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2023 PDA_Training-1988x680

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

Sep 14 - Sep 15, 2023
Seville, Spain

  • Education
  • Europe
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Overview

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.

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Agenda

  • Day 1
  • Day 2

  • Thursday, 14 September 2023

    9:00
    Welcome and Introduction

    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

  • 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 

    17:00
    End of Training Course

Trainers

John Geigert
John Geigert
Biopharmaceutical Quality Solutions
Bio
John Geigert
Biopharmaceutical Quality Solutions

John Geigert, Ph.D., RAC is President of BioPharmaceutical Quality Solutions, in San Diego, California, which for over 15 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical industry (recombinant proteins, monoclonal antibodies), and now for the advanced therapy products (gene and cellular therapy). Dr. Geigert has over 35 years of experience within the biopharmaceutical industry developing and implementing CMC regulatory compliant strategies for biopharmaceuticals. He has 10 years Executive Management experience as Vice President, Quality & Executive Officer at IDEC Pharmaceuticals, and Vice President, Quality at Immunex. He has served on the PDA Board of Directors and chaired the PDA Biopharmaceutical Advisory Board. Dr. Geigert is also the author of the book, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals 3rd Edition.

Additional Information

  • Learning Objectives

    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
  • Who Should Attend

    This training course is intended for professionals who are involved in the manufacturing, quality and GMP compliance of ATMPs during clinical stages of development.

    Departments
    • Regulatory Affairs
    • Research and Development
    • Quality Compliance
    • Manufacturing
    • Quality Assurance Operations
    • Technical Operations
    • Training
    Roles
    • Auditor/Inspector
    • Operator/Technician
    • Supervisor
    • Senior Manager
    • Engineer
    • Director

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Travel

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.

Melia Lebreros

C. Luis de Morales, 2
Seville, Spain
Phone: +34 954 57 94 00

  • Accommodations

    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.

  • Amenities

    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.

Other Options

Only 30 minutes by train from the airport to the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 1.895

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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