ETANA'S MRNA VACCINE PRODUCTION FACILITY RECEIVES BPOM'S VISIT
Jakarta, 25 October 2023 – PT Etana Biotechnologies Indonesia (Etana), an indigenous Indonesian biopharmaceutical company, today received a visit from the Head of the Food and Drug Supervisory Agency (BPOM) to review the readiness of the production facility for raw materials for mRNA vaccines and multi-product filling facilities. Concurrently during the visit, they also handed over the approval for distribution permits and approval for the implementation of clinical trials for the PCV13 vaccine product that will be produced by Etana.
Dr. Penny K. Lukito MCP, Head of the POM Agency said "I would like to give my appreciation to Etana for continuing to support the government's efforts in the health sector. Ethane continues to experience continuous and rapid development because it has the valued trust of its investors and sufficient human resources. The biopharmaceutical industry has quite significant challenges in terms of investment and human resources but in the future it will be a priority, I noticed that Etana is grabbing the excellent opportunity. "
Andreas Donny Prakasa, Head of Corporate Relations of PT Etana Biotechnologies Indonesia said, "We appreciate the support that BPOM has provided so far to Etana to produce high quality, affordable and innovative biological and vaccine products through technology transfer. "This is a form of our commitment to produce biological drugs and vaccines locally as an effort to support the Government in creating national independence and resilience in the health sector."
Etana became the first pharmaceutical company in ASEAN to have mRNA technology. MRNA technology is a flexible production platform for vaccines and various biopharmaceutical products that can accelerate the development of biopharmaceutical products. When compared with conventional platforms, the development of new vaccines using mRNA technology cuts down a lot of development time until they are ready to enter the clinical trial phase.
"By obtaining the distribution permit and implementation of the clinical trials for the PCV13 vaccine product, we will strive to support the government's program to prevent pneumonia in Indonesia. "As we know, pneumococcal disease is the biggest cause of death for children under five in Indonesia," continued Andreas.
Etana at a glance
Established in 2014, Etana is an Indonesian biopharmaceutical company that researches, manufactures and markets biological products for the Southeast Asian market. With a mission to serve patients by providing high quality, affordable, and innovative therapies, Etana has built state-of-the-art local production facility with sophisticated technology that meet the international and Indonesian FDA standards. Etana's facility is able to produce biological therapy with halal certification from the Indonesian Ulema Council (MUI). Etana aspires to become a leading biopharmaceutical company in the ASEAN region through aggressive expansion in production capacity and product development, with a primary focus on oncology and vaccine products.
Etana is led by a local management team who come from various international and domestic educational backgrounds and have strong experience in the biopharmaceutical industry, and are supported by a team of international investors and leading biopharmaceutical companies. Etana aims to provide innovative and affordable biopharmaceutical products through local production, to support the Indonesian government program and international market demand. Etana is committed to research, development and production of biopharmaceutical products such as vaccines, monoclonal antibodies, and other biopharmaceutical products. For more information on Etana, visit: www.id.etanabiotech.com