Dr. Kitipong and Prem Mandalapu further discuss the pivotal partnership between Genepeutic Bio and Cytiva, highlighting how their collaboration contributes to local production, accessibility, and affordability of advanced therapeutics. The utilization of Cytiva’s advanced technologies and FlexFactory™ biomanufacturing platform empowers Genepeutic Bio to streamline their processes, ensuring high-quality production and patient-centric care. This partnership, they assert, signifies more than a vendor-client relationship; it demonstrates a commitment to enhancing healthcare outcomes.

1. Could you both elaborate on the significance of Thailand's first GMP-certified cell therapy manufacturing facility and how it aligns with the country's vision of becoming a high-value medical and health hub in the region?

Dr. Kitipong: This is one of the biggest milestones for the country. Cell and gene therapy has received much attention recently, with the resurgence in the number of preclinical and clinical studies in this area. With the presence of such a facility, our country is not behind in term of medical advancement. In addition, this facility does not only prove that we can bring innovation to commercialization that meets international standards, but also enable the patients within Thailand and our surrounding neighbours to be exposed to, and use an advanced medicinal product which is efficacious to treat diseases which otherwise there is no hope for, at an affordable price.

Thailand is eager to be a one-stop shop for healthcare services, where patients can be treated in the local hospitals, with medication manufactured within the country, to avoid any delays and damage during logistic. At the same time, Thailand is keen to promote medical tourism to increase the revenue within the country. This first cell and gene therapy manufacturing facility acts as a linkage between the hospital and patients to allow for the complete supply chain of a high-value medical and healthcare hub.

Prem Mandalapu: To add on to what Dr Kitipong shared, Cytiva is very proud of Genepeutic Bio for establishing the first GMP-certified cell therapy manufacturing facility in Thailand. This is no small feat. Data from Cytiva’s 2023 Global Biopharma Resilience Index shows that having access to GMP-capable talent who can navigate the certification process is more challenging in Thailand than the rest of the world. By providing an integrated, scalable solution for Genepeutic Bio to accelerate, and translate to, GMP manufacturing, they now play their part to make the life sciences industry one of Thailand’s top 10 growth pillars.

2. The establishment of this facility is a remarkable achievement. How do you envision it addressing the increasing market demands for advanced therapeutics not only in Thailand but also in the broader ASEAN region?

Dr. Kitipong: The capacity of the production within the current facility is approximately 50 patients per year, with the capacity to expand up to 200 patients within a year. Therefore, the increasing demand in such a personalized treatment can definitely be met. This is not only for the production of medicinal product to treat a single disease; the facility is also able to be flexible with its production based on the gene target of interest to potentially treat other genetic oncologic diseases.

3. Kitipong, as CSO of Genepeutic Bio, could you delve into the collaboration between Genepeutic Bio and Cytiva? How will this partnership enhance local production, accessibility, and affordability of advanced therapeutics, especially for cancer patients in both Thailand and the region?

Dr. Kitipong: Cytiva, as a company, is able to provide a full package for the production of such advanced therapeutic medical product, with the know-how and the full technical support. The use of Cytiva’s FlexFactory™ has not only allowed us to save time in performing process development but also enable us to learn from each other on how to better our processes for the production. The patients in Thailand will benefit from the treatment processed by Cytiva’s equipment due to the high-quality consumables, equipment and reagents. In addition, we feel that Cytiva is not just a vendor, but the team actually do care for us after the sale.

4. Mandalapu, the facility boasts state-of-the-art capabilities. How will these cutting-edge features contribute to creating a reliable supply chain and ensuring a consistent flow of advanced therapies to patients who are eagerly waiting for them?

Mr. Mandalapu: Cytiva’s FlexFactory™ biomanufacturing platform is an agile bioprocess platform which includes cell therapy instrumentation, qualification and documentation packages, project management consulting and training services, and the Chronicle GMP automation software platform. Altogether, this provides an integrated, scalable solution for acceleration and translation to GMP manufacturing, and takes approximately nine months to install and validate. As such, the FlexFactory™ platform offers Genepeutic Bio production line flexibility and operational efficiency so that they can easily adapt to and address current and future capacity needs. This in turn will help them deliver therapies to patients who need them locally and in the region in a timely manner.

5. One of the most impactful aspects of this achievement is the transformation it brings to patients' lives. Can you share some insights into the profound changes and improvements that patients can anticipate due to the therapies produced at this facility?

Dr. Kitipong: The current product that the company is carrying it into the clinical trial is used to treat patients with relapsed/refractory acute lymphoid leukemia (ALL). Without such a treatment, the patient has no further hope. ALL usually occurs in children and young adults, who otherwise should have a bright future ahead. This treatment can assist in giving them hope for extending their life expectancy and also improve their quality of life. Without such a company within the country, the patient has to personally find such treatment overseas, which can be very expensive and maybe met with logistic problems. In addition, these patients may not even know if such an advanced therapy exists so they may have missed this good opportunity.

6. Scaling production is a crucial step in realizing the full potential of this facility. How do you foresee this facility supporting local scientists and process developers in achieving the necessary scalability to meet the growing demand for advanced therapeutics?

Dr. Kitipong: This facility has the capacity to scale up to 200 patients a year. As demand increases, there is a need to increase the facility, together with advancement in cell and gene therapy, this facility can accommodate all needed with the know-how and the techniques available (through further collaboration with Cytiva). This means that there is a need to increase the local production and release testing workforce, where local scientists will be able to be recruited to work within the facility. Thailand is eager to transition to a knowledge economy, driven by a trained workforce that can turn Thailand into a regional innovation hub.

arcilla.fran@biopharmaapac.com