2023 ISPE Aseptic Conference

Conference Overview

Please Note:

  • All full-access registration (virtual & in-person) includes access to speaker presentations, on-demand content, and other conference material.
  • NOTE: Material is only available from those speakers/companies that permitted distribution.
  • Registrants will receive email notification when the on-demand content is available.
  • On-demand content is accessible for 90 days.

Access Conference Platform

The need to take advantage of new technologies and explore new ways for process control and efficiency permeates all areas of pharmaceutical manufacturing. Recent emerging technologies in aseptic processing such as advanced isolators, robotics, and increased automation have changed the industry and reduced contamination risks for sterile products. Simultaneously, modern therapies - new, targeted approaches to treatment resulting in small-batch aseptic products - are proving more difficult to sterilize and handle and requiring faster speeds to market. Furthermore, the updated Annex 1 will impact the manufacture of sterile products, setting new requirements for Quality Risk Management, Contamination Control Strategy, and Data Management and Compliance for Computerized Systems. The requirement to re-think the existing standards is becoming more urgent.

Thus, as we slowly navigate to the post-COVID world and return to the new normal, ISPE’s Aseptic Conference wants to realign our focus. We welcome you to participate at the 2023 ISPE Aseptic Conference to learn and share progress, success stories, best practices and lessons learned. See you in North Bethesda, Maryland!

Featured Speakers

Attendee Prospectives

Featured Topics

  • Annex 1 Solutions and Implementation
  • Robotics and Digitalization
  • Manufacturing Case Studies
  • Process Control and Quality Risk Management
  • ATMPs/Cell & Gene Therapies
  • Contamination Control in Aseptic Processing
  • Decontamination and Single-use Systems
  • Improvements and New Technologies in Aseptic Manufacturing
  • Microbiology, Cleaning, and Training
  • 3 Discussion Groups: Aseptic Processing, Contamination Control, and Barrier Technologies

What to Expect

The #1 event for aseptic and sterile manufacturing professionals that has been setting the pace for over 30 years.

  • Gain first-hand insights on the newly revised Annex 1, including discussions with ISPE members and stakeholders who provided comments on the draft
  • Identify the impact and potential utilization of new technologies, including robotics and digitalization trends
  • Examine harmonized approaches to innovative design solutions and project delivery strategies
  • Engage directly with regulators about regulatory and quality challenges, learnings, and opportunities
  • Explore emerging technologies and practices that are helping drive a revolution in aseptic manufacturing


  • 7.5+ hours of dedicated networking time.
  • 11.5+ hours of dedicated education sessions & learning opportunities.
  • 5+ hours of additional sessions available on-demand after the conference. 16.5+ hours total of education from all conference sessions.
  • Expansive Expo Hall.
  • Expo Hall giveaways & engagements.
  • Growth opportunities for Students, Women in Pharma and Emerging leaders.
  • 90-minute concurrent sessions with audience interaction.
  • Conveniently located in North Bethesda, Maryland.
  • Unique perspectives from both industry and regulatory speakers to obtain a wholistic understanding of the trends and issues impacting the Sterile Manufacturing practices.

Conference Highlights

Program Committee

Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Alice Redmond, PhD
Chief Strategy Officer
Foundation Board Liaison
Timothy J.N. Watson, PhD
Executive Director & Team Leader, CMC Advisory Office
Foundation Board Liaison
Francesco Cicirello
Senior Director, Quality Assurance
Evelo Biosciences
Richard Denk
Senior Consultant Aseptic Processing & Containment
Alexander Haig
Vice President, Operations
INCOG BioPharma Services, Inc.
Michael G. Higgins
Sr. Director External Engagement and Supplier Quality
Moderna Therapeutics
Chervee Ho
Senior Director of Life Science Sales, Asia Pacific
Ryan Paul Mazur
Process Engineer
Christa B. Myers
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader
Nidhi C. Shah
Director Aseptic Processing SME
Sanofi Pasteur – Swiftwater
Klaus Ullherr
Senior Product Manager
Syntegon Technology GmbH
Keith W. Weseli, CPIP
Commissioning and Qualification Project Director
Stevanato Group