While last year’s ISPE Biopharmaceutical Manufacturing Conference centered on innovative operational and process development approaches and strategies to speed preparations toward launch readiness, this year’s event, held on December 4-7 in Huntington Beach, CA, focused on the quickly evolving science of biologics manufacturing for new modalities such as those involved in advanced therapeutic medicinal products including CAR-T, cell and gene therapy, and personalized cancer vaccines. Our Bosch Packaging Technology delegates returned from the event with the following key takeaways to report:
- Automation for the manufacture of most advanced therapeutic medicinal products is still in early stages of development. Current solutions provide only semi-automation and are suitable for a limited range of applications.
- The growth in the share of biopharmaceutical production of advanced therapies conducted at CDMOs has slowed due to capacity constraints. Many biopharma startups in this space, unable to secure manufacturing capacity at CDMOs, are building their own facilities on accelerated schedules using brownfields or erecting prefabricated modular facilities.
- Research on options to provide GMP manufacturing at the point of care for many of these therapies is starting, but is likely to take decades before bearing fruit.
- The considerations for process replication are very different for the new cell and gene therapy products arriving on the market and automation is particularly attractive in this area. Aseptic technique/processing is crucial in these applications since filtration is not applicable to ensure sterility.
- The facilities of the future have arrived as advertised: all-SUT manufacturing plants with next generation design concepts: box-in-box, modular with built-in process flexibility, etc.