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2022 PDA BioManufacturing Conference

Sep 20 - Sep 21, 2022
Amsterdam, The Netherlands

Biopharmaceutical Solutions to Prepare for Healthcare Challenges

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  • Europe
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Program Highlights

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See you in Amsterdam!

Overview

Dear Colleagues,

We welcome you to the next 2022 PDA BioManufacturing Conference! 

This year, the Scientific Program Planning Committee and the PDA have joined forces with the Lyophilization Conference to offer a full experience including emerging trends on biomanufacturing and regulatory focus areas. We will come together as a 3 – track conference face-to-face in Amsterdam / The Netherlands on 20-21 September 2022. 

Over the last years, we have seen a tremendous acceleration in all aspects of biopharmaceutical development, due to the health emergency, which revealed many opportunities for exploring new technologies, development approaches and regulatory frameworks to support rapid access of vaccines and biotherapeutics as well as sustainable life cycle management. The conference will provide the opportunity to discuss all these aspects: the theme of this edition will be Biopharmaceutical Solutions to Prepare for Healthcare Challenges.

The 2022 Biomanufacturing conference will emphasize topics including product, process and analytical development, aseptic manufacturing, supply chain challenges, lifecycle strategies, new technologies, environmental sustainability, regulatory approaches.

You will have the opportunity to expand your network, interacting with professionals from Industry, Academia, Research Institutes and Health Agencies.

We look forward to seeing you in September!

Sincerely, 
The Chairs

Cristiana Campa, GSK Vaccines 
Raf De Dier, Janssen

SCIENTIFIC PROGRAM PLANNING COMMITTEE

  • Cristiana Campa, GSK Vaccines (Chair)
  • Raf De Dier, Janssen (Chair)
  • Marta Antunes, MSD
  • Thomas Beutler, GEA Lyophil
  • Michael De Felippis, Eli Lilly and Company
  • Thierry Gastineau, Sanofi
  • Sabine Hauck, Leukocare
  • Susanne Joerg, ten23 health 
  • Julian Lenger, Bayer 
  • Yves Mayeresse, GSK 
  • Arnaud Paris, BioMerieux
  • Elisabeth Vachette, Sartorius 
  • Josh Eaton, PDA
  • Falk Klar, PDA 
  • Sabine Hartmann, Manager Programs & Events, PDA
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Agenda

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  • Day 1
  • Day 2

  • Tuesday, 20 September 2022

    09:00

    Welcome and Introduction
    Falk Klar, PDA Europe
    Cristiana Campa, GSK
    Raf De Dier, Janssen

    Opening Plenary: Biopharmaceutical Solutions to Prepare for Healthcare Challenges
    Moderator: Cristiana Campa, GSK & Raf de Dier, Janssen

    EMA CMC toolbox on early access: applicability to COVID-19 and beyond
    EMA

    CMC Innovations to Achieve CEPI's 100 Days Mission – Lessons Learned from COVID-19 and Plans for the Future
    CEPI

    10:15 - 10:45 | Coffee Break, Poster Session & Exhibition

    Current ICH Topics and Specification Setting Strategies
    Medicine Products Agency Sweden

    Q&A; Panel Discussion

    12:00 - 13:00 | Lunch Break, Exhibition & Interactive Poster Session

    Session 1A: Acceleration & Leanings from Pandemics
    Moderator: Thierry Gastineau, Sanofi

    Strategies for Rapid Development and Commercialization of MAb Therapies for COVID-19
    GSK

    How to Accelerate the Supply of Vaccines to all Populations Worldwide - A Regulatory Perspective
    Merck

    How has Biomanufacturing Changed from a Supply Chain Integrity Standpoint Because of the Pandemic
    Rx-360

    Q&A Discussion

    Session 1B: Facilities
    Moderator: Yves Mayeresse, GSK

    Aseptic Processing - A Paradigm Shift
    PM Group

    Solutions to Multi-Modal, Flexible, and Sustainability Facility Design
    DPS Group

    Designing Flexible and Multi-Entity RNA Production Facilities
    DPS Group

    Q&A Discussion

    Session 1C: Lyophilization – Process & Characterization
    Moderator: Julian Lenger, Bayer

    Process Modeling and Process Analytical Technology for Primary Drying Design and Optimization
    TU Clausthal

    The Effect of Nesting and Neighboring Vials in Freeze-Drying
    LMU Munich

    Q&A Discussion

    14:30 - 15:00 | Coffee Break, Poster Session & Exhibition

    Session 2A: Vaccine Platforms and Control Strategies
    Moderator: Sabine Hauck, Leukocare

    Quality by Digital Design for RNA Vaccine and Therapeutic Production
    The University of Sheffield

    Platform to Accelerate the Development of Vaccines Against Bacterial Pathogens
    GSK

    How Integrity Testing of Single-Use Systems in Vaccine Manufacturing Can Help to Secure the Fast and Reliable Availability of Vaccines During a Pandemic – and Beyond
    Sartorius

    Q&A Discussion

    Session 2B: Sustainability
    Moderator: Thierry Gastineau, Sanofi

    Designing for Patients and the Planet: Sustainable Solutions for Pharmaceutical Products
    Johnson & Johnson

    Sustainable Innovative Solutions for a New Agile Manufacturing facility
    Sanofi

    Collaboration, Standardization, and Innovation – Steppingstones to Net Zero in Biopharma
    PM Group & Sartorius

    Q&A Discussion

    Session 2C: Sustainability
    Moderator: Thomas Beutler, GEA Lyophil

    GMP-Ready Continuous and Controlled Freeze-Drying
    Ghent University & Rhea Vita

    Evolution of Vision Technologies for Contaminants Characterization: How to Improve the Detection Rate and Reduce False Reject in Lyophilized Products Inspection
    S.P.A.M.I. srl

    Shelf Temperature Mapping- Easy Test
    or Miracle?
    Bayer

    Q&A Discussion

    16:30 - 17:00 | Break, Poster Session & Exhibition

    Session 3A: Single Use Systems
    Moderator: Elisabeth Vachette, Sartorius

    Single-Use Bioprocess Systems Sterilization by X-Ray: Challenges, Interchangeability, and Flexibility Outcomes
    Sartorius

    End-to-End Single-Use Manufacturing at Pilot Plant for Early Development Clinical Material
    Janssen

    Extractables and Leachable from Single-Use Systems and Their Assessment in Cell and Gene Therapy Applications
    Sartorius

    Q&A Discussion

    Session 3B: Interest Group Vaccines
    Moderator: Michael De Filippis, Eli Lilly & Company

    Welcome from the Session Chairs
    Michael De Filippis, Eli Lilly & Company
    Andrew Chang, Novo Nordisk

    Overview of PDA Vaccine Technical Report
    Consultant

    Vaccine Lifecycle Management: Regulatory Perspective
    US FDA

    Lessons Learned from COVID-19 Pandemic on Vaccine Lifecycle Management
    AstraZeneca

    Vaccine Case Studies: Identification of Established Conditions (ECs) and Justification for Reporting Categories When Make Changes to the ECs
    Sanofi

    Q&A Discussion

    18:30 | End of Conference Day 1 and Networking Event

  • Wednesday, 21 September 2022

    08:00 - 09:00 AM I Early Career Professionals - Morning coffee chat with the Old Schools
    Meet our PDA veterans at the conference foyer and get first-hand information on how you can expand your network, boost your career and participate in shaping the future of our industry!

    Cristiana Campa, GSK
    Julian Lenger, Bayer
    Falk Klar, PDA Europe

    09:00

    Welcome Back & Summary Day 1
    Cristiana Campa, GSK
    Raf De Dier, Janssen

    Session 4A: Innovations in Formulation & Drug Product Manufacturing
    Moderator: Raf De Dier, Janssen

    Quickly by Design: How New Methods Reshape the Selection and Formulation Development of Novel Therapeutic Proteins
    Ghent University

    Overcoming Challenges in Co-Formulation of Proteins with Contradicting Stability Profiles – EPO plus G-CSF
    A. Menarini Research & Service Business GmbH

    Model Predictive Control for Automated Biologics Drug Product Manufacturing
    Janssen

    Q&A Discussion

    Session 4B: ICH Upcoming Topics - Stability & Specification
    Moderator: tba

    Using Stability Prior Knowledge From ‘Like-Molecules’ to Determine Shelf-Life
    Amgen

    Accelerated Stability Study: Kinetic or Statistical Models?
    GSK

    Specifications Setting for Biopharmaceuticals in Accelerated Scenarios
    GSK

    Q&A Discussion

    Session 4C: Quality Control Methods
    Moderator: Marta Antunes, MSD

    Superior Methods for the Assessment of Particulate Matter Risks when Applying Single-Use Systems: Moving Beyond the Force-Fit of USP
    Sartorius

    Which Sustainable Innovative Solutions for a New Agile Manufacturing Facility?
    Obviotec

    Q&A Discussion

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

    Session 5A: Track A – MAb New Trends
    Moderator: Elisabeth Vachette, Sartorius

    Strategic Modernization of a Commercial Monoclonal Antibody Process by the Introduction of a Next Generation Protein A Resin
    Eli Lilly & Company

    Process Intensification and Connected Processing for Robust, Cost-Effective, and Fast Manufacturing of Monoclonal Antibodies
    Sartorius

    Q&A Discussion

    Session 5B: Comparability Strategies & Technical Transfers
    Moderator: Marta Antunes, MSD

    Comparability – How Similar is Similar? Lessons Learnt from Experience with Biosimilars
    HPRA

    Using Quality by Design to Accelerate the Biopharmaceutical Product Development Lifecycle: A Case Study
    GSK

    Q&A Discussion

    Session 5C: Lyophilization Product Considerations
    Moderator: Yves Mayeresse, GSK

    Protein Stability in the Freeze Concentrated Solution
    Coriolis Pharma

    Investigation on Solution Creeping in Vials after Filling -A Case Study
    Boehringer Ingelheim

    Q&A Discussion

    12:25 - 13:10 | Lunch Break, Poster Session & Exhibition

    13:10 - 13:40 | Poster Walk

    Closing Plenary: Digitalization & Innovation
    Moderator: Sabine Hauck, Leukocare

    Regulatory Perspective on Model-Based Approaches to Biomanufacturing
    CBG meb Netherlands

    Transformation to the Laboratory of the Future: Automation Technology, Digitalization, and Artificial Intelligence
    Lonza

     

    14:45 - 15:15 | Coffee Break, Poster Session & Exhibition

    Sustainability in Quality Control of Vaccines: Applying the 3R’s principle and implementing the 4th R.
    Sciensano Belgium

    Closing Panel Discussion with Key Speakers

    Conference Summaries by the Chairs
    Cristiana Campa, GSK
    Raf de Dier, Janssen

    Closing Remarks & Farewell
    Falk Klar, PDA

    16:30 | End of Conference

    The agenda is subject to change without notice, Speakers are invited, pending confirmation

Additional Information

  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

Got a Question? We have answers

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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.

Hilton Amsterdam

Apollolaan 138
Amsterdam, The Netherlands

Make a Reservation
Hilton Amsterdam
  • Accommodations

    Rate: Single Room € 219 per night*
    Rate: Double Room € 239 per night*

    * 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)
    • VAT, Taxes and Service will apply

    Make your reservations as early as possible to guarantee your room. PDA Europe has reserved a limited number of rooms until 01 July 2022.

    Rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

  • Amenities
    Canalside hotel with award-winning restaurant, 15 minutes from airport and right next to the Van Gogh Museum.

How to Get Here

By Air

The international airport of Amsterdam is "Schiphol" located 66 km away from the hotel and conference space.

By Car

Parking is available on site, € 45.00 per day. No valid parking.

Other Options

From international airport "Schiphol" you can take the bus every 8 minutes, taking approximately 35 minutes to the station "Emmastraat". From here it is only a 7 min walk by foot.

Directions

Registration Fees

Early Registration
Registration Type Price by 24 July 2022
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €845
Early Career Professional (Member) €845
Regular Registration
Registration Type Price after 24 July 2022
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €945
Early Career Professional (Member) €945

* 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.

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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Contact

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Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
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Tel: +1 (301) 656-5900 ext. 115
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