Next generation pharmaceutical processes and technology solutions – and the further development of existing and well-known processes – bring both challenges and opportunities and have implications for new and existing facilities alike.
The main challenges relate to the smaller product volumes inherent in many new products and to smaller batch sizes for existing and new products. This calls for many of the facilities designed for single product manufacturing to be transformed into multi-product facilities. Still, large-scale production facilities will continue to be built or rebuilt; adapted to the new generation’s requirements but with production technologies sized to the large volumes.
In addition, current requirements and expectations towards areas such as cleaning, prevention of cross-contamination and containment of high-potency ingredients are driving upgrades of aging facilities. New requirements and manufacturing regulations create daily problems with compliance, deviations and sometimes even batch failures. Many legacy facilities are dealing with a high number of quality deviations and some experience regulatory issues when inspections find areas of the facility outdated.
On the opportunity side, single-use systems are spreading from biotech into other areas of pharmaceutical manufacturing, enabling more efficient or flexible production. Continuous manufacturing is also gaining ground. This is driven by US FDA’s active encouragement towards innovation and application of emerging technologies for better manufacturing solutions that can prevent or avoid many of the quality problems of the past.