PDA EU00183 CMC Regulatory Compliance Strategy for Recombinant Proteins and Monoclonal Antibodies

Seville, Spain
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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

Standard Registration

Member Price

€ 1.895

GovernmentMember Only

€ 1.895

Health AuthorityMember Only

€ 1.895

Early Career ProfessionalMember Only

€ 1.895

StudentMember Only

€ 1.895

AcademicMember Only

€ 1.895


€ 1.895

See Qualifying Criteria for Member Types.


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

Welcome and Introduction, collecting Participant's Expectations 

CMC Regulatory Compliance is Challenging for the Recombinant Proteins and Monoclonal Antibodies

Discussion of the increasing diversity of recombinant proteins and monoclonal antibodies and the CMC regulatory challenges that they present

10:30 Coffee Break


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


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

15:00 Coffee Break


Introduction of the ICH strategic risk-based approach of Quality by Design and Quality Risk Management to biopharmaceutical manufacturing and product testing

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


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


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


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


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 


Final Q&A

End of Training Course

Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA recommends the reservation at the following hotel

Melia Lebreros
C. Luis de Morales, 2
41018 Seville

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.

How to Get Here
By Air The hotel is only 8 kilometers away from Seville International Airport.
By Car On site parking is available. Please contact the hotel for more information.