The pharmaceutical industry develops new and more efficient Active Pharmaceutical Ingredients (API’s) in their Research and Development centers. Time-to-Market is a key requirement for new pharmaceutical products, in particular for new API products. Fast and reliable scale-up methods from laboratory to pilot scale and transfer to commercial production are essential for the successful launch and implementation of new pharmaceutical products as well for the increase of capacity of existing production facilities. Pre-designed and flexible plant concepts enable fast and flexible API production under cGMP conditions.
The presentation will give an overview on a fast and flexible design approach for both chemical and biotech API projects. Pre-designed and proven plant modules, layout typicals and facility structures are applied to accomplish rapid and ‘first-time-right’ plant conceptualization. The modular approach for both process and facility will be outlined with the help of visual examples for the different modular levels and project objectives.