Applications

CAR-T

Chimeric antigen receptor (CAR) T-cell therapy represents a major advancement in personalized cancer treatment. In this strategy, a patient's own T cells are genetically engineered to express a synthetic receptor that binds a tumour antigen. CAR T cells are then expanded for clinical use and infused back into the patient's body to attack and destroy chemotherapy-resistant cancer1.
Today, all commercialized CAR T cell products are manufactured using open methods and relying on manual cell handling2. We developed an innovative, de-centralized, flexible, automated, cGMP manufacturing platform, called the ADVA, which will allow point of care manufacturing, reduce costs, while ensuring the 

quality and availability of the disruptive, personalized Immune cell therapy for cancer patients worldwide.

Simplify your CAR-T Process with the ADVAX3

The ADVA  is all-in-one system that performs the entire CAR T process - from the activation, genetic modification, cell expansion, washing to final cell product in one automated process with minimal user involvement.
The ADVA  enable a controlled monitored CAR T cell manufacturing process with buffers of your choice. The cells are expanded in our sterile, closed CX-900 kit to up to 20 billion cells in one single kit. At the end of the process, the CAR T cells are ready for cryopreservation or infusion

TCR

T Cell Receptor (TCR) therapy is another type of immune cell therapy similar to CAR T, in which instead of an engineered T cell receptor the transduced receptor is a native tumor T cell receptor. The main advantage in this therapy is its minimal toxicity as the T cell still maintains its natural “controls” leading to higher safety profile. The manufacturing profile costs are similar to CAR T.

Large-scale production of TCR transduced T-cells using the

The ADVA  is designed for large scale production of transduced T-cells in a closed, fully automated system, enabling live control of different culture parameters (pH, Dissolved Oxygen, Temperature, Glucose, Lactate, Glutamine, Glutamate…) which are crucial to insure viable and quality TCR transduced T-cells in a cGMP condition. Use our CX-900 kit to achieve up to 1000- fold expansion in a single run.

TIL

Another emerging immune cell therapy for cancer is called Tumor Infiltrating Lymphocyte (TIL). The treatment involves the large-scale expansion of TIL (containing T cells) in vitro from tumor specimens followed with Interleukin-2 (IL-2) as a growth factor, selected TIL lines that presented best tumor reactivity are then further expanded in a "rapid expansion protocol" (REP), which uses anti-CD3 activation for a typical period of two weeks. The final post-REP TIL is infused back into cancer patients where they home into and attack tumors.
One of the main drawbacks of this therapy is the long, labor-intensive manufacturing process and the high dosage that are needed for treatment. 

The NIH published treatment cost for clinical trials are currently $500,000 USD.

 

One system for TIL complete manufacturing process


The NIH published treatment cost for clinical trials are currently $500,000 USD.

One system for TIL complete manufacturing process

The ADVA  offers an automated TIL manufacturing process of the pre-REP and REP step in one single chamber! The tumor specimens are infused to the ADVA cone chamber following a rapid cell expansion with buffer and growth factor of your choice. The buffers and the medium can be kept in the ADVA cooling chamber for long and quality process use. For more information about our CX-900TL kit please contact us.

NK

Natural Killer (NK) cells are cytotoxic immune cells with an innate capacity for eliminating transformed cells in a non-major histocompatibility complex (MHC) and non-tumor antigen-restricted manner. NK cells can offer several advantages over T cells for CAR therapy in that the former uses both a CAR dependent and independent mechanism for tumor eradication, has better safety, and off-the-shelf feasibility. Different strategies have been developed using NK cells to fight cancer including CAR NK and NK combined with immune therapy.

 Recent clinical trials have shown impressive and processing response of cancer patients to NK treatments.

Automation and AI technology monitoring your NK cell manufacturing

 Recent clinical trials have shown impressive and processing response of cancer patients to NK treatments.

The ADVA automated NK cell activation transduction, expansion and final cell product is performed in one closed system. The high level of AI (Artificial Intelligence) enables live monitoring and control of quality genetically transformed NK cells for future clinical applications.

Exosomes

Exosomes are extracellular vesicles secreted by most eukaryotic cells and participate in intercellular communication. The components of exosomes, including proteins, DNA, mRNA, microRNA, long noncoding RNA, circular RNA, etc., which play a crucial role in regulating tumor growth, metastasis, and angiogenesis in the process of cancer development, and can be used as a prognostic marker and/or grading basis for tumor patients3.

Exosomes production under standard lab culture protocols is a significantly time consuming.

The culture capabilities of growing high amounts of cells, exosomes collection and purification would require months of work, and significant capacity of perishables but more importantly manpower.

Exosome mass production with the ADVAX3

The ADVA provides a controlled and continuous exosome production with 100 trillion exosomes with our CX-250E single kit. To compare, in regular production with the same time and the same media volume, about 10 billion, that is 10,000 times less!

Virus

Virus production techniques were originally developed for the manufacture of vaccines, but they are now becoming more important in other areas of the biopharmaceutical industry. The scope for therapeutic strategies has broadened and now encompasses vectors for replacement protein expression, gene therapy and the treatment of cancer4.
Regulatory requirements stipulate that the production of any agents intended for use in human clinical trials must be performed under current Good Manufacturing Practices (cGMP). Retroviral vector stocks (VS) to be used for the generation of genetically modified cellular therapeutics fall within these requirements.

 These entail the performance of all production activities in an aseptic manner and the removal of any potentially unsafe contaminants, such as viable vector-producing cells (VPCs), from the product.

cGMP-Closed single use kit for Virus production

Use the ADVA cGMP automated manufacturing platform and the CX-250V closed sterile kit for mass production of VS with multiple harvest cycles. The CX-250V is optimized for Retrovirus, Adeno and Lenti Virus production.

Exosome mass production with the ADVAX3

Use the ADVA  cGMP automated manufacturing platform and the CX-250V closed sterile kit for mass production of VS with multiple harvest cycles. The CX-250V is optimized for Retrovirus, Adeno and Lenti Virus production.