Chemistry Manufacturing & Controls

bdp experts can guide you through all aspects of CMC development

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Process Development & Optimization

  • Cell line development
  • Cell bank manufacture and testing (MCB, WCB)
  • Process development (upstream & downstream)
  • Equipment & materials
  • CMO selection
  • Viral clearance
  • Process control strategy
  • Quality by Design (QbD / DOE)
  • Scale-up and site transfer
  • Process validation / PPQ
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Analytical & Characterization

  • Analytical method development
  • Product & impurities characterization
  • Cell line characterization
  • Comparability & biosimilarity
  • Reference standards
  • Critical Quality Attributes (CQA)
  • Troubleshooting
  • Method qualification & validation
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Formulation & Stability

  • Formulation development
  • Stability studies
  • Forced degradation
  • Compatibility studies
  • Primary & secondary packaging
  • Prefilled syringes
  • Complex dosage forms