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Oligonucleotides process development
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Raw material selection
Chemical modification and conjugation process
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Process development and validation
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Formulation and establishment of quality standard
Impurities study
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Raw material testing
Structure confirmation of the API
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Quality control of the process
Stability study
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Quality test
Reference preparation and calibration
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Analytical method development, transfer and validation
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Analytical method development
Method transfer and validation
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Sequence
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CMC material support for IND application
NDA application material support
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