December 09, 2021

Taiyo Pharma Tech to establish gene therapy manufacturing using Cytiva’s FlexFactory™ solution

By Cytiva
  • Taiyo Pharma Tech’s new production line will make a new type of therapy
  • Cytiva’s FlexFactory platform can help reduce time-to-market by up to 50%

In a race to become one of the first contract manufacturers to enter the Japanese domestic gene therapy market, Taiyo Pharma Tech Co., Ltd. will establish a new Cytiva FlexFactory platform at its site in Osaka, Japan. The new manufacturing equipment will be used to make gene therapy medicines based on AAV (adeno-associated viruses)1.

Cytiva’s FlexFactory is a one-stop solution for equipment and services following single-use technology and a modular design tailored to the manufacturer’s needs. For Taiyo Pharma Tech, the anticipated time to install and open its factory will take approximately 14 months, significantly less than the industry standard of two years. Single-use technology also brings benefits such as removing complex cleaning steps, reducing the risk of contamination as well as enabling high-mix manufacturing. These benefits increase speed to market, helping accelerate the new CMO’s response to the domestic gene therapy market and service the needs of patients across Japan.

Taiyo Pharma Tech’s Osaka site where Cytiva’s FlexFactory will be established

Taiyo Pharma Tech’s Osaka site where Cytiva’s FlexFactory will be established

Tomotsuna Nakagaki, Senior Director of New Business Development in Taiyo Pharma Tech says: “The design and construction of a new biomanufacturing facility usually requires significant capital investment and a long lead time. These conventional, site-assembled facilities use stainless steel equipment and require coordination between multiple equipment manufacturers. With FlexFactory, not only are we able to tailor production based on specifications and reduce capital expenditure, but we are also able to address demand with speed and potentially reduce time-to-market by half. We can move confidently forward in our plans to make new medicines available quickly for the Japanese market.”

Stephane Perrey, General Manager of Cytiva in Japan, adds: "The coronavirus pandemic was a stark reminder that we must ensure access everywhere to new medicines and vaccines. To meet current and future demands, countries need to strengthen domestic manufacturing alongside the global supply chain. With few CMOs in Japan today, there is huge potential for building local manufacturing in Japan for Japan. We are pleased that the plug and play nature of the FlexFactory platform enables rapid scale up or scale out to support the rapidly growing biotech market in Japan now and into the future.”

The well-documented potential of gene therapy to treat serious and rare diseases has driven competitive pressure to shorten the time from discovery to market. The size of the Japanese regenerative medicine and gene therapy market is estimated to increase 16 times, from 57 billion JPY in 2020 to 910 billion JPY in 20402. About 70% of gene therapy drugs are developed by biotech start-ups and venture companies, and majority of them rely on contract manufacturers for production needs. Equipping contract manufacturers, such as Taiyo Pharma Tech, with the right capabilities will have a major impact on the future supply of gene therapy drugs in Japan.

Taiyo Pharma Tech has the honor of being the 100th Cytiva FlexFactory.

About Taiyo Pharma Tech

Takatsuki plant, the base of Taiyo Pharma Tech started its operation in December 1933 and had been playing an important role as Daiichi Sankyo Group’s largest plants in the west area of Japan for over 85 years. The quality and the stability of the plant shall be maintained, after joining the Taiyo Holdings group in 2019. Now, Taiyo Pharma Tech is introducing and developing technologies for contract manufacturing of new modalities such as regenerative medicine and gene therapy.

About Cytiva

Cytiva is a global life sciences leader with more than 8000 associates across 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacturing and delivery of transformative medicines to patients.

Media Contact

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(1) AAVs is commonly used as vectors to introduce therapeutic genes into host cells, which are safe because they are derived from non-pathogenic viruses and are unlikely to be incorporated into chromosomes. It is also characterized by high efficiency of gene expression, long-term persistent expression (sustained effect after a single dose) and minimal adverse effects on the patient.

(2) Source: "Analysis of Domestic and International Development Trends, Market Size Projections, and Investment Trends by Overseas Governments" (Arthur D. Little Japan, 2 September 2020), a handout from the First Meeting of the Council for the Development of Regenerative and Cellular Medicine and Gene Therapy, which was held by Cabinet Office of Japan