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Highly Potent/Toxic Products - New Generation of Combined Products

Richard Denk
2018 ISPE Aseptic Conference

2018 ISPE Aseptic Conference

The annual ISPE Aseptic Conference continues to provide cutting-edge education in aseptic technology. The 2018 ISPE Aseptic Conference, 6 -7 March in Reston, VA, marks 27 years of providing information to ensure safe and reliable product supply while providing patient safety.

I’m very pleased to share that this year’s conference includes a new half-day track on highly potent/toxic aseptic products.

Highly Potent/Toxic Products are a new generation of combined products like ADCs (Antibody Drug Conjugates) or Cell, Immune, or Gene therapies found in Regenerative Medicine. This new generation of products requires more precautions during manufacturing and cleaning operations to protect human operators and prevent cross contamination in shared facilities. In the new Highly Potent/Toxic Aseptic Track, case study presentations will explore unique requirements and challenges related to product processing and industrial hygiene and provide a CMO perspective on manufacturing these products.

As part of the planning committee, I can share with confidence that the 2018 ISPE Aseptic Conference provides content-rich education sessions with thought-provoking dialogue and discussions you will not want to miss.

I am looking forward to attending the Aseptic Conference, as it helps me to expand my network, learn and benchmark from pharmaceutical industry leaders, and get an up-close and personal view of innovations that will shape the industry. Check back often over the next several weeks, as we’ll be sharing more about the 2018 ISPE Aseptic Conference.  I look forward to seeing you there.

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The 2018 ISPE Aseptic Conference will feature a keynote presentation from Robert Sausville, Director of Case Management, Office of Compliance and Biologics Quality, FDA/ CBER /QCBQ/DCM on "Aseptic Processing Points to Consider: After 30 Years of Pondering." The conference also features a first-time presentation of polling results from ISPE's 2017 Survey on Aging Facilities, a challenge for the majority of owners in this business.
Additional notable highlights include:

  • An all-star line-up of leading sterile manufacturers – A "Who's Who" of sterile manufacturers in 2018, including:  Abbvie, Alnylam, AstraZeneca, Bayer, Biogen, Bristol Meyers Squibb, Bryllan , Boehringer Ingelheim, Fresenius Kabi, Genentech, Glaxo Smith Kline, Johnson & Johnson, Merck, Pfizer, and Vetter.
  • Access to global industry leaders and regulators – This event provides unique access not only to the representatives from these leading sterile manufacturers, but also to FDA regulators and keynote speakers who set policy and direction for the industry.
  • A new third track in addition to the two historical Barrier and Aseptic Tracks – The new Containment Track will offer insights into the challenges of achieving containment and sterility at the same time, processing highly potent/toxic products such as antibody-drug-conjugates (ADCs ).

Register Today