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Clarivate sell "Cortellis CMC Intelligence™"

Basic Information

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22
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3.8(56)

Trade Type

Sell

Service Name

Cortellis CMC Intelligence™

Service Provider(s)

Specifications

  • Expression System: Produced using mammalian (e.g. CHO) or microbial (e.g. E. coli/yeast) expression systems as appropriate to the specific molecule
  • Purity: Certified purity meeting pharmacopeial or in-house specification, confirmed by Certificate of Analysis issued with each batch
  • Formulation Type: Formulation type and format determined per project/client specification (e.g. liquid, lyophilized, solid oral)
  • Storage Condition: Store at 2–8°C (refrigerated), protected from light

Other Information

Additional Description:

Cortellis CMC Intelligence is an extensive database detailing the granular chemistry, manufacturing and controls (CMC) requirements needed for the initial global registration of both small-molecule and biologic drugs. By consolidating these regulatory data points, it helps sponsors streamline registration filings, reduce the risk of approval delays, and improve the likelihood of a favorable health authority review.
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