Process Characterization
For later stages of clinical development, we offer a fully-integrated package for process characterization and validation based on regulatory and cGMP guidelines to ensure the success of your BLA submission. Intellective Bio’s package includes:
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Risk assessment of process parameters
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Scale-down model establishment
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Design space study on critical process parameters
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Viral Clearance Validation
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Process Characterization Studies
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In-process hold time studies
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Impurity challenge studies、Risk Assessment
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Material compatibility studies
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Validation of analytical methods
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Process validation with integrated process control strategy
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Consecutive manufacturing of validation (PPQ) batches
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CMC document authoring in CTD format
