Manufacturing and Development of Antibody Drug Conjugates
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    Manufacturing of Antibody Drug Conjugates

     

    2 – 4 April 2025, live online training

    Summary

    The objective of this course is to provide you with tools for navigating the regulatory landscape, developing a robust CMC strategy and understanding the manufacturing process. Combined with a sound understanding of these complex melecules, including the mechanisms of action and pharmacology, you will be able to submit good filings and avoid market delays.

     

    Learning Objectives

    • Understand the regulatory frameworks governing ADCs
    • Develop effective CMC strategies to ensure product quality and compliance
    • Implement robust quality control and assurance measures throughout the development lifecycle
    • Gain insights into manufacturing processes specific to ADCs
    • Understand analytical methods for characterisation and stability assessment
    • Navigate Change & lifecycle management effectively
    • Mitigate risks and maintain compliance with regulatory requirements
    • Understand emerging trends in ADCs
    • Understand the importance of formulation risk management
    • Learn the latest trend in Quality by Design (QbD) and how to implement best practices for ADCs
    • Learn how to conduct a comparability study for ADCs
    • Avoid delays in clinical development and market approval

    Key Topics

    • Regulatory Frameworks and Guidelines
    • CMC Strategies for ADCs
    • Quality Control and Assurance
    • Manufacturing Processes
    • Analytical Methods and Characterisation
    • Stability Studies and Comparability Assessments
    • Post-Approval Changes and Lifecycle Management
    • Risk Management and Compliance

    Who should attend?

    This course is suitable for all those involved in:

    • Quality
    • CMC
    • Regulatory Affairs
    • Manufacturing/ MSAT
    • Process Development
    • R&D Scientists

    Past delegate profile

    • CMC Project Manager, Mithra Pharmaceuticals
    • Regulatory Affairs Project Manager, Lonza
    • Senior Manager, European Central Regulatory Affairs, Mylan/Viatris
    • Head of Manufacturing, Biotalys
    • Head R&D Development Unit, GSK Vaccines
    • Senior Manager, Regulatory CMC, Takeda Manufacturing
    • Associate Manager Regulatory Information Management, Regeneron
    • CMC Lead, Uniqure
    • Regulatory Affairs Specialist, Novavax
    • Associate LI, Regulatory Affairs CMC, Gilead Sciences
    • QC Manager, Bayer
    • Regulatory Affairs Specialist, CSL Behring

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 7 days
    • Digital and LinkedIn certificates

    Trainers

    Len has over 30 years of experience in both industry and academia. He is a member of a regulatory advisory group for ATMPs. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. His regulatory and licensing experience covers the MHRA, EMA and FDA.
    ADC development and manufacturing

    Manufactuing of Antibody Drug Conjugates

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    Online Participation
    1 850  Price incl. VAT: 1 850 

    Price per delegate including:

    Online participation

    Online workbook & materials

    Recorded sessions for 7 days

    Certificate

    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori

    l.makori@symmetric.events
    +421 222 200 543

    Training Details
    • Start Date
      2. April 2025
      02:00 PM Vienna time
      01:00 PM London time
      08:00 AM New York time
      05:00 AM Los Angeles time
    • End Date
      4. April 2025