2024 ISPE Aseptic Conference

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Conference Overview 

Recent advancements in aseptic processing, such as advanced isolators, robotics, and increased automation, have transformed the industry whilst simultaneously reducing the risks of contamination for sterile products. However, modern therapies - innovative, targeted treatments that result in small-batch aseptic products - require faster speeds to market and present unique sterilization and handling challenges. This dichotomy presents unique challenges for the industry to address.

Moreover, the updated Annex 1 is impacting the manufacturing of sterile products, necessitating updated requirements such as Quality Risk Management, Contamination Control Strategy, and Data Management and Compliance for Computerized Systems.

Programme highlights for the 2024 ISPE Aseptic Conference include:

  • Regulatory Key Notes from the German and Austrian Authorities: Christina Meissner and Daniel Müller
  • Industry Key Notes from the Austrian Pharma Association and the site head of Takeda in Vienna: Alexander Herzog and Maria Löfflund
  • Technical discussions around the implementation of Annex 1:
    • Contamination control strategy
    • Aseptic process simulations
    • Air flow visualisation
    • Decontamination using hydrogen peroxide
    • Microbiological monitoring
    • And more!
  • Automation, use of robots
  • A track on gloveless isolators with a moderated discussion with a large number of suppliers: Syntegon, Cytiva, Pharma Integration/PM Group, AST, Groninger, IMA
  • An international regulatory panel with: Christina Meissner, AGES, Daniel Müller, RP Tübingen, Vimal Sachdeva, WHO, Rick Friedman, FDA, Christian Schärer, Swissmedic and Matt Davis, TGA.

The 2024 ISPE Aseptic Conference will provide an ideal opportunity for participants to share progress, success stories, best practices, and lessons learned. Get ahead of the game with a focus on novel therapies, emerging technologies, and aseptic processing. We look forward to seeing you in Vienna, Austria!

Regulatory Presence at the 2024 ISPE Aseptic Conference:


Featured Speakers

Christina Meissner
GMP Inspector
AGES - Austrian Agency for Health and Food Safety
Daniel Mueller
Regierungspraesidium Tuebingen
Maria Löflund
Site Head Vienna
Takeda Manufacturing Austria AG
Alexander Herzog
Secretary General
PHARMIG – Association of the Pharmaceutical Industry in Austria

Conference Topics 

Given the impact of the evolving pandemic, an ageing population, the increase in diseases with unmet needs, and an unprecedented rise in chronic diseases, the need for a constant focus on collaborative innovation and agility will shape Pharma’s priorities in the foreseeable future. ISPE will be the leader in setting the pace for knowledge sharing that speaks to the current and future needs of the industry.   


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International Programme Committee

Christa B. Myers
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader
Jörg Zimmermann
Vice President Vetter Development Service External Affairs
Vetter Pharma Fertigung GmbH & Co KG
Past Chair
Norman A. Goldschmidt
Genesis AEC
Board Liaison/Foundation Board Liaison
Nidhi C. Shah
Senior Director, Value Stream CAR - T Manufacturing Operations
Bristol Myers Squibb
Women in Pharma® Liaison
Massimiliano Cesarini, MSEng
Managing Director - Life Sciences
Omnia Technologies
Francesco Cicirello
Senior Director, Quality Compliance BioNTainer
BioNTech US Inc.
Richard Denk
Senior Consultant Aseptic Processing & Containment
Matthew P. Gorton
Director of Business Development
GBA Life Sciences
Alexander Haig
Vice President, Operations
INCOG BioPharma Services, Inc.
Michael G. Higgins
Global Head Compliance and Inspection Management
Ryan Paul Mazur
Process Engineer II
Genesis AEC
Klaus Ullherr
Senior Product Manager
Syntegon Technology GmbH
Keith W. Weseli, CPIP
Site Quality Project Director
Stevanato Group

Conference Sponsors