Regional
Preparing Plasma for Fractionation: Indonesian Red Cross Experiences
In response to lessons learned during the COVID-19 pandemic, the Indonesian government took steps to become more self-reliant in the healthcare sector. During that time, Immunoglobulin - a critical therapeutic product - was difficult to obtain. Recognizing that Immunoglobulin is a Plasma-Derived Medicinal Product (PDMP), the government, under the coordination of the Ministry of Health, initiated efforts to establish a domestic plasma fractionation program.
The Indonesian Red Cross (IRC) had already launched its PDMP production initiative in the early 1990s and began enhancing the quality of its blood products by implementing Good Manufacturing Practices (GMP) in the early 2000s. In November 2017, the Surabaya Blood Center became the first IRC Blood Center to achieve GMP certification. As of 2025, 19 IRC Blood Centers are now GMP-certified. Following the government’s appointment of a plasma fractionator, the IRC began developing systems to prepare plasma for fractionation. These systems include:
- Transfusion Transmitted Infection (TTI) Testing
- Implementation of a System Information Management (SIM)
- Packing and Transportation of Plasma
1. Transfusion Transmitted Infection (TTI) Testing
Currently, most blood donations at IRC Blood Centers are screened using serological testing. Nucleic Acid Testing (NAT), a more sensitive method, is performed on a limited number of donations, typically based on clinical demand. However, preparing plasma for fractionation requires a substantial increase in NAT-tested donations. At the same time, the demand for NAT-tested red cells remains unchanged. Therefore, each IRC Blood Center must assess how to balance plasma preparation for fractionation with the production of other blood components. Another key consideration is the use of discriminatory testing. Although NAT-positive donations are generally discarded and not used for transfusion, discriminatory testing—which identifies the specific pathogen—is essential for compiling epidemiological data required in the Plasma Master File. To meet this need, IRC Blood Centers are working to implement testing consolidation strategies that ensure efficiency and effectiveness.
2. System Information Management (SIM)
The Indonesian Red Cross utilizes a SIM platform called SIMDONDAR. While this system already integrates essential donor and testing data, modifications were necessary to support plasma preparation for fractionation.
a. Epidemiological Data The Plasma Master File requires detailed epidemiological data, including the prevalence of TTIs. Previously, prevalence was calculated based on all donations. Now, data must be separated into two categories: prevalence among first-time donors and prevalence among repeat donors.2
b.Look Back While reactive donors are typically contacted for follow-up, their previous donation history is often not analyzed—possibly due to the low frequency of blood donation in Indonesia, where many donors give blood only once per year. Using SIM allows blood centers to track and analyze past donations more effectively, supporting more comprehensive donor management and surveillance3.
Shipment to the Fractionator The first shipment of plasma to the appointed fractionator took place in March 2025, with contributions from three IRC Blood Centers totaling 1,058 liters. Subsequent shipments were made in July and September. As of September 2025, approximately 6,000 liters of plasma have been sent for fractionation.
Summary Establishing a reliable plasma supply chain for fractionation requires extensive preparation and strong commitment from all stakeholders. The Indonesian Red Cross remains dedicated to improving the quality of blood services—not only in terms of blood products for transfusion, but also in the development of high-quality plasma for fractionation. This initiative represents a critical step toward national health resilience and medical self-sufficiency.
References
- Balai Besar POM di Surabaya. Laporan Kinerja 2017 [Internet]. Surabaya; 2018. Available from: https://www.pom.go.id/storage/dat/20180426/Laporan%20Kinerja%202017%20BBPOM%20di%20Surabaya.pdf
- European Medicines Agency. Guideline on epidemiological data on blood transmissible infection. Amsterdam; 2017. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-epidemiological-data-blood-transmissible-infections-revision-1_en.pdf
- Burnouf T. Modern plasma fractionation. Transfusion medicine reviews. 2007 Apr 1;21(2):101-17.
