The always-essential 2019 ISPE Aseptic Conference was held in North Bethesda, MD and we were there to assess the trends, check out the leading-edge sessions, and share lessons with industry leaders. Read on to find out what we found interesting or compare with your notes, if you attended.
This annual conference brings together industry and regulatory leaders in the aseptic processing field for two days of learning and discussion. The 2019 breakout sessions followed a similar pattern to last year’s event: Barrier, Aseptic, and Containment. Particularly interesting to us was the keynote address by FDA/CDER Director Richard Friedman who commented, “GMP is good GBP, which equals good business practice.” In our view, nearly all talks this year could be unified into a “Facility of the Future” concept that is anchored on patient safety, while gaining added flexibility for personalized medicine.
The Facility of the Future
This year, there were some engaging presentations and discussions regarding emerging trends that will create sterile manufacturing facilities of the future. The concept is built upon the collective design choices and most advanced aseptic technology available to produce the safest possible product. These technologies include ready to use components, single use solutions, isolators, and robotic applications on filling lines to create more reliable and robust processes. What about legacy facilities? The sessions on “Advanced Technologies for Legacy and Future Facilities” and “Facility Upgrades and Expansion” covered various approaches for transitioning to these newer technologies. Retrofitting can be a time consuming and costly endeavor, however, for the sake of the patient this industry will continue to improve and create the facility of the future.
Removing the Human
The use of robotics was a frequent topic at this year’s conference, as it has been in the past. The perspective from several leading engineering companies was presented followed by an interactive panel and audience discussion. It was clear from the participation in this session and others that removing the human further from the process is a trend that continues to grow and gain acceptance. Robotic applications can vary greatly and the panelists were able to illustrate this point. In addition, there were several case studies presented in other sessions at the conference that highlighted a range of applications, including a few on robotic gloveless filling machines.
Rise in Personalized Medicine
Cell and gene therapy products are a fast growing segment of the pharmaceutical market where manufacturing operations can be complex and challenging. Extensive handling, unique processes, timing, and small batch sizes are characteristics of these types of products. Case studies from several companies who are overcoming these challenges (e.g. implementation of robotics) were presented in the “Aseptic Cell and Gene Therapy” session. Blockbuster drugs will continue to exist, but products for targeted patient populations is an exciting development that will drive manufacturers to increase adaptation of technology or fall behind. Continuing to focus on high value, small-volume drugs is a great fit for the ISPE subject matter presented at the conference. Innovative products require innovative technologies and this pushes advancements in barrier and containment systems, and application of robotics.
Argonaut and the Facility of the Future
It was exciting to see so much discussion on how to bring the Facility of the Future beyond concept to actual practice. Argonaut is introducing a drug product fill-finish line in 2019, designed on the same underlying concepts. Our VarioSys® line is a custom combination of Bausch+Ströbel filling equipment and SKAN isolator technology, designed to maximize product yield and reduce risk. We made a conscious choice to use state-of-the-art equipment, single-use technology, and ready-to-use nested vials for our line. The Argonaut drug product manufacturing facility is the Facility of the Future, today.
If you want your drug product aseptically filled on a state-of-the art line, contact Argonaut to learn more or call 888-834-8892.