CE (Conformit? Europ?enne), US FCC, Canada and other country-specific safety and EMC standards and guidelines.
Additionally, the Adva X3 Software is designed using GAMP5 standards (risk-based approach) and IEC 62304. The validated Adva X3 Software is compliant with FDA’s 21 CFR Part 11 and the European Union’s Annex 11 to enable computerized systems use during regulated manufacturing activities.
The company complies with ISO13485;2016 (Medical Device). All single use materials are USP Class 6 and ISO 10993-17/18.
Which steps of the ACT manufacturing can be performed in the ADVA-X3?
Cell selection, seeding, activation, transduction, expansion, washing and drug substance collection.
What is the minimal cell formulation volume?
Recommended minimal volume >100ml, lower volumes are doable but limit the ability to control the pH and DO levels.
What type of culturing methods are available in the ADVA-X3?
The ADVA-X3 might operate on each of the following modes: Batch-mode, Fed-Batch mode, close circulation, and Perfusion.
What is the volume range allowed by the ADVA-X3?
100 – 2700ml and then the system can switch into perfusion mode which practically eliminates the upper volume restriction.
Does the ADVA-X3 technology require defined and exclusive reagents or media type?
No. The ADVA-X3® is very flexible. There are NO restrictions on media type or reagents.
To which extent the ADVA-X3 protocols are programmable?
The ADVA-X3 is very flexible; protocols can be established modified by authorized users. Various strategies for Activation, Transduction, and Expansion can be implemented by modifying the flow paths, flow rates, culturing modes, volumes, time durations, events sequences, and more.
Are there ready to use protocols for the ACT manufacturing in the ADVA-X3 platform?
Yes. Standard protocol for CAR-T, TIL, TCRs, and exosomes manufacturing are available. Each one of these protocols is flexible and can be modified according to the user’s requirements by the user or Adva staff.
Which parameters does the ADVA-X3 monitor and/or regulate?
Glucose, lactate, glutamine, glutamate, temperature, volumes, pressure, flow rates, N2, O2, air, CO2, pH, and dissolved oxygen.
The Continuous Adaptive Multiparameter (CAMP) enables the ADVA-X3 to monitor and regulate up to 14 different parameters throughout the manufacturing process simultaneously, continuously, and automatically to guarantee optimal conditions for cell growth and proliferation. adapting to the specific consumption rates and demands of the cells as they grow maintaining optimal conditions throughout the culture.
What are the ranges of the cell burden in the ADVA-X3 system?
Yes. The ADVA-X3 can be adapted for adherent cells growth by the addition of special matrices or scaffolds which increase the surface area and contribute adherent cell growth.
Is the ADVA-X3 platform compatible for adherent cells growth?
Yes. The ADVA-X3 can be adapted for adherent cells growth by the addition of special matrices or scaffolds which increase the surface area and contribute adherent cell growth.
To which application the ADVA-X3 is intended?
The ADVA-X3 is primarily intended for ACT manufacturing; including CAR-T, TIL, TCRs, T-regs, NKs, etc. In addition, the ADVA-X3® is compatible for viruses and exosomes production.
What is the ADVA-X3 platform?
A cutting edge technology for Adoptive Cell therapy (ACT) manufacturing. An advanced cell manufacturing platform with multiple unit operations integrated to a sheer free highly controlled bioreactor which enables the manufacturing of cells in monitored and regulated conditions. The ADVA-X3® consists of two major components: the ADVA-X3 device and single use kits designed for different applications.
