Collaboration will boost capabilities to deliver cancer treatment within Thailand and to Southeast Asia by 2025 

Genepeutic Bio is on track to receive Thai FDA approval for the treatment by end of 2024

Genepeutic Bio aims to bring chimeric antigen receptor-T (CAR T) cell therapies to a few hundred patients with relapsed and refractory blood cancers such as acute lymphoid leukemia (ALL) in  Thailand and Southeast Asia by 2025. The company has also applied for Thai Food and Drug  Administration (FDA) approval for this treatment and hopes to receive approval by end of 2024.

The research and development of cell and gene therapies, such as CAR T cell therapies, is gaining  visibility in Thailand. In late April 2023, Thailand Center of Excellence for Life Sciences (TCELS), the  Ministry of Higher Education, Science, Research, and Innovation, the Federation of Thai Industries  (FTI), the Board of Trade of Thailand, and the Office of Small and Medium Enterprises Promotion  (OSMEP), have announced a combined effort to elevate the life science industry as one of the country’s top growth pillars and propel Thailand to become a high-value medical and health hub. 

Dr Parin Rattananon, CEO of Genepeutic Bio, says: “Cytiva’s comprehensive solution solidifies our  position as a trusted industry service provider within Thailand and in Southeast Asia. This  enhanced manufacturing capability will allow us to meet Thailand’s domestic healthcare demands  and bring us one step closer to realizing our vision of providing novel treatment for all.” 

Premnath Mandalapu, Commercial General Manager, ASEAN, Cytiva, says: “Developing and  manufacturing new therapies requires flexibility, speed, agility, and scale. It also requires having  access to GMP (good manufacturing practice) capable engineers to navigate the certification  process. Our FlexFactory platform addresses those requirements and is trusted by customers,  with more than 100 installations around the world. Now in Thailand for the first time, our  FlexFactory will enable Genepeutic Bio to bring the next generation of medicines to patients in  Thailand and Southeast Asia who need them most.” 

Data from Cytiva’s 2023 Global Biopharma Resilience Index shows that having better access to biopharma talent will facilitate progress in Thailand. 32 percent of respondents in Thailand,  compared to the average of 59 percent of respondents globally, are positive about having access to GMP-capable talent. 

Cytiva’s FlexFactory biomanufacturing platform includes cell therapy instrumentation,  qualification and documentation packages, project management consulting and training services,  and the Chronicle automation software platform. It provides an integrated, scalable solution for  acceleration and translation to GMP manufacturing, and takes approximately nine months to  install and validate.