The 2019 ISPE Aseptic Conference has ended but there is still a great opportunity to take advantage of the education sessions that took place during the conference by purchasing the recorded sessions package. This package includes 6 education sessions totaling 8 hours of dynamic content.
In this opening Keynote Session, Rick Friedman from FDA’s Office of Manufacturing Quality shares his perspective of the state of aseptic processing, providing insights on the very latest findings and learnings.
The State of Aseptic Processing: Current Findings and Learnings
Regulatory and Occupational Safety as well as Cleaning and Cross Contamination requirements for aseptic toxic/high potent substances are covered during this session.
Combined products like ADCs (Antibody Drug Conjugates) require PDE (Permitted Daily Exposure) of low nanograms per day level. This session will include strategies to avoid cross contamination in shared facilities and protect operators.
According to industry projections, by 2025 every other new Biopharma Product will be considered a highly potent/toxic product. Smaller batches, personalized medicine, and a high demand to prevent cross contamination will be the challenges for aseptic processing in the future.
This session will cover different case studies on high potent aseptic fill & finish. Modular and easy to change technologies from the view of a CMO will round out the session.
This industry panel discussion session begins with short, five-minute presentations from leading engineering companies followed by a moderated discussion. The discussion centers around lessons learned and the future outlook of robotics in aseptic manufacturing major installation projects, retrofitting of existing lines, and possibilities and limits of the use of robots, and robots versus simple automation.
The European Medicines Agency (EMA) issued a draft version of Annex 1 for discussion in December 2017. As this guideline, once approved, applies to all manufacturing in Europe, as well as all PIC/S (Pharmaceutical Inspection Co-operation Scheme) countries and for all products imported to Europe, it has a huge impact on industry. ISPE, under Jean-Francois’ leadership, submitted consolidated industry comments to EMA.
In this breakfast session, the hot topics from the draft Annex 1 and their implications for industry will be discussed. Examples include: contamination control strategy, post-sterilisation-pre-use-integrity testing of sterilizing filters and H2O2 decontamination processes.
High Potent/Toxic aseptic processing and facility design is a very complex interaction between the equipment, room, airlocks, utilities, cleaning and waste handling. During this session Automated Solutions, Isolator Technology, and design challenges for a new oncology products facility will be presented.
The recorded sessions package includes all 6 education sessions displayed above, totaling 8 hours of dynamic content.