Table 3.
Plans for biological standardization by the participating countries.
| Countrya | Plans |
|---|---|
| Indonesia | Development of testing methods for PDMPs (2024–2026). |
| Development of testing methods for biosimilar products, such as Heparin injection, Epoetin alfa, and Filgrastim (2024–2028). | |
| Development of monocyte activation test as a replacement of rabbit pyrogen test (2025–2027). | |
| Development of biological reference standards (2025–2030). | |
| Korea | Improvement of the in-vivo potency assay for Botulinum toxin (2023). |
| Establishment of a national standard for anti-thrombin concentrate, 2nd (2023). | |
| Improvement of the potency assay for Bacillus Calmette-Guérin (BCG) vaccine (2023–2024). | |
| Development of alternative potency assays for haemorrhagic fever with renal syndrome vaccine (2023–2024). | |
| Development of monocyte activation tests as a replacement of rabbit pyrogen test (2023–2025). | |
| Improvement of quantitative assays for Meningococcal conjugate vaccine (2024–2025). | |
| Improvement of testing methods for PDMPs using analytical quality by design (2024–2026). | |
| Malaysia | Development of potency assays for Meningococcal (NPRA), Influenza, and Human papillomavirus vaccines (National Public Health Laboratory) (2023–2024). |
| Attainment of WHO GBT maturity level 4 for NRA assessment (2023). | |
| Philippines | Establishment of a Vaccine Laboratory (2024). |
| Attainment of WHO GBT maturity level 3 for NRA assessment (October 2023). | |
| Vietnam | Establishment of national standards for Rota, Rubella, Measles, Diphtheria, Tetanus, Haemophilus influenza type b, Typhoid, Japanese encephalitis (Beijing strain), Acellular pertussis, Inactivated Poliovirus, BCG, Rabies, Whole-cell pertussis, Hepatitis B recombinant, Recombinant Hepatitis B MC, and Nakayama Japanese encephalitis vaccines. |
a
Only countries that submitted information were included.