Cyto-Facto Inc.: Advancing cell & gene therapies, providing the promise of health

Vaisala Oyj
Wednesday, 01 November, 2023

Cyto-Facto Inc.: Advancing cell & gene therapies, providing the promise of health

In April 2023, Cyto-Facto Inc. (CF), a spin-off of the Foundation for Biomedical Research and Innovation at Kobe, Japan, began manufacturing gene and cell preparations to meet a worldwide growing need for new treatments that leverage a patient’s immune system to fight disease. One example is an emergent gene therapy like CAR-T (Chimeric Antigen Receptor T-cell/CAR-T cell), which is showing enormous promise in the treatment of lymphatic cancers. However, robust process needs, including controlled, sterile environments, make the manufacture of cell and gene therapies complex and costly.

With a solid track record in R&D and manufacturing investigational and commercial products, Cyto-Facto Inc. has long experience in compliance with GMP (Good Manufacturing Practice), and process development for gene and cell preparations. A large team of accomplished personnel has allowed Cyto-Facto Inc. to begin developing and producing life-saving drugs and treatments.

Cyto-Facto Inc. CEO and President Shin Kawamata has faith in the competency of the company’s staff. “Because the raw materials for cellular medicine are living organisms, sterility and standardization are difficult to achieve, as is proper implementation of the manufacturing process,” said Kawamata. “The need to maintain a heavy-duty HVAC system and high costs are hurdles to commercialization and industrialization. In addition, the initial stage requires manual manufacturing methods, which must be performed by skilled personnel.”

Compliance with Good Practices for GCTP

While conventional drug and medical device reviews focus on the technical aspects of manufacturing and quality control, the regulations regarding GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice - Source PMDA) require more specialized knowledge of the biological properties of cells and tissues and their therapeutic effects. Because GCTP products are individualized therapies that utilize the cells and tissues of an organism, unlike conventional small molecule-based drugs, clinical trials and reviews are conducted on an individual basis, with stricter rules for the production and management of products to ensure safety and efficacy.

CF implemented the Vaisala viewLinc continuous monitoring system in their controlled environments to ensure compliance with strict GCTP regulations. Since CF provides Cell Processing Centers (CPCs) for clinical trials and commercial development, the company needs to meet the requirements of each client, including the layout of the equipment in the processing center and the items to be monitored.

The Vaisala viewLinc monitoring system can be configured with wireless data loggers to flexibly accommodate layout changes. In addition, the ability to use virtual servers and the ease-of-use of the software interface are ideal for managing the complex CPCs. As a sensor manufacturer, Vaisala also offers a wide array of measured parameters, device connectivity options, and support services. With audit trail and user administration features, the viewLinc software is compliant with GxP and global regulations. Vaisala also supports compliance with its GxP documentation package and comprehensive IQOQ protocols.

Before the viewLinc monitoring system was installed, Cyto-Facto Inc. conducted a preliminary radio signal test to verify that viewLinc’s RFL100 data loggers’ wireless communication was fully functional across CPCs in separate buildings. This initial demonstration allowed for the AP10 network access points and wireless data loggers to be properly positioned and the system was implemented quickly.

Environmental Monitoring before viewLinc

Prior to the introduction of the Vaisala continuous monitoring system, sensors without data logging capabilities sent environmental data to a centralized monitoring system. However, this entailed the risk of data loss in the event of a communication failure. In addition, the old system required an on-premise server, supported by periodic data backups and maintenance, which placed an extra burden on staff. The monitoring system software only provided one level of access privileges. Access privileges were granted only to specific personnel who had received training, to limit the number of operators and avoid errors and data modification. With Vaisala’s viewLinc monitoring system, detailed user access permissions can be configured at multiple levels to achieve highly secure operations with flexible and lean staffing. Easy administration of user access rights also supports GxP compliance.

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