Return to Process Development Services

We apply Best Practices in Process Development when helping our clients establish scalable and cost effective manufacturing processes for their autologous or allogeneic cellular therapies. Lonza works with therapeutic companies to understand their current manufacturing process, the cell and product characteristics that are critical to maintain during process development, as well as their target cost of goods (CoGs). We then perform a scalability evaluation and develop process models to help guide decision making towards scalable, cost efficient processes that can be manufactured at the scales required for mid-to-late stage clinical trials as well as during the commercial introduction of this new class of therapies.

The following are the technology platforms and services that we provide:

Allogeneic – Scale-up Processes

  • Process modeling for scalability, streamlining, and CoGs and capacity modeling
  • Tissue acquisition and cell isolation techniques
  • Media optimization and customization, feed strategies, and closed-system disposables development
  • Cell-banking strategy
  • High volume, closed system 10-layer seeding, culture, and passaging processes
  • 10-layer to 40-layer or 120-layer Hyperstack scale-up
  • 10-layer to stirred-tank microcarrier-based bioreactor scale-up
  • Closed system and scalable volume reduction and washing
    • Therapeutic cell Tangential Flow Filtration (TFF)
    • kSep continuous counterflow centrifugation
  • Cryopreservation formulation development and closed system formulation processes
  • High volume Aseptic vial filling
  • Scalable controlled rate freezing

Autologous/Patient-specific

  • Scale-out Processes Process modeling for scalability, streamlining, and CoGs and capacity modeling
  • Tissue acquisition and cell isolation techniques
  • Media optimizaion and customization, feed strategies, and closed-system disposables development
  • Bag culture systems, GREX and Wave bioreactor culture system evaluation and comparison Scale-out of adherent cell culture processes
  • Closed system volume reduction and washing
    • Therapeutic cell Tangential Flow Filtration (TFF)
    • kSep continuous counterflow centrifugation
  • Biopreservation optimization
    • Non-frozen shelf-life extension formulation optimization
    • Cryopreservation formulation development and controlled rate freezing
    • Closed system formulation processes
  • Vial and bag final container filling