Suspension Culture Bioreactors for FMD Vaccine Production
Jan.15.2026
A leading manufacturer of veterinary biologics specializes in the R&D and large-scale production of Foot-and-Mouth Disease (FMD) vaccines. To increase production capacity and ensure product quality stability, the company introduced our series of suspension culture bioreactors and supporting upstream equipment, establishing a complete production line from cell proliferation to virus purification.
Core Equipment Configuration
The project's core equipment includes one 80L, one 300L, one 1000L, and one 2000L suspension bioreactor, supplemented by four 5000L suspension bioreactors. The system is paired with customized cell seeding systems, media preparation and sterilization systems, and online monitoring and control systems. This comprehensive setup is fully optimized for the suspension culture of BHK-21 cells and the propagation of the FMD virus.
Production Process
The production process follows a core workflow: "Seed Expansion — Viral Inoculation & Replication — Harvest & Purification."
1.Cell Seed Expansion: BHK-21 cells are revived and expanded in an 80L bioreactor. The supporting equipment precisely controls temperature (37℃), pH (7.2-7.4), and dissolved oxygen (60%-80%) to ensure high initial cell viability.
2.Scale-Up Culture: Once the cell density reaches 1.0×10⁶ cells/mL, the culture is transferred aseptically to 300L, 1000L, and finally 2000L bioreactors. During each scale-up stage, online cell counting and metabolite monitoring modules dynamically adjust the feeding strategy, enabling stable, high-density proliferation. The process culminates in the 2000L reactor, where cell densities exceed 5.0×10⁶ cells/mL.
3.Viral Inoculation & Harvest: After expansion, the cell culture is inoculated into four 5000L bioreactors along with the FMD virus seed. The bioreactor system precisely regulates agitation speed and aeration to prevent cell shear damage while ensuring sufficient virus-cell contact. Viral titer is monitored in real-time. When the titer peaks at 10⁷ TCID₅₀/mL, the culture is terminated, and the viral supernatant is harvested.
4.Downstream Processing: The harvested viral fluid undergoes inactivation, purification, and other downstream processes to produce the final FMD vaccine product that meets national standards.
Results
The implementation of this system has achieved large-scale, automated, and precise control of FMD vaccine production. Compared to traditional processes:
Capacity Increased: Production capacity has increased by more than 4 times.
Stability Enhanced: The cell culture success rate remains above 98%, and the batch-to-batch variation of viral titer is controlled within ±5%.
Safety Improved: Manual labor intensity and contamination risks have been significantly reduced.
This system provides core equipment support for the enterprise to achieve efficient and high-quality vaccine production.
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