Large Scale Bioprocessing Suite

Our latest cleanroom expansion, Large Scale Bioprocessing, allows us to expand our manufacturing scale to better meet customer needs. This cleanroom is nearly 50% larger than a standard cleanroom and increases our scale up to three times in some product areas. With multiple reach-in incubators for adherent culture and bioreactors for increased suspension culture capacity, Waisman is well situated to meet the demands of projects that require larger cell culture capacity.

Special Features:

  • ISO Class 7 (<352,000 particles/m3, 0.5 µm particles) cleanroom
  • Class II Type B3 biosafety cabinet
  • Critical room parameters and equipment monitored by Rees Equipment Monitoring System

Process Scale-Up Opportunities:

  • Capacity for up to three reach-in incubators increases adherent cell culture process scale
    Example: Mesenchymal Stromal Cell lots ≥ 5 billion cells
  • Planned expansion Capacity for  250L single-use bioreactor technology improving cell culture yield 5x over current 50L capacity
    Example: Increased capacity for recombinant vaccine antigens and therapeutic proteins including monoclonal antibodies

Select Equipment:

  • Single use bioreactor (50L, 250L)
  • Multiple Reach-In incubators for adherent cell culture
  • Cobe Cell Processor
  • Thermo Fisher RC3BP Plus Centrifuge
  • Scalable Liquid Chromatography (LC) systems including BPG columns
  • Scalable single-use Tangential Flow Filtration (TFF) systems