In the end, it all comes down to manufacturing the drugs on a commercial scale. Many challenges have to be overcome. This year’s aseptic conference has dedicated two sessions to manufacturing case studies. The first of these contains three case studies with very different requirements that must be solved. What they have in common is that they will lead the way for the future:
1) How to introduce a lifesaving vaccine as fast as possible by finding the appropriate approach through all the stages of manufacturing.
2) The filling of high potent drugs into syringes where established processes like outside washing (of the vial) cannot be applied.
3) Embracing the diversity of packaging materials on a multi-purpose fill/finish line for many different kinds of ready-to-use containers.