SINFONIA TECHNOLOGY CO., LTD. (Head office: Minato-ku, Tokyo; President: Fuminori Saito) has been developing a fully automated cell culture instrument in collaboration with the Foundation for Biomedical Research and Innovation at Kobe (FBRI; Locations: Kobe City, Hyogo Prefect.; President: Tasuku Honjo, M.D.，Ph.D.). With the successful results of demonstration experiments with human iPS cells and mesenchymal stem cells, SINFONIA announces the official product launch starting from October 2021.

Regenerative medicine is expected to be the next generation therapy; some products have already been approved and distributed, for example, for adverse events after hematopoietic stem cell transplantation for acute leukemia and for spinal cord injury. Clinical trials of a number of cell therapies are also ongoing globally to treat diseases that are intractable to existing pharmaceuticals, such as hepatic cirrhosis, myocardial infarction, stroke, diabetes, kidney diseases, as well as emerging pneumonia caused by COVID-19 infection. It is expected that the regenerative medicine market will continue to grow strongly as one of the most promising industrial sectors.

Products of regenerative medicine differ from general industrial products, because "cells," which are both raw materials and active ingredients, are living entities. Cells are individually different, and subtle environmental changes and differences in process protocols greatly affect their quality in culture, which is the process to expand or process cells. Cell manufacturing is still widely dependent on following a manual process by highly skilled operators, therefore, automation of the culture process to increase the production efficiency is now a significant challenge.

Since the quality assessment of cellular products during normal cell growth is extremely difficult, it is very important to adopt the concept of Quality by Design (QbD) which is "quality control throughout the entire cell manufacturing process by constant monitoring, and ensuring the quality of the product by fully controlling the quality of the process". We have been developing and evaluating a novel cell culture instrument equipped with the functions necessary to monitor the manufacturing process of the cells under the guidance of Dr. Shin Kawamata, Director of the FBRI Cell Therapy Research and Development Center, an international leader in the quality control of cell manufacturing.

The newly developed product named the ‘CellQualia Intelligent Cell Processing (ICP) System’makes it easy to set up complex culture process parameters from a tablet PC, and the status of cells during culturing can be monitored in real time with chemical sensors and cell imaging. In addition, a volume of culture medium can be withdrawn at a desired timepoint for more detailed analyses such as mass spectrometry and immunochemical measurement. The data thus acquired can be used not only for quality control but also to direct further improvement to the manufacturing process.

To ensure sterility, which is a requirement for Cell & Gene Therapy Products, all elements that come into contact with the culture media and cells are connected aseptically with tubing, and all processes are completely closed and separated from the outer environment. In addition to the automated exchange of culture medium containing nutrients for cells to grow, the CellQualia ICP system is equipped with an automated passaging function to transfer cells into culture vessels of different sizes for serial expansion of the cells. Overall, the entire process from seeding to harvesting of the cells is automated and all data are consolidated, making the CellQualia ICP system very effective in both labor saving and in manufacturing with full quality control.

To enable our customers to experience the usefulness of CellQualia ICP system, SINFONIA plans to open a ‘Solution Lab’ in March 2022 as a separate section of the cell contract manufacturing facility under development by FBRI (scheduled to be completed: February 2022) on the 5th floor of the Kobe Medical Innovation Center. In addition to customers’ visit and culture evaluations with their own cells, this facility will also allow users to conduct pilot manufacturing on a contract basis. Customers will experience QbD, which is essential for the manufacture of high-quality regenerative medicine products, by using the instrument in this facility and SINFONIA will support those who install and execute it. An on-going demonstration experiment of the QbD concept with a UK agency since 2019, partially affected by COVID-19 pandemic, is also finally ready and can be started by the end of this fiscal year.

Starting with the launch of this instrument, SINFONIA will roll-out its regenerative medicine products business under the brand name CellQualia (the word from Cell and Qualia = texture), aiming to reach sales of 5 billion yen by 2025. With the launch of this innovative new product, SINFONIA is making its first steps to provide high-quality regenerative medicine to patients at a low cost.