While last year’s inaugural ISPE Biopharmaceutical Manufacturing Conference centered on how to address the expanding capacity needs given the unprecedented growth in the sector, this year’s event, held on December 4-6 in San Francisco, CA, took a step further with a focus on innovative operational and process development approaches and strategies to speed preparations toward launch readiness. Our Bosch Packaging Technology delegates returned from the event with the following key takeaways to report:
- The growing need for specialized medicines produced in small batches means that efficient manufacturing systems also need to be flexible and have short changeover times.
- The share of biopharmaceutical production conducted at CMOs/CDMOs continuing to rise, improving the agility (and quality) of CDMOs as strategic partners is a priority for the industry.
- Experienced equipment suppliers, such as Bosch, that can provide robust process know-how along with the hardware, can play a productive role in helping with FDA compliance in the CMO/CDMO sector.
- 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.
- Facilities of the future are likely to be all-SUT manufacturing plants with next generation design concepts: box-in-box, modular, etc. As recent examples illustrate, the era of no CIP infrastructure at all in facilities has arrived.