PDA BioManufacturing Conference 2025

Biomanufacturing Capabilities & Strategies – What is Next?

23 - 24 Sep 2025
DoubleTree by Hilton Rotterdam Centre
Rotterdam, The Netherlands

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Explore the Future of Manufacturing at the PDA Biomanufacturing Conference 2025
Biomanufacturing Capabilities & Strategies – What Is Next?

On behalf of PDA and the Scientific Program Planning Committee, we are excited to welcome you to the PDA Biomanufacturing Conference 2025, taking place in Rotterdam, The Netherlands, from 23–24 September 2025. As a key part of PDA’s commitment to advancing pharmaceutical manufacturing, this conference sets the stage for critical discussions on the future of biomanufacturing.

Biomanufacturing Capabilities & Strategies – What Is Next?
This year’s theme challenges us to look ahead with confidence, exploring how new strategies, technologies, and regulatory frameworks can shape the next generation of biomanufacturing.
Exclusively at the conference, we are looking at how sustainability can be enabled through digital integration.
With growing complexity in modalities, heightened global demands, and increasing focus on sustainability and digital integration, the future of biomanufacturing demands agility, innovation, and collaboration.

The 2025 agenda brings together global experts from regulatory bodies, industry, and academia to share their experience and perspectives on upcoming developments in biomanufacturing capabilities and strategies. From evolving regulatory guidance to technological innovation, the conference offers a platform to learn, engage, and co-create the path forward.

What Makes This Conference Unique?

Collaboration is at the heart of this conference. PDA continues to bring together regulators, academia, and industry in a unique, non-competitive forum that fosters transparent dialogue and mutual understanding. This setting encourages open exchange across all sectors to shape the future of biomanufacturing together.

We invite you to become part of this collaborative dialogue. Your active participation is encouraged, this event is designed to make it easy for attendees to share questions, challenges, and insights directly with speakers and fellow participants. Through interactive formats and inclusive discussions, every voice contributes to meaningful progress.

Start your experience early! We invite you to attend the PDA Shaping the Future of Vaccines Workshop 2025, held on 22 September, the day before the main conference. In collaboration with Vaccines Europe, this one-day workshop brings together regulators, manufacturers, and global health stakeholders to explore innovation, policy, and strategy shaping the future of vaccines.

What to Expect

The conference features a thoughtfully curated agenda covering key aspects of the biomanufacturing lifecycle:

  • Regulatory Insights and Frameworks: Gain early understanding of key CHMP/ICH guidance updates on CMC and learn how current and upcoming regulatory initiatives are shaping the future of biomanufacturing in Europe and beyond.
  • Sustainability Through Digitalization: Understand how digital transformation can enable more sustainable and efficient biomanufacturing processes, with practical examples and forward-looking concepts.
  • Manufacturing Innovation: Explore Europe’s leading role in manufacturing innovation and competitiveness, with expert views on how the region is driving change.
  • Overcoming Manufacturing Challenges: Dive into recent industry activities tackling persistent manufacturing challenges, from process robustness to technology integration.
  • Advances in Analytical Methodologies: Discover how analytical innovation is supporting better process understanding, control, and product quality.
  • New Modalities and Future Medicines: Stay informed on how innovation in new modalities is influencing future therapeutic development and manufacturing.
  • Accelerating Access: Learn how the EMA supports innovation and explore current development and regulatory approaches aimed at accelerating patient access to medicines.
Why Attend the Conference?

This two-day event offers deep industry insights and valuable networking opportunities:

  • Strategic Vision: Understand how current and future strategies are reshaping global biomanufacturing and regulatory alignment.
  • Actionable Knowledge: Gain practical insights through real-world case studies, panel discussions, and interactive formats.
  • Meaningful Engagement: Join extended networking sessions, including roundtables, plenary discussions, and Q&A sessions designed to foster collaboration and open dialogue.
  • Community Building: Be part of a growing community of professionals committed to delivering excellence and innovation in biomanufacturing.

We look forward to inspiring dialogue, idea exchange, and the formation of new partnerships that will define the future of biomanufacturing. Join us in Rotterdam for two days of impactful discussions, shared learning, and future-focused collaboration.

Register today and help shape what’s next in biomanufacturing.

Sincerely,

The Co-Chairs

Sabine Hauck, Consultant
Maria Papathanasiou, Imperial College London

Agenda

Discover What's Happening Each Day
Download Full Schedule Please note that this file may take some time to download depending on your internet connection. Thank you for your patience.
Agenda is subject to change. *
Tue 23 Sep Wed 24 Sep Workshop
Tuesday, 23 September

CEST Daylight Time (UTC +2:00)

Wednesday, 24 September

CEST Daylight Time (UTC +2:00)

PDA Shaping the Future of Vaccines Workshop 2025
22 Sep
Learn More and Register

Activities and Networking Opportunities

Connect and Collaborate with Purpose

Take the opportunity to connect with like-minded professionals, industry peers, and new contacts in a relaxed and inspiring setting! Our networking event takes place on board Vessel 11 - an iconic red lightship moored right in the heart of Rotterdam!

Date: 23 September 2025
Time: 18:30-21:00 CEST
Location: Vessel 11 - Wijnhaven T/o 101, 3011 Wn Rotterdam

Join us and experience networking in Rotterdam!
Individual travel to the location.

Program Planning Committee

The Team Behind the Event's Agenda

  • Pepijn Burgers, PhD

    JnJ Innovative Medicine

    Scientific Director Biologics AD

    Read Bio

  • Cristiana Campa, PhD

    GSK

    Technical R&D Advisor

    Read Bio

  • Michael R. De Felippis, PhD

    Eli Lilly and Company

    Senior Vice President - Research Bioproduct Research and Development

    Read Bio

  • Josh Eaton, MS

    PDA

    Senior Director, Scientific and Regulatory Affairs

    Read Bio

  • Sebastian Groel, PhD

    Daiichi Sankyo Europe

    Manager Formulation Technology

    Read Bio

  • Veronika Jekerle, PhD

    European Medicines Agency

    Head of Pharmaceutical Quality, Human Medicines

    Read Bio

  • Falk Klar, PhD

    Parenteral Drug Association

    General Manager, Vice President Europe

    Read Bio

  • Julian H. Lenger, PhD

    AbbVie

    Head of Laboratory in Parenteral Manufacturing Sciences

    Read Bio

  • Caroline Lynar

    Parenteral Drug Association

    Manager Programs & Events

  • Orla McCarthy, MPharm

    Merck Sharp & Dohme

    Associate Principal Scientist International CMC EU/EEMEA

    Read Bio

  • Thomas Zahel, PhD

    Körber Pharma Austria GmbH

    Head of Innovation

    Read Bio

Promotions and Press

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Location and Travel

Venue Details and Accommodations

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.

DoubleTree by Hilton Rotterdam Centre

Leuvehaven 80
Rotterdam, The Netherlands 3011 EA The Netherlands
Make a Reservation Online

PDA recommends the reservation at the following hotel

DoubleTree by Hilton Rotterdam Centre
Leuvehaven 80
3011 EA, Rotterdam
The Netherlands

PDA Europe has reserved a limited number of rooms until 21 July 2025.

Book your room at the PDA Group Rate using the above-mentioned reservation button.

How to Get Here
By Air From Rotterdam The Hague Airport (RTM) The hotel is about 7 km from the airport. Taxi: Takes around 15–20 minutes. Public Transport: Take Bus 33 to Rotterdam Central Station, then Tram 7 (direction Willemsplein) and get off at Leuvehaven, right by the hotel. The hotel is about 60 km from Schiphol. Train: Take the Intercity Direct from Schiphol to Rotterdam Central Station (~25 minutes). From there, take Tram 7 (direction Willemsplein) to Leuvehaven, right by the hotel. Taxi: Takes around 50–60 minutes, depending on traffic.
By Car The hotel is centrally located and easily accessible from major roads. On-site parking is available in the hotel's underground garage.
By Other Options Train: Rotterdam Central Station is just a 10-minute tram ride away. Tram: The Leuvehaven tram stop is right in front of the hotel, served by Tram 7.
Area Attractions
  • Markthal Rotterdam (10-minute walk)
  • Erasmus Bridge (5-minute walk)
  • Cube Houses (15-minute walk)
  • Delfshaven (15-minute tram ride)

Did you know? Rotterdam is known as the "Manhattan on the Maas", with a skyline filled with modern architectural wonders!

Registration

Pricing Options
Register for the PDA BioManufacturing Conference 2025 and benefit from a reduced price for the PDA Shaping the Future of Vaccines Workshop 2025, saving €230!
To claim your discount, please reach out to registration-europe@pda.org.

Standard Registration

Member Price

€2,390

GovernmentMember Only

€1,200

Health AuthorityMember Only

€1,200

Early Career ProfessionalMember Only

€1,200

StudentMember Only

€1,200

AcademicMember Only

€1,200

Non-Member

€2,690

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

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 registration-europe@pda.org 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.

Presenters

Meet the Experts
  • Simon Baukmann

    Simon Baukmann

    Institute for Separation and Process Technology, TU Clausthal

    Research Associate

    Academic Panelist
    Academic Presenter
    Read Bio
  • Thomas De Beer, PhD

    Thomas De Beer, PhD

    Ghent University

    Professor

    Academic Panelist
    Academic Presenter
    Read Bio
  • Daniel Demminger, Dr

    Daniel Demminger, Dr

    Coriolis Pharma Research GmbH

    Senior Scientist

    Panelist
    Presenter
    Read Bio

  • Brian Dooley

    Regulatory Panelist
    Regulatory Presenter
  • Josh Eaton, MS

    Josh Eaton, MS

    PDA

    Senior Director, Scientific and Regulatory Affairs

    Committee Member
    Panelist
    Presenter
    Read Bio
  • Helerin Eiche, PhD

    Helerin Eiche, PhD

    State Agency of Medicines (Estonia)

    Quality Assessor of Biological Medicinal Products

    Regulatory Panelist
    Read Bio
  • Steffen Gross, PhD

    Steffen Gross, PhD

    Paul-Ehrlich-Institute

    Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Pieter Jan Haas, PhD MD

    Pieter Jan Haas, PhD MD

    University Medical Center Utrecht

    Medical Microbiologist

    Academic Panelist
    Academic Presenter
    Read Bio
  • Daniel Holý, Ing

    Daniel Holý, Ing

    State Institute for Drug Control (Czechia)

    Quality Assessor of Biological Medicinal Products

    Regulatory Panelist
    Read Bio

  • Divya Jain

    Panelist
    Presenter
  • Veronika Jekerle, PhD

    Veronika Jekerle, PhD

    European Medicines Agency

    Head of Pharmaceutical Quality, Human Medicines

    Committee Member
    Regulatory Presenter
    Read Bio
  • Olga Labovitiadi, PhD

    Olga Labovitiadi, PhD

    JnJ Innovative Medicines Drug product Development and Delivery

    Scientific Associate Director

    Panelist
    Presenter
    Read Bio
  • Cillian McCabe, PhD, Fellow of the Royal Society of Chemistry

    Cillian McCabe, PhD, Fellow of the Royal Society of Chemistry

    Eli Lilly and Company

    Director Technical Services Manufacturing Sciences

    Panelist
    Presenter
    Read Bio
  • Colleen O'Brien, MS

    Colleen O'Brien, MS

    Gerresheimer

    Strategy and Technical Affairs

    Panelist
    Presenter
    Read Bio
  • Ina Pahl

    Ina Pahl

    Sartorius Stedim Biotech GmbH

    Senior Scientist

    Panelist
    Presenter
    Read Bio
  • Maria Papathanasiou, PhD

    Maria Papathanasiou, PhD

    Department of Chemical Engineering, Imperial College London

    Associate Professor (UK Senior Lecturer)

    Academic Panelist
    Academic Presenter
    Co-Chair
    Moderator
    Read Bio
  • Mónica Perea-Vélez, MSc, PhD

    Mónica Perea-Vélez, MSc, PhD

    GSK

    CMC Advocacy and Policy Director

    Panelist
    Presenter
    Read Bio
  • Olga Rovira, MSc

    Olga Rovira, MSc

    CEPI

    Regulatory Affairs Senior Consultant

    Panelist
    Presenter
    Read Bio
  • Daniela Stranges, PhD

    Daniela Stranges, PhD

    GlaxoSmithKlein (GSK)

    Director

    Panelist
    Presenter
    Read Bio

  • Gabriele Vigani

    Fedegari Group

    Global Product Manager, Digital Solutions

    Panelist
    Presenter
    Read Bio
  • Bruce Yu, PhD

    Bruce Yu, PhD

    University of Maryland School of Pharmacy

    Professor

    Academic Panelist
    Academic Presenter
    Read Bio

Sponsors

Sponsors and Collaborators

Sponsorship and Exhibit Opportunities are available!

For more information about exhibit and sponsorship opportunities, please contact:

Christopher Leisterer-Härtig
Assistant Director Events & Exhibition
Email

Exhibitors

Exhibitors and Innovators
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Contact

Program Inquiries
Caroline Lynar
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
training-europe@pda.org
Registration Customer Care