PDA EU00190 CMC Regulatory Compliance Strategy for ATMPs – CGTPs
Advanced Therapy Medicinal Products - Cellular/Gene Therapy Products
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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.
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.
Learning Objectives
Upon completion of this course, attendees will be able to:
- Understand the importance and underlying principles of an effective CMC regulatory strategy for ATMPS – CGTPs to move their products through clinical development into the marketplace
- Learn how to avoid major CMC delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy
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€ 2.090Non-Member
€ 2.090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
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Day 1
Monday, 23 September 2024
9:00
Welcome and Introduction, collecting Participant’s Expectations
9:10
CMC Regulatory Compliance is Challenging for ATMPs-CGTPs
- Discussion of the increasing diversity of ATMPs-CGTPs and the CMC regulatory challenges they present
- The critical role that the Genetic/Process/Analytical Development groups, Manufacturing, QA/QC and Regulatory Affairs have in assuring that the CMC regulatory compliance protects patients
10:30
Coffee Break
11:00
Similarities/Differences in CMC Regulatory Compliance
- FDA/EMA regulatory systems in place for ATMPs-CGTPs
- Understanding why these products are not regulated like chemical drugs (or in some cases, even like protein-based biopharmaceuticals)
12:30
Lunch Break
13:30
Risk-Managed CMC Regulatory Compliance Strategy
- Why a risk-managed approach to CMC regulatory compliance is absolutely necessary for these products
- Application of Quality by Design (QbD) – QTPP, CQA, CPP – and Quality Risk Management (QRM)
15:00
Coffee Break
15:30
Applied Risk-Managed CMC Regulatory Compliance Strategy Across the Manufacturing Process
- Raw materials and components – risk reduction procedures
- Starting materials (DNA plasmids, viral vectors (LV, mRNA non-viral vector, patient/donor cells)
17:00
End of Training Course Day 1
Day 2
Tuesday, 24 September 2024
9:00
Applied Risk-Managed CMC Regulatory Compliance Strategy Across the Manufacturing Process
- Upstream production (transfection, transduction) and downstream purification processes (viral and non-viral vectors)
- ‘Minimum CMC regulatory compliance continuum’ applied to manufacturing process control
10:30
Coffee Break
11:00
Applied Risk-Managed CMC Regulatory Compliance Strategy Across the Manufacturing Process
- Formulation and drug product manufacturing processes
- Product testing and specification assignments
- Administering the final drug product – vial to vein concerns
12:30
Lunch Break
13:30
Challenges in Demonstrating Product Comparability After Manufacturing Changes
- Regulatory guidance in planning for product comparability studies – adapting ICH Q5E
- Three risk-based considerations to reduce residual uncertainty of product comparability
- Industry experience in controlling process changes for ATMPs-CGTPs
15:00
Coffee Break
15:30
Critical Manufacturing/Quality-Focused Meetings with Regulatory Authorities
- CMC regulatory compliance deficiencies can seriously delay clinical development advancement
- Meeting opportunities with regulatory authorities for ATMPs-CGTPs
17:00
End of Training Course
Featured Trainers
-
John Geigert, PhD, RAC
Biopharmaceutical Quality Solutions
Read Bio
John Geigert, PhD, RAC
Biopharmaceutical Quality Solutions
John Geigert is President of BioPharmaceutical Quality Solutions, in San Diego, California.
He has over 40 years of experience within the biopharmaceutical industry developing Chemistry, Manufacturing & Controls (CMC) regulatory-compliant strategies for biologics, including gene therapy vectors and cell-based medicines. Dr. Geigert has 10 years of Executive Management experience as Vice President, Quality & Executive Officer at IDEC Pharmaceuticals, and Vice President, Quality at Immunex. He has served for 20 years as an international independent CMC regulatory compliance consultant. He is a past chair of the PDA Biopharmaceutical Advisory Board. Dr. Geigert is also the author of the book, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals 4th Edition (June 2023).
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