2023 ISPE Aseptic Conference

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 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!

Submit Proposal


Call for Proposals Timeline

  • Submission Deadline
  • Committee Review Begins
  • Submitters Notified of Committee Decision

Requested Submission Topics 

Given the impact of the evolving pandemic, an aging 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 to set the pace for knowledge sharing that speaks to the current and future needs of the industry.  

The 2023 ISPE Aseptic Conference reviewers are requesting proposals aligning with the following content areas:

  • Manufacturing Trends

    Applying harmonized approaches to innovative design solutions and project delivery strategies to ensure that quality therapeutic products are brought to market in an efficient manner to improve patient health. This includes manufacturing process improvement, the business strategies, and technology associated with the future state of manufacturing.

  • Regulatory, Compliance, & Quality

    Regulatory and quality challenges, learnings, and opportunities which might include the current speed to market expectations, pandemic management, drug shortages, and the regulatory focus on data integrity and sterile manufacturing.

  • Supply Chain Optimization

    The impact and potential utilization of new technologies, processes, and disruptions on operations and logistics of the production of all types of therapies.

  • Therapy Innovations

    Emerging and evolving technologies and practices that are helping drive a revolution in medicinal therapies, analytical techniques, manufacturing paradigms, medical devices including novel methods to deliver the next generation of drugs to patients.

Examples of possible submissions/case studies/use cases could be any of the following:

  • New Robotics Applications in Aseptic Processing
  • Pharma 4.0/Digitalization/Data Integrity/AI in Sterile Manufacturing
  • Advanced Therapy Medicinal Products (ATMPs) and cell/gene therapy in aseptic manufacturing
  • Automation and Reducing Operator Interaction, Light Out Operations
  • Fill-Finish
  • Enzyme Indicators/ Biological Indicators
  • Contamination Control
  • BioSafety Manufacturing Requirements
  • Data Analysis
  • Regulatory Compliance
  • Regulatory Constraints
  • Single Use Technologies
  • Recent RABS and Isolator Installations: Case Studies
  • Parametric release
  • Batch processing
  • Annex 1: Implementation Strategies
  • Cleaning and Cross Contamination Control Strategies
  • Continuous Manufacturing for Sterile Products
  • Emerging Aseptic Technologies: Rapid Microbiological and Online Testing
  • Flexible and Multi-Product Facilities: Case Studies
  • Flexible small-scale manufacturing for development and clinical trials
  • High Potent Compounds, Containment, and Sterility
  • Supply Chain Issues, Operation Readiness, and Regulatory Challenges
  • Vaccine Production: Case Studies
  • Scale-out vs. scale-up for machinery
  • Standardization vs. customization for machinery
  • Upgrades and Renovations of Aging Facilities: Case Studies
  • Cleaning and Sanitization - Residue reduction
  • Sustainability
  • PUPSIT
  • Aseptic Operation Training- Virtual Reality
  • Glove Management and Testing

Proposal Submission Type

Abstract submissions are to be submitted as individual, 20-minute presentations

These presentations are to be made part of a larger session by the Program Committee. Presentation should focus on new and innovative trends, a specific real-world strategy or campaign, a “how-to" presentation intended to help attendees gain a better understanding of the initiative and best practices that they can apply to their day-to-day objectives or overall missions.


Proposal Guidelines

  • All presentations must be free of commercial intent. Incomplete proposals will not be considered.
  • By submitting a proposal, you acknowledge that, if your proposal is accepted, the speaker will attend/present in-person at the event and the speaker’s attendance at the event will be supported by their organization.
  • Accepted Aseptic Conference speakers are responsible for their own travel and accommodations.
  • Speakers giving at least a 20-minute presentation (not including Q&A) receive complimentary conference registration.
  • Co-Speakers, Panelists, and Poster Presenters receive a 20% discount on conference registration.
  • NOTE: Exhibitors who are accepted to present are required to register as a paid conference attendee (with 20% discount off prevailing registration rate). Complimentary booth staffing registrations cannot be utilized for the presentations as these are part of the education sessions and not the exhibition.
  • Consulting firms or vendor/suppliers are expected to include a speaker from an owner company to present.
  • Regulators interested in submitting a proposal: Please contact Saana Tykka to submit your abstract.

Program Committee

Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Chair
Francesco Cicirello
Director, Quality Assurance
Evelo Biosciences
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Alexander Haig
Vice President, Engineering
INCOG BioPharma Services, Inc.
Michael G. Higgins
Sr. Director External Engagement and Supplier Quality
Moderna Therapeutics
Ryan Paul Mazur
Process Engineer
Genesis
Christa B. Myers
Aseptic and Sterile Products Market Director
CRB
Co-Chair
Nidhi C. Shah
Director Aseptic Processing SME
Sanofi Pasteur – Swiftwater
Klaus Ullherr
Senior Product Manager
Syntegon Technology GmbH
Keith W. Weseli, CPIP
Director of Operations, Midwest Region
CAI