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BETTER MANUFACTURING NEEDS BIGGER THINKING

The Drivers for Modernizing Pharmaceutical Manufacturing

  • Process and material understanding
  • QA / QC strategy
  • Real-time release testing
  • Predictive modeling
  • Regulatory alignment
  • Economic alignment
  • Human resource/expertise development

Our Approach to Continuous Manufacturing Development:

  • An interdisciplinary team of process, pharmaceutical and chemical engineers and researchers
  • A diverse partner matrix consisting of pharma, technology/equipment providers, and academic/scientific collaborators
  • A platform for pre-competitive information exchange and networking
  • Flexible intellectual property rights (IPR) arrangements to enable a agile and focused exploration of specific interest

Benefits and Expected Outcomes

  • Low financial risks to explore new technological options and applications
  • Access to RCPE’s long-term experience with continuous and advanced manufacturing, PAT, process control, and predictive modeling
  • Exploitation of RCPE’s extensive experience in the advanced manufacturing and (in-line and off-line) characterization
  • Access to the most advanced AI-based dissolution prediction models
  • Access to the regular ECCPM-organized conferences
  • Examination of the impact of continuous manufacturing routes on costs (production, materials, footprint, etc.), efficiency and yield
  • Implementation of concepts for integrated quality control strategies
  • Utilization of continuous manufacturing knowledge and experience
  • Access to consolidated scientific expertise (e.g., simulation, control and process knowhow, RTRT-PAT, and formulation development)
  • Access to equipment and instrumentation suppliers
  • Access to an international and focused network