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2023 PDA_Training-1988x680

PDA EU00190 CMC Regulatory Compliance Strategy for ATMPs – CGTPs

Sep 23 - Sep 24, 2024
Gothenburg, Sweden

Advanced Therapy Medicinal Products - Cellular/Gene Therapy Products

  • Education
  • Europe

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Chemistry, Manufacturing & Control (CMC) regulatory compliance strategy encompasses all of those activities that are required/expected to be carried out by a regulatory authority to protect the patient from the manufactured drug product. Such activities involve Genetic Development (gene development, cell clonality), Process Development (design of the manufacturing process), Analytical Development (design of the release/stability test methods), Manufacturing (carrying out the upstream and downstream, and drug product processes), Quality Control (testing to meet specifications), Quality Assurance (cGMP compliance) and Regulatory Affairs (communication with the authorities). Compared to other biologic drug products, the coordination and timely completion of all the activities by all these CMC groups has never been more needed than for ATMPs/CGTPs.

While many CMC teams are familiar with the CMC regulatory compliance strategy for other drug products (e.g., chemical drugs, monoclonal antibodies), they may not appreciate the significant differences and extra challenges in the CMC regulatory compliance strategy for ATMPs/CGTPs. These extra CMC challenges are due to the increased size and complexity of these biologics (infectious AAV viral vectors, mRNA non-viral vectors, living genetically modified patient cells), as well as the limitations of the manufacturing processes (e.g., limited number of batches, increased biological variability).

This course will provide insights and practical guidance for the CMC teams to develop a cost-effective, risk-based CMC regulatory compliant strategy for the manufacture and control of ATMPs/CGTPs from first-in-human (FIH) clinical studies through market approval. The course emphasis will include CMC regulatory guidance (FDA, EMA and ICH), as well as real-world case examples illustrating CMC regulatory compliance delays in advancing clinical development.


  • Day 1
  • Day 2
  • Thursday, 14 September 2023

    Welcome and Introduction

    CMC Regulatory Compliance is Challenging for Biopharmaceuticals

    Discussion of the increasing diversity of biopharmaceuticals and the CMC regulatory challenges that they present

    Coffee Break


    Understanding the similarities and differences in CMC regulatory compliance between FDA and EMA for biopharmaceuticals

    Biopharmaceuticals are not chemical drugs – CMC regulatory compliance consequences of the major differences

    Lunch Break

    Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy


    Three (3) interactive components that protect patients – CMC, cGMPs and Quality Systems

    What the ‘minimum CMC regulatory compliance continuum’ means for biopharmaceuticals during clinical development

    Coffee Break


    Effective CMC risk-management – the five (5) key design elements

    Applying the principles of QbD and QRM to biopharmaceutical manufacturing

    End of Training Course Day 1

  • Friday, 15 September 2023

    Applied Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy – Cell Bank through Drug Substance


    CMC strategy applied across the manufacturing process from cell banks to protein production to purification to drug substance

    Necessity of confirming cell bank clonality and genetic stability

    Coffee Break


    Importance and limitations of small-scale studies for biopharmaceuticals

    Adequate and appropriate control of the biopharmaceutical manufacturing process from early clinical development into the marketplace

    Extra CMC challenges of antibody-drug conjugates (ADCs)

    Lunch Break

    Applied Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy – Bulk Drug Substance through Administered Drug Product


    CMC strategy applied across the manufacturing process from bulk drug substance to formulation to drug product filling to final drug product to administered drug product

    Formulation and container-closure challenges for biopharmaceuticals – Impact of components on the biopharmaceutical (e.g., protein aggregation) and impact of the biopharmaceutical solution on the components (e.g., glass delamination)

    Coffee Break


    Demonstrating Biologic Comparability After Manufacturing Process Changes

    Three (3) key design elements of an effective risk-managed comparability exercise

    Comparability contracts with regulatory authorities

    End of Training Course

Additional Information

  • Learning Objectives

    Learning Objectives

    • Understand how CMC Regulatory, cGMPS and Quality System interactively provide patient protection for the manufactured cell and gene therapy products
    • Explain why a risk-based flexible approach is absolutely required for these advanced therapy medicines
    • Discuss where it is appropriate and acceptable to apply a minimum CMC regulatory compliance continuum across the manufacturing of these products during clinical development
    • Learn how to effectively manage product comparability for ATMP manufacturing process changes
  • Who Should Attend

    This two-day CMC regulatory compliance strategy course for ATMPs/CGTPs is designed for senior management, directors, managers, supervisors, project managers, and personnel in Process/Analytical Development, Manufacturing, Quality, and Regulatory Affairs departments.

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Gothenburg, Sweden

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Registration Fees

Regular Price
Registration Type Price
All Participants € 2.090

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