PDA EU00183 CMC Regulatory Compliance Strategy for Recombinant Proteins and Monoclonal Antibodies
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Biopharmaceuticals (recombinant proteins, monoclonal antibodies, Fc-fusion proteins, fragment Fabs, bispecific antibodies, antibody-drug conjugates, and biosimilars) are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging manufacturing processes and complex products.
Frequently the development of the CMC regulatory strategy is an afterthought. 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 the protein-based biopharmaceuticals from first-in-human (FIH) clinical studies through market approval. The course emphasis will include FDA, EMA and ICH guidance. Real-world case examples of CMC regulatory compliance problems and delays affecting recombinant proteins, monoclonal antibodies, engineered antibodies and biosimilars will be discussed.
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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Standard Pricing
Standard Member Price
€ 1.895GovernmentMember Only
€ 1.895
Health AuthorityMember Only
€ 1.895
Early Career ProfessionalMember Only
€ 1.895
StudentMember Only
€ 1.895
AcademicMember Only
€ 1.895
Non-Member
€ 1.895
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Thursday, 14 September 2023
9:00
Welcome and Introduction, collecting Participant's Expectations
CMC Regulatory Compliance is Challenging for the Recombinant Proteins and Monoclonal Antibodies
9:10
Discussion of the increasing diversity of recombinant proteins and monoclonal antibodies and the CMC regulatory challenges that they present
10:30 Coffee Break
11:00
Protein-based biopharmaceuticals are not chemical drugs – CMC regulatory compliance consequences due to the major differences
12:30 Lunch Break
Risk-Based Approach to Managing the CMC Regulatory Compliance Strategy for Recombinant Proteins and mAbs
13:30
Defining the ‘minimum CMC regulatory compliance continuum’ for biopharmaceuticals during clinical development
15:00 Coffee Break
15:30
Introduction of the ICH strategic risk-based approach of Quality by Design and Quality Risk Management to biopharmaceutical manufacturing and product testing
17:00
End of Training Course Day 1
Day 2
Friday, 15 September 2023
Applying the Risk-Managed CMC Regulatory Compliance Strategy – Master Cell Bank through Drug Substance through Drug Product
9:00
Developmental genetics – necessity of clonality and genetic stability
Difference in CMC regulatory requirements for MCBs to enter First-in-Human clinical studies versus to obtain market approval
10:30 Coffee Break
11:00
Importance/limitations of reduced-scale studies for biopharmaceutical protein production and purification
Extra CMC regulatory challenges of antibody-drug conjugates (ADCs)
12:30 Lunch Break
Applied Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy – Bulk Drug Substance through Administered Drug Product
13:30
Drug product challenges for biopharmaceuticals – Impact of contact surfaces on the biopharmaceutical (e.g., protein aggregation) and impact of the biopharmaceutical solution on contact surfaces (e.g., glass delamination)
Applied CMC strategy for the administered protein-based drug product
15:00 Coffee Break
15:30
Challenges of Demonstrating Protein-Based Biopharmaceutical Comparability After Manufacturing Process Changes
Three (3) key design elements for an effective risk-managed comparability exercise
Obtaining comparability contracts (PACMPs) with regulatory authorities
16:30
Final Q&A
17:00
End of Training Course
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PDA recommends the reservation at the following hotel
Melia Lebreros
C. Luis de Morales, 2
41018 Seville
Spain
Tel: +34 954 57 94 00
PDA Europe has reserved a limited number of rooms by 01 August 2023.
Book your room at the PDA Group Rate via the above-mentioned reservation button.
The hotel is located in the heart of Seville, next to the Royal Alcazar and the Plaza de Espana including a 270 qm swimming pool and a fully equipped fitness area.