This dedicated industrial bioreactor is purpose-built for high-density fermentation of engineered E. coli strains to amplify plasmid DNA (pDNA), serving as the core upstream equipment for mRNA vaccine raw material manufacturing, also applicable to gene therapy vectors and DNA vaccine plasmid batch production.
The tank body and wetted piping adopt electropolished 316L stainless steel with seamless orbital welding, supporting fully automated SIP in-place sterilization and CIP cleaning, and completes full E&L extractables & leachables verification, fully compliant with biopharma cGMP standards for plasmid raw material production. The optimized stirring system and layered sparger design deliver excellent oxygen mass transfer capacity, perfectly matching the high oxygen demand of E. coli logarithmic growth phase, effectively avoiding oxygen limitation that restricts biomass accumulation and plasmid copy number elevation.
Equipped with high-precision real-time sensors for dissolved oxygen, pH, temperature, tank pressure, exhaust gas, foam level and feed flow rate, the system realizes closed-loop automatic control of glucose feeding, ammonia supplementation and antifoam addition. Customizable fed-batch fermentation strategies stably control specific growth rate, suppress acetate byproduct accumulation, significantly improve cell dry weight and final plasmid yield per liter.
The control system follows ISA-88 batch automation specifications, storing multiple mature plasmid fermentation recipes, enabling unattended full-cycle operation, continuous data trending and complete audit trail recording, meeting data integrity requirements for regulatory filing of mRNA vaccine starting materials. Consistent kLa and geometric scaling design ensures reliable process transfer from lab strain amplification, pilot batch verification to commercial large-scale plasmid mass production.
The equipment can be matched with subsequent lysis, clarification, chromatography purification and ultrafiltration systems to form a complete pDNA production workflow. It provides stable, scalable upstream hardware support for mRNA vaccine industrialization, gene therapy plasmid manufacturing and cGMP-grade plasmid raw material supply projects.
