Quality by Design projects are an essential part of the facility of the future. Which successful projects do you know?
Moelgaard: There are examples of successful QbD projects, but the transition to Quality by Design product development and manufacturing simply takes more time than originally expected, when for example the ICH Q8 Guideline to Pharmaceutical development was developed. Some of the Big Pharma companies have been very active while many small and midsized companies are behind, especially in Europe.
Dedicated Manufacturing – Just one of many Aspects in the “Facilities of the Future”
And what is the matter with dedicated manufacturing?
Moelgaard: Dedicated manufacturing is one of many aspects in the “Facilities of the Future” initiative and will be an important decision factor, however it must be seen in combination with the need for flexibility in the future and the ability to comply with the regulatory requirements.
Continuous manufacturing will become more important. Which stages do you have reached?
Moelgaard: I know the suppliers that have developed continuous solutions for pharmaceutical processing have seen a very broad interest in their solution, but not as overall facilities yet. It comes in stepwise. Continuous formulation and blending, longer batch runs in bioprocessing, campaign manufacturing in aseptic processing etc. I think the first big step is to set a strategy rather than just shopping for a number of solutions. Continuous manufacturing is not a universal solution, but the good news is that the regulators support it and that for example the new FDA guidance on process validation and the EMA draft guidance remove some of the barriers for adoption.
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