PDA EU00191 CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies and Biosimilars
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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 substrate), Process Development (design of the cell culture and purification manufacturing process), Analytical Development (design of the release/stability test methods), Manufacturing (cell banking, 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). The coordination and timely completion of all the activities by all these CMC groups is necessary for entering clinical development and for continuing to eventually obtain market approval.
While many CMC teams are familiar with the CMC regulatory compliance strategy for chemical drug products, they may not appreciate the significant differences and extra challenges in the CMC regulatory compliance strategy for the large size and complex protein-based biopharmaceuticals, which today now include recombinant proteins, monoclonal antibodies (mAbs, bispecific antibodies, Fc fusion proteins, Fab fragments, and antibody-drug conjugates (ADCs)) and biosimilars. Examples of CMC strategies that worked and those that did not work will be discussed.
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 these protein-based biopharmaceuticals 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 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 biopharmaceuticals 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
Thursday, 26 September 2024
9:00
Welcome and Introduction, collecting Participant's Expectations
9:10
Challenges from the Protein-Based Biopharmaceutical Landscape
- Discussion of the CMC challenges due to the increasing diversity of these market-approved biopharmaceuticals (rProteins, mAbs, BsAbs, Fc fusion proteins, Fab fragments, ADCs, biosimilars)
- The critical role that Genetic/Process/Analytical Development groups, Manufacturing, QA/QC and Regulatory Affairs have in assuring that CMC regulatory compliance protects patients
10:30
Coffee Break
11:00
CMC Regulatory Compliance Differences
- Overview of the FDA/EMA regulatory systems in place for these products (IND → BLA; IMPD → MAA)
- Why these products are not regulated like chemical drugs
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 (MCB/WCB)
17:00
End of Training Course Day 1
Day 2
Friday, 27 September 2024
9:00
Applied Risk-Managed CMC Regulatory Compliance Strategy Across the Manufacturing Process
- Upstream cell culture production and downstream purification processes
- ‘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 authority guidance in planning for product comparability studies
- Three risk-based considerations to reduce residual uncertainty of product comparability
- Biosimilarity and interchangeability for biosimilars
- Industry experience in implementing product comparability after manufacturing process changes
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 biopharmaceuticals
- Intensity of the regulatory authority review process to obtain market approval
17:00
End of Training Course
Featured Trainers
-
John Geigert, PhD, RAC
Biopharmaceutical Quality Solutions
Read BioJohn 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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