Leveraging efficiency from cell line development to clinical manufacturing of monoclonal antibodies

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The number of FDA-approved monoclonal antibodies (mAbs) continues to grow, while those in late-stage development rose more than 30% between 2021 and 2022. Given the relative value of being first to market, biopharmaceutical companies are looking to shrink the 10 or more years it usually takes for a biologic candidate to progress from drug discovery to regulatory approval.

Increase speed, reduce risk and maintain quality of mAbs by partnering with a CDMO that has a comprehensive program for moving from discovery to clinical batches of a new biologic.

  • Rapid antibody discovery process
  • Cell line development using CHO-GSN℠ platform
  • Cell bank generation and characterization with Solentim® VIPS™
  • Upstream process development using Sartorius® Ambr® 15 Cell Culture Bioreactor System for optimized culture conditions
  • Downstream process development
  • Drug product formulation development and manufacturing
  • Identifying critical quality attributes (CQAs)
  • Quality systems at Curia
  • Specializing in First-to-Human manufacturing support

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