11th Workshop on Monoclonal Antibodies

Seville, Spain
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Program Highlights

This year, the conference will be part of the PDA Europe Exchange Series and held in parallel to the Pharmaceutical Freeze Drying Technology Conference. 

Speakers from International Regulatory Agencies will be presenting on site and available for Q&A and discussions!

  1. US:FDA
  2. Europe: EDQM
  3. Germany: Paul-Ehrlich-Institut
  4. The Netherlands: Medicines Evaluation Board
  5. Spain: AEMPS

Make sure to take advantage of this 2-for-1 Exchange Series Event and review both conference agendas in the download brochure!


Dear Colleagues,

On behalf of the program planning committee and PDA, we are pleased to invite you to attend the 2018 PDA Europe 11th Workshop on Monoclonal Antibodies, to be held 27-28 November 2018 in Seville, Spain.

Since the first licensed product in 1986, monoclonal antibodies have dominated the field of biopharmaceuticals with more than 70 approved products and hundreds more currently undergoing clinical evaluation for a variety of diseases.  Market evaluations for monoclonal antibodies predict no decline in interest for many years to come. 

The knowledge gained over decades of discovery research, development and manufacturing has enabled tremendous advancements in the commercialization of therapeutic monoclonal antibodies. In addition to fully human and humanized monoclonal antibodies, new related modalities have been introduced such as antibody fragments, Fc-fusions, bi-specifics and antibody drug conjugates all aimed at improving pharmacological properties.   Technology improvements in expression systems, cell culture and downstream purification have increased efficiency and productivity. The ability to apply common unit operations across multiple monoclonal antibodies has allowed manufacturers to develop platform processes and in turn accumulate substantial knowledge applicable to future molecules in their portfolios.  Many companies are now adopting continuous manufacturing approaches to further streamline production and reduce operating expenses.

The regulatory environment has kept pace with these achievements by supporting innovation and ensuring patient access to novel monoclonal antibody products. Various guidance documents have been published outlining regulatory expectations. In addition, regulatory frameworks have been established to enable the commercialization of biosimilar monoclonal antibody products.

With so much accumulated knowledge related to monoclonal antibodies, the focus is now on how best to make use of all the information.  The term Prior Knowledge is applied to describe this wealth of information and the subject is a hot topic amongst industry and regulators.  For this reason, the program planning committee selected Prior Knowledge as the theme for this year’s workshop.  Objectives for the workshop are to answer key questions on how product and process knowledge is being captured and transferred, and more importantly, how is the knowledge being utilized to drive continuous improvements and sustain further advancements for this therapeutic class.

The workshop program consists of sessions covering a variety of topics related to Prior Knowledge from research, development, manufacturing and regulation.  Through presentations, case studies and panel discussions, workshop participants will learn the latest trends in the application of Prior Knowledge to monoclonal antibodies.  In addition to the planned sessions, the program will provide abundant opportunities for networking and exchange of ideas with regulators and industry leaders.  We look forward to welcoming you at the workshop in Spain!

The Co-Chairs,

Michael de Felippis, PhD., Eli Lilly, Chair
Martijn van de Plas, PhD., Medicines Evaluation Board, Chair

More information coming soon.


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

Tuesday, 27 November 2018

Welcome: Opening Remarks & Introductions
Falk Klar, PDA Europe
Martijn van der Plas, Workshop Chair, Medicines Evaluation Board
Michael De Felippis, Workshop Chair,Eli Lilly

09:15 - 09:45
Keynote: Regulatory Perspective on Prior Knowledge
Martijn van der Plas, Medicines Evaluation Board

09:45 - 12:45
Session 1: Regulatory Updates
Moderator: Martijn van der Plas, Medicines Evaluation Board

Microbial Control Strategies in the Manufacturing of Monoclonal Antibodies: Lessons Learned and Moving Forward
Patricia Hughes, US FDA

Regulatory Updates on Biological Medicinal Products
David Pérez Caballero, AEMPS

10:45 – 11:15
Coffee Break, Poster Session & Exhibition

The European Pharmacopoeia Approach to Monoclonal Antibodies
Emmanuelle Charton, EDQM

Industry Perspective on Product Specific Monographs
Barry Cherney, Amgen

Panel Discussion with Regulatory Representatives
David Pérez Caballero, AEMPSr
Patricia Hughes, US FDA
Emmanuelle Charton, EDQM
Mihaela Buda, EDQM
Steffen Groß, Paul-Ehrlich-Institut
Martijn van der Plas, Medicines Evaluation Board
Barry Cherney, Amgen

12:45 – 13:45
Lunch Break, Poster Session & Exhibition

13:45 – 15:30
Session 2: Bioassays – Trends, Development and Expectations
Moderator: Mihaela Buda, EDQM

Regulatory Perspective on Bioassays
Mihaela Buda, EDQM

International Standards for Bioassay Calibration
Sandra Prior, NIBSC Speaker

Stability Indication of Bioassays
Gael Debauve, UCB Speaker

Q&A, Discussion

15:30 – 16:00
Coffee Break, Poster Session & Exhibition

16:00 – 18:00
Session 3: Drug Products, Formulation and Delivery
Moderator: Susanne Joerg, LONZA

Challenges of Low Dose Administration MABEL Dosing Approaches)
Monika Geiger, LONZA

A QbD Approach to Formulation Robustness
Christine Wurth, Roche

Innovation Drug Delivery Systems for Biopharmaceuticals
Thomas Schönknecht, SHL Group

Panel Discussion

End of Conference Day 1

Networking Event

Wednesday, 28 November 2018

Martijn van der Plas, Workshop Chair, Medicines Evaluation Board
Michael De Felippis, Workshop Chair,Eli Lilly

09:05 – 10:30
Session 4: Process Development and Manufacturing
Moderator: Brian Mullan, Novartis

A Systematic Approach to Control System Updates of Established Products
Jan Pollmann, Roche

Manufacturing a Therapeutic Fab for High Concentrations - Filtration and Viscosity Challenges
Marc Pompiati, Roche

Application of ‘-Omics’ Technologies in MAbs Manufacturing
Niall Barron, University College Dublin

Q&A, Discussion

10:30 – 11:00
Coffee Break, Poster Session & Exhibition

11:00 – 13:00
Session 5: Control Strategies
Moderator: Michael De Felippis, Eli Lilly

Use of Prior Knowledge in Establishing Control Strategies
Barbara Rellahan, Amgen

Leveraging the Learnings of 10 Years of Developing Control Strategies Post ICH Q8 Part II
Felix Kepert, Roche

Application of Prior Knowledge to Drug Substance Process Development
Theresa Ahern, Eli Lilly

Q&A, Discussion

13:00 – 14:00
Lunch Break, Poster Session & Exhibition

14:00 - 15:00
Session 6: Post-Approval Life Cycle Management
Moderator: Juan Gimenez, Genentech/Roche

Can ICH Q12 Unlock Manufacturing Innovation?
Ursula Busse, Novartis

QRM Application to Biopharma Operations in the Q12 Era
Jose Menezes, 4Tune Engineering

Q&A, Discussion

p>15:00 – 15:30
Coffee Break, Poster Session & Exhibition


15:30 – 16:30
Closing Plenary: Biosimilar Variations & Biosimilar Product Development
Moderator: Steffen Gross, Paul-Ehrlich-Institut

Biosimilar Development
Michelle Frazier, Coherus BioScience

Structure-function Relationships for GP2015/Erelzi
Robert Mayer, Novartis

Q&A, Discussion

End of Conference and Farewell
Falk Klar, PDA Europe
Martijn van der Plas, Workshop Chair, Medicines Evaluation Board
Michael De Felippis, Workshop Chair,Eli Lilly

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.


Calle Dr. Pedro de Castro 1
41004 Sevilla
Tel: +34 912 76 47 47
Hotel Website

Located in the heart of Seville opposite the Parque de Maria Luisa and Plaza España and very close to the University (Old Tobacco Factory), the Alcazar, the Barrio de Santa Cruz district, the Cathedral and the Archive of the Indies, the new Meliá Sevilla is the perfect choice for your business and leisure trips, thanks to its excellent location in the city centre, its fully equipped and comfortable facilities and the quality of its services.

Completely refurbished, the hotel offers a stunning outdoor pool with views of Plaza España and a spectacular Congress and Convention Centre. All the rooms at the new Meliá Sevilla are outward facing, comfortable and bright.

The hotel’s Mosaico restaurant serves an international breakfast buffet. There is also a poolside snack bar and a chic cocktail lounge, Elyxr.

PDA Europe has reserved a limited number of rooms until the 26th September 2018

Book Your Room for the PDA Group Rate

Single Room € 95 per night; 10% VAT, additional taxes and service charges will apply *
Double Room € 106 per night; 10% VAT, additional taxes and service charges will apply*

*Rates are per room and night, including the following services and benefits free of charge:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)

How to Get There

Seville Airport– SVQ
Airport Phone: +34 954 44 90 00
Hotel Direction: 11.8 km
The airport shuttle service is upon request for €25 per vehicle one way.


Parking available upon request at the registration desk.