Biopharmaceutical Development

Biopharma-Development

Kemwell’s integrated cross-functional project team comprise of  process development and analytical development scientists who work closely together, leading to excellent product and process understanding.

Process Development

  • Upstream development
  • Downstream development
  • Process chracterization
  • Scale-up studies

Key Features

  • Mammalian cell culture process development
  • Well-defined purification schemes with clearly establishedcapabilities for each process step
  • Establishment of scale-down models and process charazterization (employing Design of Experiments approach) to support at scale validation

Analytical

  • Method development
  • Method validation
  • Reference standard characterization
  • Stability studies

Key Features

  • Method development and qualification
  • ICH based method validation, lot release testing, analyticalcharacterization and stability studies to support drugsubstance and drug product
  • Establishment of reference standard based on regulatory requirements

Formulation Development

  • Preformulation
  • Liq. And Lyo. Formulations
  • Lyo. Cycle development

Key Features

  • Pre-formulation studies using various biophysical techniques
  • Formulation development to support liquid and lyophilized formulations