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2019 BioManu

BioManufacturing

Sep 03 - Sep 04, 2019
Munich, Germany

  • Conference
  • Europe
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Program Highlights

Regulatory Speakers Confirmed!

Hear updates from:

  • European Medicines Agency
  • European Directorate for the Quality of Medicine & HealthCare
  • BASG, Austrian Agency for Health and Food Safety
  • Danish Medicines Agency
  • Dutch Medicines Evaluation Board
  • Swedish Medicines Agency
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Overview

Dear Colleagues,

We are proud to present the inaugural conference 2019 PDA Europe BioManufacturing, 3-4 September 2019 in Munich/Germany.

Over the past 40 years, biopharmaceutical products have become increasingly important medicinal tools for human and animal healthcare. Recognizing the critical role that manufacturing plays in enabling pharmaceutical innovation and the important synergies connecting different product platforms, PDA Europe will be introducing its inaugural Bio-Manufacturing Conference in Munich/Germany. The conference will provide a forum to present innovative approaches and discuss hot topics related to product, process and analytics spanning a variety of biopharmaceutical product classes.

Experts from industry, academia and regulatory agencies are warmly welcomed to attend this unique event and join the exchange and the abundant networking opportunities. On behalf of PDA Europe and the Scientific Program Planning Committee, we look forward to welcoming you to the beautiful city of Munich!

Sincerely,
The Chairs,

Cristiana Campa, PhD,
GSK Vaccines

Michael De Felippis, PhD,
Eli Lilly & Co

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Agenda

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  • Day 1
  • Day 2

  • Tuesday, 3 September 2019

    9:00 – 9:10
    Welcome and Introduction
    Kerstin Wilken, PDA Europe
    Cristiana Campa, GSK Vaccines,Conference Chair
    Michael de Felippis, Eli Lilly, Conference Chair

    9:20 - 11:00
    Opening Plenary: Updates in Biomanufacturing
    Moderator: Cristiana Campa, GSK Vaccines

    9:20 - 9:50
    Keynote: Reinventing Biopharma through Digital and Analytics
    Alvaro Carpintero, McKinsey & Company

    9:50 - 10:35
    Regulatory Perspectives on Accelerated Access and a Summary of the EMA/FDA 2018 Workshop on Support to Quality Development in Early Access Approaches
    Mats Welin, Medical Products Agency Sweden
    Dolores Hernan, European Medicines Agency

    10:35 - 11:00
    Q&A, Discussion

    11:00 - 11:30
    Coffee Break, Poster Session & Exhibition

    Transition to Two Parallel Tracks

    11:30 - 13:00
    Session 1A: Accelerated Access
    Moderator: Martijn van der Plas, Dutch Medicine Evaluation Board

    11:30 - 11:55
    Challenges for Registration and Opportunities to Increase Alignment of Requirements in Emerging Countries
    Mic McGoldrick, MSD

    11:55 - 12:20
    CMC Criteria for Accelerated Access of Vaccines
    M. Amin Khan, GSK Vaccines

    12:20 - 13:00
    Panel Discussion
    Mic McGoldrick, MSD
    M. Amin Khan, GSK
    Mats Welin, Swedish Medical Products Agency
    Dolores Hernan, European Medicines Agency

    Session 1B: Considerations on Facility Design
    Moderator: Elisabeth Vachette, Sartorius Stedim

    11:30 - 11:55
    The Right Facility Setup Consideration
    Niels Guldager, NNE

    11:55 - 12:20
    Engineering and Facility Design Challenges in Novel Therapeutic Vaccines and New Generation Biologics
    Indu Conley, DPS Group

    12:20 - 12:45
    Case Study: Introduction of a New Highly Potent Biopharmaceutical Product into an Existing Facility
    Morcos Loka, Minapharm

    12:45 - 13:00
    Q&A, Discussion

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

    Transition to Three Parallel Tracks

    14:00 - 15:45
    Session 2A: ICH Q12 Guideline
    Moderator: Florence Wauters, MSD

    14:00 - 14:25
    An Update on ICH Q12
    Nanna Kruse, Danish Medicines Agency

    14:25 - 14:50
    ICH Q12 Implementation from an Industry Perspective with a Focus on Established Conditions
    Mihai Bilanin, GSK Vaccines
    Marcello Colao, GSK Vaccines

    14:50 - 15:15
    Post Approval Changes in Biologics Manufacturing - a Practical Assessment from a Supplier's Perspective
    Janmeet Anant, Merck KGaA

    15:15 - 15:45
    Q&A, Discussion

    14:00 - 15:45
    Session 2B: New Modalities & Novel Vaccines
    Moderator: Susanne Joerg, LONZA

    14:00 - 14:25
    Challenges in the Development of Biologics - A Regulator's Perspective
    Wilhelm Herock, BASG, Austrian Agency for Health and Food Safety

    14:25 - 14:50
    Manufacture of New Modalities
    Uwe Gottschalk, LONZA

    14:50 - 15:15
    Fighting Pathogens and Toxins with Human and Human-like Recombinant Antibodies
    Michael Hust, Technical University Braunschweig

    15:15 - 15:45
    Q&A, Discussion

    14:00 - 15:45
    Session 2C: Approaches to Microbial Control and Sterilization Methods
    Moderator: Walid El-Azab, STERIS

    14:00 - 14:25
    Advancing QC Microbiology Modernization Through Cross-industry Collaboration
    Caroline Duignan, GSK

    14:25 - 14:50
    VH2O2 Low Temperature Terminal Sterilization Process and Technology: Validation Requirements and Methods, and a Case Study on Critical Process Control and Monitoring
    Juha Mattila, STERIS

    14:50 - 15:15
    How to make the Optimal Choice for the Final Sterilization of Pharmaceutical Products
    Annick Gillet, Sterigenics

    15:15 - 15:45
    Q&A, Discussion

    15:45 - 16:15
    Coffee Break, Poster Session & Exhibition

    Parallel Tracks

    16:15 - 18:00
    Session 3A: Continuous Manufacturing and ICH Q13
    Moderator: Florence Wauters, MSD

    16:15 - 16:40
    ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products – Where Are We with This Guidance?
    Ganapathy Mohan, MSD

    16:40 - 17:05
    Continuous Downstream Processing: Comparability and Regulatory Risks
    Klaus Kaiser, Bayer

    17:05 - 18:00
    Q&A, Discussion

    16:15 - 18:00
    Session 3B: From the Drug Substance to the Finished Product
    Moderator: Susanne Joerg, LONZA

    16:15 - 16:40
    The "Fate of Leachables" in Biopharmaceutical Downstream Processes
    Amin Hauk, Sartorius Stedim

    16:40 - 17:05
    Degradation of Excipients in Formulations
    Adithya Balasubramanian, LONZA

    17:05 - 17:30
    Investigation of Drug Product and Container-Closure Interactions: a Case Study of Diluent Containing Pre-filled Syringes
    Vivek Thakare, Novartis

    17:30 - 18:00
    Q&A, Discussion

    16:15 - 18:00
    Session 3C: Automation & Digitalization
    Moderator: Falk Klar, PDA Europs

    16:15 - 16:40
    Digital Twin of a Vaccine Process
    Sandrine Dessoy, GSK Biologics

    16:40 - 17:05
    Augmented Control of the BioManufacturing Processes
    Toni Manzano, Bigfinite

    17:05 - 17:30
    Big Data in BioManufacturing
    Per Vase, NNE

    17:30 -18:00
    Q&A, Discussion

    18:00
    End of Day 1 and Networking Event


  • Wednesday, 4 September 2019

    9:00 - 10:30
    Session 4A: Considerations for ICH Q2/Q14 and Advancements in Test Methodologies - Part 1
    Moderator: Félix Montero-Julian, BioMérieux

    9:00 - 9:25
    A Regulatory Perspective on Alternative Test Methods to Reduce Animal Testing
    Gwenaël Ciréfice, EDQM

    9:25 - 9:50
    Development of Innovative and More Precise Methods for Replacement of In Vivo Release Tests of Authorized Vaccines in The IMI VAC2VAC Project
    Marcel Hoefnagel, Dutch Medicines Evaluation Board

    9:50 - 10:15
    Applying a Next Generation Sequencing Workflow to Accelerate Biopharmaceutical Manufacturing Processes and Improve Safety
    Christoph Bredack, Genedata

    10:15 -10:30
    Q&A, Discussion

    9:00 - 10:30
    Session 4B: Quality by Design Enabled Control Strategy
    Moderator: Michael De Felippis, Eli Lilly

    The science and risk-based approaches to process and product development outlined in ICH Q8, Q9, Q10 and Q11 provide a framework for incorporating Quality by Design (QbD) principles into the commercialization of biopharmaceuticals. Published case studies, such as A-Mab and A-Vax, have further advanced application of these guidance documents by illustrating how control strategies for monoclonal antibodies and vaccines can be devised using QbD concepts. This session focuses on the application of QbD to enable control strategies offering both industry and regulator perspectives.

    9:00 - 9:25
    Engineering-Driven Application of Quality by Design to the GMMA Platform: Enabling the Production of Affordable and Effective Vaccines for Low- and Middle-Income Countries
    Zoltán Kis, Imperial College London

    9:25 - 9:50
    Phase Appropriate and Risk-based Design of a Bioburden and Sterilization Control Strategy for New Vaccines Candidates
    Giovanna Campanella, GSK Vaccines

    9:50 - 10:15
    Regulatory Perspective on Control Strategies
    Martijn van der Plas, Dutch Medicines Evaluation Board

    10:15 -10:30
    Q&A, Discussion

    9:00 - 10:30
    Session 4C: Interest Group Meeting Filtration
    - open to all -
    Sebastian Teitz, Asahi Kasei
    Michiel Rook, Global Consepts – Europe B.V.

    Take advantage of the open forum design approach offered by this focused Interest Group meeting. Hear presentations from leading experts and interact and discuss your experiences with colleagues in an open atmosphere. Share your opinion and enlarge your knowledge on Virus Safety and Filtration in interactive discussion rounds. Receive the latest information about activities of the Interest Group Filtration.

    9:00 - 9:25
    Welcome and Introduction

    Virus meets Microbial Filtration

    Filter Functionality in the Biopharmaceutical Industry

    Sebastian Teitz, Asahi Kasei
    Michiel Rook, Global Consept Europe B.V.

    9:25 - 9:50
    Worst case pressure conditions during filtration of pathogen sizes ranging from small virus to typical bacteria
    Mathias Siebner, Sartorius Stedim

    9:50 - 10:15
    Interactive Group Discussion

    Alternative Approaches to Segregation in Facility Design and Operation
    Kavita Ramalingam Iyer, GSK

    10:15 -10:30
    Final Discussion and Summary of the IG Meeting

    10:40 - 11:10
    Coffee Break, Poster Session & Exhibition

    11:10 - 12:30
    Session 5A: Considerations for ICH Q2/Q14 and Advancements in Test Methodologies – Part 2 (cont'd)
    Moderator: Felix Montero-Julian, BioMérieux

    11:10 - 11:40
    Revision of ICH Q2(R1) and new ICH Q14 Guidance - Opportunities for The Life Cycle Management of Analytical Procedures
    Christof Finkler, F. Hoffmann - La Roche

    11:40 - 12:10
    Replacing In Vivo Potency Testing with In Vitro Assays: Challenges and Expectations
    Barbara Capecchi, GSK Vaccines

    12:10 -12:30
    Q&A, Discussion

    11:10 - 12:30
    Session 5B: Water for Injection: Implementation of the New Guideline
    Moderator: Kerstin Wilken, PDA Europe

    11:00 - 11:40
    WFI Using Membrane Technology - First Impressions after the Regulatory Change
    Fritz Roeder, Merck KGaA

    11:40 -12:10
    Membrane-based Ambient WFI for Biomanufacturing: Regulatory Background - Opportunities and Risks
    Jochen Schmidt-Nawrot, CRB Group

    12:10 -12:30
    Q&A, Discussion

    11:10 - 12:30
    Session 5C: Practical Approaches to Contamination Control
    Moderator: Walid El-Azab, STERIS

    11:10 - 11:40
    Contamination Control Strategy
    Cornelia Haas, VTU Engineering

    11:40 -12:10
    Are You Wearing Too Little or Too Much: Optimizing Gowning Controls for Reduced Bioburden Manufacturing
    Kavita Ramalingam Iyer, GSK

    12:10 -12:30
    Q&A, Discussion

    12:30 - 13:30
    Lunch Break, Poster Session & Exhibition

    Transition to Two Parallel Tracks

    13:30 - 14:40
    Session 6A: Single Use Systems
    Moderator: Elisabeth Vachette, Sartorius Stedim

    13:30 - 13:55
    Reduction of Risks from Particulate Matter in Single-Use Systems
    Klaus Wormuth, Sartorius Stedim

    13:55 - 14:20
    Development of a Scalable Adenovirus-Based Rabies Vaccine Based on Single Use Technologies
    Josselyn Haas, Merck KGaA

    14:20 - 14:40
    Q&A, Discussion

    13:30 - 14:40
    Session 6B: Comparability
    Moderator: Cristiana Campa, , GSK Vaccines

    13:30 - 13:55
    FDA's Totality of Evidence for Risk-Based Comparability Protocols Over Lifecycle and for Similarity Assessments
    Jose Menezes, 4TuneEngineering

    13:55 - 14:20
    Comparability Risk Assessment
    John O’Hara, UCB

    14:20 - 14:40
    Q&A, Discussion

    14:40 - 15:10
    Coffee Break, Poster Session & Exhibition

    15:10 - 16:30
    Closing Plenary: Panel Discussion

    15:10 - 16:15
    A Short Introduction to the EMA 2025 Regulatory Science Strategy
    Dolores Hernan, European Medicines Agency

    Panel Discussion with Regulatory and Industry Experts
    • Introduction to the EMA 2025 Regulatory Science Strategy
    • Post Approval Changes
    • Revision of ICH Q2(R1) and new ICH Q14 guidance
    • PUPSIT
    • Comparability
    • Accelerated Access
    • And More Hot Topics from the Conference

    Nanna Kruse, Danish Medicines Agency
    Mats Welin, Swedish Medical Products Agency
    Wilhelm Herok, Austrian Agency for Health and Food Safety
    Martijn van der Plan, Dutch Medicines Evaluation Board

    16:15 - 16:30
    Conference Summary & Conclusions
    Cristiana Campa, Chair, GSK Vaccines
    Michael De Felippis, Chair, Eli Lilly

    16:30
    Closing Remarks & End of Conference & Farewell
    Kerstin Wilken, PDA Europe

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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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.

Sheraton Munich Arabellapark Hotel

Arabellastrasse 5
Munich, Germany
Phone: +49 (0)89 92320

Sheraton Munich Arabellapark Hotel
  • Accommodations

    Hotel Website

    The elegant 4-star Sheraton Munich Arabellapark Hotel offers a soundproof accommodation in a residential area of Munich. Featuring chic architecture, the hotel was renovated in 2007. The property is located in Bogenhausen district, 3.5 km from Marienplatz. The city center lies within 4 km from the venue.

    A spectacular view over the countryside welcomes guests to club superior king suite, junior king suite and executive flat with modern-style décor. The property boasts views of Alps from its rooms. Room facilities also include a microwave, an electric kettle and coffee/tea makers for self-catering. The property is in a 5-minute walking distance from Richard-Strauss-Straße subway station. It will take 35 minutes to get to Franz Josef Strauss airport by car.

    PDA Europe has reserved a limited number of rooms until the 7th July 2019.
    Book Your Room for the PDA Group Rate.

    Single Room € 169 per night* 
    Double Room € 194 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
  • Amenities

How to Get Here

By Air

Nearest Airport: Munich Airport - MUC
Airport Phone: +49 89 975 00

By Car

21.7 mi (35 km), 29 min by car. Sheraton Munich Arabellapark Hotel is located at ArabellaStrasse 5, Munich 81925 Germany.

Other Options

Estimated taxi fare: 55 EUR (one way).

Bus service fee: 10.5 EUR (one way).

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Registration Type Price by 07 July
Member €1.495
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Registration Type Price after 07 July
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €850
Young Professional (Member) €850

All fees given in Euro and excluding VAT

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

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