What are the main reasons that cause you to choose a continuous manufacturing vs. conventional?

Answer

There are several major drivers for implementing continuous bioprocessing. First of all, there are increasing needs for flexibility and speed to meet market demands. Continuous bioprocessing will allow the use of modular and smaller facilities with smaller and/or single-use bioreactors in order to meet rapidly changing and unpredictable market demands in diversified and segmented market places. Secondly, we expect that more low-volume biologics will need to be produced for personalized applications, in addition to historical demands for high volume biologics. Thirdly, both increased demands in emerging markets and introduction of biosimilars will increase competition and require lower COGs and therefore continuous processing could be used to address these various market factors. Thus, there are many advantages of continuous bioprocessing over conventional batch processing that should be considered including:

• A universal continuous platform for manufacturing could be developed for both stable and liable products
• Ability to achieve high cell concentration, cell viability and volumetric productivity
• Steady state operation that provides consistent product quality; low residence times
• Compatibility with the principles of QbD and manufacturability
• Multiple Operational advantages
  • Simplified process flow & logistics, high operational flexibility
  • Small equipment and facility footprint and lower initial capital investment
  • Modular architecture providing fast technology transfer
  • Minimal scale-up or potentially utilizing same scale for development, clinical and commercial manufacturing.
  • Smaller facility footprint and modular nature allows for “scale-out” instead of “scale-up” manufacturing paradigm