• 万向娱乐

  • Single Use Wave Bioreactor

    The system adopts the design concept of distributed control system,which can meet the process requirements of multi-level scale up.Users can configure flexibly.

    We can provide a complete single-use production process solution.

    The system adopts intelligent sensors and PID control strategies to meet the precise regulation of dissolved oxygen and pH for different products and different process stages.

    The data is saved in the database,which meets the basic requirements of computerized management and data integrity in FDA 21PART 11.

    The system provides functions such as multi-level user management,operation records, electronic signatures,formula management,and data reports;

    The DCS(distributed control system)design increases the system compactness and realizes digital interconnection and data sharing.

    Specification

    Single Use Wave Bioreactor

    Performance WAVE Mixing tank Spinner Flask/Shake Flask
    Comparison
    Mixed mode Wavy Immersion stirring Swinging vortex type
    Shear force Extremely low High Low
    Oxygen transfer area High Middle Low
    Oxygen transmission mode Surface wave type oxygen transfer Bubbling oxygen transfer Surface oxygen transfer
    Oxygen transmission effect High Middle Low
    Dissolved oxygen level High Middle Low
    Gas flow meter High precision mass flowmeter Cheap rotameter,low accuracy NA
    Cell density(cell/mL) High density,generally >106-7 T CELL perfusion 1~2x107
    Insect cell perfusion >108    		 106-7 Low density,generally1055-6
    Cross contamination risk NA High High
    Infection probability Low Middle High
    Cluture parameter control Automatic feedback regulation pH,DO,Temp, CO₂% Automatic feedback regulation pH,
    DO,Temp, CO₂%    		 NA
    Weighing perfusion Integrated weighing and automatic filling NA NA
    Working volume Flexible,10-100% Inflexible,50-100% Inflexible ，10-30%
    Foam Positive pressure,not easy to produce foam Large amount of foam will be 
    generated,and a defoamer is required    		 Less foam
    Operation Easy A lot of experience needed Difficult to scale up applicable
    Microcarrier technology applicable applicable NA
    Micro carrier ball It can be performed directly in the Wave without a digestion reactor The operation is complicated and needs
    to be transferred to the digestion reactor.    		 /
    Training environment Ordinary Clean room Clean room
    mobility Yes Fixed Yes
    Comparison of process scale-up production
    Scale up mode 00mL-100L requires only one WAVE,
    or multiple 100L WAVES for parallel scale up    		 Three to four seed tanks are required
    for step by step to above 1000L.    		 Large amount of spinner
    flasks/shake flasks
    Scale up Easy,fine tune parameters High risk,need to explore again Difficult to scale up
    Equipment cost Low High Low
    Computer real-time monitoring Yes Yes No
    Multi variety R&D and
    production platform    		 Sterile closed piped platform
    enables quick change of cell
    bags for easy authentication.    		 Difficult to clean and certificate,
    and cross contamination among varieties    		 Difficulties in
    managing certification
    Equipment maintenance cost Low High Low
    Cost of new workshop 1(Class 10000 trolley room) 10(Class 100 medium workshop) 4(Class 10000 workshop)
    Expansion and utilization
    of existing workshops    		 No reconstruction required Redesign and build Extension
    Workshop construction Short cycle and low cost Long cycle and high cost Long cycle and high cost
    Production cycle Short Long Short
    Fixed stainless steel pipe connection No Yes No
    Production flexibility High Low Low
    Auxiliary production cycle Short Long Long
    Plant utilization rate High Low Low
    SIP steam No Much No
    WFI dosage Very little Much Middle
    Cleaning and maintenance cost Extremely low Very high High
    Consumables Cell bags(Cell bags of the same cells can be reused) Mixing energy consumption,
    pipe sealing,valve gasket,
    cleaning solution,WFl,SIP steam    		 Cell flasks,cleaning
    solutions,WFI and
    extensive manual work

     

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