In a race to become one of the first contract manufacturers to enter the Japanese domestic gene therapy market, Taiyo Pharma Tech 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).
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.
The plug and play nature of the FlexFactory platform enables rapid scale up or scale out
"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," said Tomotsuna Nakagaki, Senior Director of New Business Development in Taiyo Pharma Tech. "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, added: "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."
Perrey explained 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 ($0.6bn) in 2020 to 910 billion JPY ($8bn) 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 honour of being the 100th Cytiva FlexFactory.