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Evolution in Aseptic Processing: Flexible and Reliable Solutions

Jörg Zimmermann
Evolution in Aseptic Processing: Flexible and Reliable Solutions

How do we best design a production facility for advance therapeutic medicinal products (ATMPs)? How about high-potent products that need to be sterile? And what are the latest developments in Barrier/Isolator technology? We will try to answer all these questions during the 2020 ISPE Aseptic Conference on 2 – 3 March 2020.

For the 2020 ISPE Aseptic Conference, we chose the following theme: “Evolution in Aseptic Processing: Flexible and Reliable Solutions.”

David Doleski
Head of Global Quality Audit and External Engagement

Both conference days will open with a keynote address, one from FDA, one from the pharmaceutical industry. For the industry keynote, we were fortunate to recruit David Doleski from Sanofi. David has been working for the FDA for over 25 years before joining Sanofi. As the Head of Compliance, Biologics at Sanofi, he can now give us insights into how his professional change has also changed his view on some of the current hot topics.

Speakers from pharmaceutical companies such as Bayer, Gilead, Teva, Fresenius-Kabi, GSK, Kite, Hofmann-LaRoche, and many more will be giving insights into their facility designs, the operational aspects, pitfalls and lessons learned from state-of-the art manufacturing facilities. They will be supported by representatives from machine manufacturers and engineering companies so that attendees get the full picture. There will be a good mix of basic learning and advanced presentations so that young professionals and people new to the industry, as well as veterans who need very special questions answered will profit equally.

Advanced Therapeutic Medicinal Products, ATMPs are a recent innovation in the industry and provide some interesting challenges: individualized/personalized medicines mean smallest batch sizes, down to single units. Keeping the high standards of aseptic operations currently established, including quality testing require new concepts in building fill-finish operations. Additional challenges are presented in that these products are often live-cell-based or are formulated in live-virus vector-systems. An entire session will be devoted to these topics.

Robots for transfers have been used for several years in aseptic fill-finish operations, but with the recent advancements in the technology, the applications go beyond pure transfers and explore tasks like robotized environmental monitoring and other new, innovative uses. Some automated lines in isolators go so far as eliminating the gloves, so the process needs to be even smoother as no interventions are possible. Several case studies will be presented on the use of robots in clean-rooms, a topic that will again be picked up in the panel-discussion.

Small scale and clinical manufacturing have different requirements compared to full-scale, commercial manufacturing, but need to fulfill the same standards concerning aseptic handling. A prime example of this are the compounding pharmacies, academic institutions and hospitals. A session will look more closely at the challenges faced for these operators and will explore the solutions that they found.

During the conference, there will be plenty of opportunities for participants to exchange and network, including the popular small group workshop sessions. In these workshops, attendees will be able to discuss problems they are facing in their everyday work, and frequently will find new ideas and solutions in the discussion with their peers. We have seen real, long lasting friendships develop from these first encounters.

As we speak, a new survey on the design and use of RABS and isolators in the industry is being conducted. The aim is to get a representative view on the state of the industry in 2020. The results of the survey will be presented for the first time in a breakfast session, sponsored by the ISPE Women in Pharma® Networking Group .

The culmination of the conference will again be the interactive regulatory panel, with a number of representatives from FDA on the podium, including many of our veteran FDA experts. They will be answering questions live from the audience using our audience polling system. The FDA representatives come from different branches of the agency, so no question will go unanswered. In the past, we have seen lively and open discussions around everything from cleanroom designs, disposable systems, media fill/process simulation trials, artificial intelligence and many more.

This is the one pharma conference that you simply cannot miss in 2020! Year after year this conference continues to grow and we want you to be a part of it in 2020.

Looking forward to seeing you there.