FOR IMMEDIATE RELEASE
July 8, 2025













 

Cyto-Facto Launches “CytoFactory 4.0™” – A Cloud-Based Integrated Manufacturing Management System for ATMP Production

— Optimizing quality, speed, and compliance in gene and cell therapy manufacturing —

Kobe, Japan – Cyto-Facto Inc. (Head Office: Kobe, Hyogo; CEO: Shin Kawamata) today announced the official launch of CytoFactory 4.0™ Ver.1, a cloud-based integrated manufacturing management system designed specifically for the production of advanced therapy medicinal products (ATMPs).
As gene and cell therapies move toward widespread clinical use, many manufacturing facilities continue to face challenges in digitization and operational efficiency. Paper-based batch records and manual workflows are still common, often resulting in hundreds of pages per batch, significant labor, and increased risk of human error. Additionally, the highly personalized and complex nature of cell therapy production makes conventional manufacturing systems ill-suited for the task.
CytoFactory 4.0™ was developed to address these challenges head-on, under the concept of “transforming the future of cell therapy manufacturing through purpose-built digital solutions.”

Key Features of CytoFactory 4.0™

• Built for ATMP Manufacturing
  Equipped with essential functions from raw material intake to manufacturing instructions, scheduling, quality control, and shipment release—all designed to meet the unique demands of gene and cell therapy production.
• Cloud-Based and Easy to Deploy
  Delivered as a SaaS platform, CF4.0 eliminates the need for dedicated servers and large upfront investment. Regular updates and maintenance are managed by Cyto-Facto, minimizing operational burden.
• Fully Digital and Integrated Manufacturing Environment
  Through IIoT interfaces, CF4.0 connects with manufacturing equipment, testing devices, and facility systems, enabling centralized and secure data management—laying the foundation for future data analytics and AI applications.
• On-Site Expertise and Support
  Implementation and operations are supported by Cyto-Facto's experienced team, with services including MBR development and computer system validation (CSV) support tailored to your specific needs.

（Process Overview）

The system incorporates BatchLine, a lightweight MES solution already in use by leading manufacturers worldwide. As the official distributor in Japan, Cyto-Facto also provides full implementation services for BatchLine.

Rollout Plan

CF4.0 Ver.1 will first be deployed at Cyto-Facto’s own production facilities. Based on real-world use and iterative improvements, the system will be made available to pharmaceutical companies, CDMOs, and academic institutions starting in 2026.

Try CytoFactory 4.0™ at INTERPHEX Week Tokyo 2025

Experience a live demo of CF4.0 at our booth during the following exhibition:
Event: INTERPHEX Week Tokyo / Regenerative Medicine EXPO 2025
Dates: July 9 (Wed) – 11 (Fri), 2025
Venue: Tokyo Big Sight, West Hall 2
Booth No.: W6-14
Our team will be available for system demonstrations and consultations throughout the event.

About Cyto-Facto Inc.

Cyto-Facto Inc. is dedicated to realizing a future where innovative gene and cell therapies reach patients faster and more reliably. By combining expertise in regenerative medicine with digital manufacturing innovation, we empower the next generation of pharmaceutical production.

For media or partnership inquiries, please contact:
Cyto-Facto Inc. – Corporate Strategy Division
3F, Shimin Byoin-mae Bldg., 2-1-11 Minatojima Minamimachi,
Chuo-ku, Kobe, Hyogo 650-0047, Japan
Email: cf40-contact@cytofacto.com
Website: https://www.cytofactory.com/