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11th Workshop on Monoclonal Antibodies

Nov 27 - Nov 28, 2018
Seville, Spain

Applications of Prior Knowledge to Monoclonal Antibody Discovery, Development and Commercialization

  • Conference
  • Europe
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


  • 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

Additional Information

  • Who Should Attend

    More information coming soon.

Got a Question? We have answers

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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
Seville, Spain


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.


How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.


Registration Fees

Regular Price

3 Ways to register

Please remember to log in if you are a member of PDA already!

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).

Registration Fees

Are you entiteld to receive a discount? Need Help?


By 14 October 2018
1.395 Euro

After 14 October 2018
1.595 Euro


By 14 October 2018
1.695 Euro

After 14 October 2018
1.895 Euro

Govern./Health Authority/Academic

By 14 October 2018
700 Euro

After 14 October 2018
800 Euro

All fees given in Euro and excluding VAT (21%)


Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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