Microbiological Control of Cell- and Gene-Based Products/ATMPs

03 May 2022

Objectives

The number of cell-, tissue- or gene-based advanced therapy medicinal products (ATMPs) in research, development and production is steadily increasing. Due to the very different characteristics of the biological materials, the often small batches, the limited shelf life or the bio-safety requirements of the manufacturing environment, conventional control methods can often only be used to a limited extent. Alternative approaches for microbiological control, independent whether we are talking about sterility testing, endotoxin detection or others, are often necessary for such products.

The following conference will provide insight into how pharmacopoeias deal with this, the experiences and expectations of regulatory authorities and how microbiological control and testing strategies and methods are implemented in industry and laboratories. During the Q&A-session you will also have the opportunity to ask the speakers your individual questions.

Target Audience

This track provides information for all industry, authority or laboratory personnel involved in the microbiological control of cell and tissue products or gene therapeutics.

Moderators

Dr Sven M. Deutschmann
Roche, Chair of the ECA Pharmaceutical Microbiology Working Group

Axel Schroeder
Concept Heidelberg

Programme

Welcome and and Organisationals
Axel H. Schroeder

Introduction - Overview ATMP’s -MTS / MTO-Products
Dr Sven M. Deutschmann, Roche

  • ATMP Product Classes impacting the microbial control concept
  • Shelf-life of the different products classes
  • Volumes of products available for testing purposes

E2E perspective to the identification of pre-cQAs of GT products
Dr Roland Pach, Roche

  • QbD approach and cQA identification in Biologis
  • Challenges of GT based therapeutics
  • A potential path for the identification of pre-cQAs of GT products
  • Snapshot of current microbial control strategy & its needs for innovative solution

European Pharamcopoeia Perspective
Dr Solène Le Maux, EDQM, Council of Europe

  • Presentation of the microbiological testing approaches for cell and tissue-based preparations available in the Ph. Eur.
  • Focus on the new general chapter Microbiological examination of human tissues (2.6.39.)
  • Update on the activities of the Ph. Eur. in the ATMP field

Introduction to the new USP chapter on microbial control strategies for cell and gene therapy products
Dr David Rösti, Novartis

  • General outline of the chapter will be presented
  • Risk considerations and categories
  • Considerations for manufacturing facilities, operations and materials

Bacterial Safety of ATMP
Dr Oleg Krut, Paul-Ehrlich-Institut

An Alternative Sterility Testing Approach
Joseph Pierquin, RedBerry

  • Autogene cevumeran introduction
  • Turnaround Time (TAT) requirements
  • The autogene cevumeran microbial control strategy
  • Conclusion

Viral safety concepts for ATMPs
Dr Johannes Blümel, Paul-Ehrlich-Institut

  • Control of raw materials
  • Testing of cell cultures
  • Viral vectors

Contamination Control of Therapeutic Virus Production
Dr Michael Ruffing, Boehringer Ingelheim

  • Safety strategy elements
    Control of adventitious agents throughout the manufacturing process
    Testing strategy for raw and starting materials, intermediates and DS/DP

Microbial control strategy for autogene cevumeran a cell-free, individualized, mRNA based ATMP
Dr Friedrich von Wintzingerode, Genentech

  • Autogene cevumeran introduction
  • Turnaround Time (TAT) requirements
  • The autogene cevumeran microbial control strategy
  • Conclusion

Aseptic Process Validation in the Cocoon® Platform
Laura Sands, Lonza

  • Strict adherence to aseptic processing guidelines is essential for ATMPs, such as cellular products or large viral vectors, that are unable to be terminally sterilized. Conducting Aseptic Process Validation for traditional ATMP manufacturing processes is complex due to the high number of manual manipulations and overall process complexity.
  • Improvements in process robustness, efficiency, and contamination control can be realized by utilizing closed, automated, cell therapy manufacturing systems such as the Cocoon® Platform.
  • The use of closed, automated manufacturing technologies is gaining traction and recognition by industry and regulatory agencies.
    Lonza will share data from in-house Aseptic Process Validation studies that demonstrate the ability of such systems to effectively produce sterile product and streamline Aseptic Process Validation.
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