Bioprocess and Formulation Development

Rentschler delivers upstream process (USP) development for cell cultivation and downstream process (DSP) development for protein purification as well as formulation development.

• Process development
  – Platform & customized
  – High cell density & high titer
  – Batch, fed-batch, continuous & perfusion
  – Non-GMP production up to 250 L
• Scale-up and process transfer to production scale
• Process characterization, scale-down modelling and validation
• Transfer and optimization of client’s bioprocesses
• Liquid formulation development
• Preliminary protein characterization including stress-degradation
• Evaluation of indicative analytical methods
• Parameter screening (pH, buffers, ionic strenghts, excipients, surfactants)