Pharmaceutical production

© Fraunhofer IPA

Enormous advances are being made in the personalized treatment of complex conditions through the use of biopharmaceuticals and, in recent times, ATMP. But the question is how can these methods be scaled in future to meet the large number of potential patients?

Against the background of personalized medicine, the production of pharmaceutical products is facing major challenges and changes. This trend is now coming to a head in the field of ATMP, since products in this area must be individually manufactured for each patient.

Production costs need to be significantly reduced and production methods must undergo major optimization and standardization.

We are implementing the principle of decentralized matrix production for individual drugs. For example, cell and gene therapy based on standardized processes are being produced in the form of closed, fully automated, monitored and transferable mini-factories. The platforms can grow alongside a process, with no limits on their scalability. At the same time, “GMP-in-a-box” concepts enable the necessary infrastructure to be minimized without impacting safety.

  • How can drugs be produced individually in a wide range of variants at the quality and cost of mass production?
  • How can production infrastructure be designed with optimal efficiency so that a high level of utilization is achieved?
  • How can important quality characteristics be included inline or online so that work is reduced for offline quality control?
  • What technical aids can be used to ensure that preclinical manufacturing processes are transferred to clinical approval as quickly and cost-effectively as possible?
  • Which process tracking parameters can be tracked as a basis for developing new, future processes more quickly and efficiently?
  • How can personalized and affordable medicine become a reality through efficient laboratory processes?
  • How can personalized treatment be made generally available through cost-effective manufacturing processes and automation?
  • How can technical and biological systems interact in an optimal way, and how can they be used?
  • How can the development of drugs and diagnostic products, as well as research into these fields, be accelerated through automation, digitalization, adapted flexible processes and user integration?
    • Studies and design of production systems (green field planning)
    • Process and workflow evaluation and testing
    • Requirements analysis and solution design 
    • Automation potential analysis
    • Development of sensor technology for process monitoring
    • Development of connectors for safe, sterile transfer
    • Regulatory compliance
    • Development and construction of prototypes
    • Solution validation and verification
    • Partnering and formation of interest groups in the ADAPT Lab (automated and decentralized ATMP production technologies)
    • Planning and design of systems
    • Implementation of systems
    • Process adaptation and development, validation