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Process
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Services Details
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Unit Operation
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Technology Transfer
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Document transfer
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Process, formulation, analytical methods and quality standard
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Technical and compliance evaluation
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Evaluation of man-machine-material-method-environment-measurement;
Evaluation of process, formulation, analytical methods and quality standard.
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Technology transfer implementation
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Manufacturing process and analytical transfer
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Process validation
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1~3 engineeringbatchesto evaluate and confirm the process is robust.
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Plasmid Manufacturing
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E. colifermentation
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Preparation of fermentation system
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Seedcultivation, fed-batch fermentation
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Plasmid purification
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E. colicell harvesting and alkaline lysis
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Plasmid purification, impurities removal
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Plasmid linearization
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Single enzyme digestion
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Purification of linearized template plasmid
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mRNA DS Manufacturing
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mRNA synthesis
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In vitrotranscription (IVT) reaction
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mRNA purification
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DNA template removal
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mRNA purification, impurities removal
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mRNA buffer exchange
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Tangential flow filtration
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LNP DS Manufacturing
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LNP encapsulation
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Preparation of ethanol phase containing lipids
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Microfluidics technology
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Concentration and buffer exchange
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Tangential flow filtration
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