The pharmaceutical and biotechnology products currently under development or being commercialized are specific and personalized in nature. Given this targeted nature the value of these products are high and batch sizes are small. This brings new manufacturing challenges to aseptic fill-finish operations where traditional approaches are not meeting the flexibility, yield or efficiency these products require. To overcome these challenges new flexible solutions are providing manufacturing options for these small batch aseptic filling applications.
One of the most significant technology trends being used for drug product manufacturing today are flexible fill-finish systems that process multiple container options using a common aseptic filling machine. The next generation drug products are more targeted and patient specific by nature causing batch sizes to be much smaller than the traditional mass produced sterile drugs manufactured historically. This paradigm shift paves the way for new solutions that are geared toward manufacturing flexibility. The key to these adaptive aseptic filling technologies is efficient production of high value, high mix (multiple product skews) products irrespective of the final presentation or parenteral container.