Gene Therapy Products Facility

Features:

• Design of the first ever manufacturing facility for Gene Therapy products
• Processes include cell culture, harvest, inactivation, formulation and filling
• Requirement for several independent suites. The initial design has two production suites capable of independent operation. Subsequently additional suites can be added rapidly to meet the following possible requirements:
  • to meet increasing demand
  • to enable several products to be developed simultaneously
  • for new organisms that need to be kept separate
  • for production based on other technologies
• Design and layout to meet process, cGMP and containment requirements
• Production technology involves complex multi-step operations requiring the highest level of facility standards
• Production suites contain all equipment for the specified product. Clean rooms to Class 100 and Biosafety cabinets, are used for initial stages, with barrier technology used to optimise operations in later processes