PDA Europe Virtual Conference - BioManufacturing

Name: PDA Europe Virtual Conference - BioManufacturing
Start: 2020-09-22
End: 2020-09-23

Sep 22 - Sep 23, 2020

W. Europe Standard Time | Online

Virtual
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Program Highlights

The 2020 PDA Europe Virtual BioManufacturing Conference will focus on Driving Biopharmaceutical Innovation and Sustainability!

Don't miss the LIVE Q&As and Panel Discussions with distiguished experts from the industry and regulatory representatives from the Paul-Ehrlich-Institut, EMA, as well as the Swedish and Belgian Agencies!

Overview

Manufacturing science and technology continues to play an essential role in enabling biopharmaceutical innovation. While biopharmaceuticals comprise multiple molecular formats, there are important similarities connecting the different production platforms used for manufacturing. This connectivity provides ample opportunities to share key knowledge and learning across various product types and associated scientific disciplines. In line with its mission of connecting people, science and regulation, PDA Europe has recognized the need for a forum to communicate information and facilitate interaction in the field of biopharmaceutical manufacturing. Following a successful inaugural event in 2019, PDA Europe is proud to announce the second edition of BioManufacturing, this year presented as a Virtual Conference on 22-23 September 2020.

The 2020 conference will provide an exceptional opportunity to present the latest innovative approaches for biopharmaceutical manufacturing and discuss hot topics related to process, product, analytics and regulatory strategies with a broad audience, including representatives from companies, academic research institutions, regulatory agencies and Official Medicines Control Laboratories. A variety of biopharmaceutical product classes will be considered, including Therapeutic Proteins and Vaccines..

The program will be accompanied by interactive activities and virtual networking opportunites! A vendor exhibition featuring the latest manufacturing technologies and materials will also complement a strong agenda of knowlegdable experts on the online platform!

Sincerely,
The Chairs

Michael De Felippis, PhD
Eli Lilly and Company

Cristiana Campa, PhD
GSK Vaccines

Agenda

Day 1
Day 2

Tuesday, 22 September 2020

Module I: Welcome & Opening
12:00 - 12:30 CEST

Welcome & Introductions	Falk Klar, PDA Europe
Welcome from the Chairs	Cristiana Campa, GSK Vaccines, Chair Michael De Felippis, Eli Lilly & Company, Chair
Keynote: Industry 4.0 and Regulatory Advances to New Technologies	Maeve Lally, HPRA

Transition Break
12:30 - 12:35 CEST

Module II: Accelerating Biopharmaceutical Innovation
12:35 - 14:05 CEST

The global health crisis created by the COVID-19 pandemic has created opportunities for challenging conventional thinking on traditional approaches to biopharmaceutical development and manufacturing. Motivated by an urgent need to accelerate the availability of potential new medicines to combat the disease, industry is implementing novel approaches to streamline work and dramatically reduce timelines while simultaneously ensuring reliable manufacturing processes for producing high-quality product. Regulatory authorities are also playing an important role by establishing flexible frameworks to support rapid clinical investigation and sustainable supply of therapeutic products and vaccines. Finding ways to apply the learnings from this experience can help speed future biopharmaceutical innovation to patients and ensure better preparation for other potential public health emergencies. In this plenary session, regulatory authority thought leaders provide perspectives and important information on acceleration strategies.
Accelerating Biopharmaceutical Innovation	Moderators: Cristiana Campa, GSK Vaccines Michael De Felippis, Eli Lilly & Company
COVID-19 Biologics- Procedural Aspects and Quality Scientific Considerations in the Context of The Crisis – an EMA Perspective	Ragini Shivji, European Medicines Agency
How to Facilitate CMC Development in Pandemic Situations	Steffen Gross, Paul-Ehrlich-Institut
Specifications for Biologics and the Use of Prior Knowledge for Biotherapeutics and Vaccines – Manufacturing	Mats Welin, Medical Products Agency Sweden
Live Q & A, Discussion

Virtual Networking & Exhibition
14:20 - 15:15 CEST

Module III: Accelerating & Sustaining Access to Innovative Biologics & Vaccines
14:20 - 15:15 CEST

The recent Covid-19 outbreak has evidenced how essential, but also how challenging, a quick access to new biologics and vaccines can be in the context of an emerging threat. These innovative biologics and vaccines must not only demonstrate their efficacy and safety, but they also have to be made available to as many people as possible, quickly and for an affordable price. In this session, industry and regulators will share their experience with the development, review and approval of an Ebola vaccine in the context of the 2014-2016 outbreak in Liberia, Sierra Leone and Guinea, and of the 2018-2020 outbreak in The Democratic Republic of the Congo. Presentations will cover, but are not limited to, innovative approaches to accelerate technical and analytical development, validation and scale-up, as well as to expedite regulatory review, GMP inspections and approval of new manufacturing sites.
Accelerating & Sustaining Access to Innovative Biologics & Vaccines	Moderators: Florence Wauters, MSD Elisabeth Vachette, Sartorius Stedim
The EMA PRIME Procedure in an Accelerated Assessment Environment for Vaccine Licensure: Experiences from Quality (CMC) Assessors – a Case Study for an Ebola Vaccine	Wim Van Molle, Sciensano
Developing ERVEBO® to Address a Worldwide Health Concern	Kay Hunsberger, MSD
Live Q & A, Discussion

Virtual Networking & Exhibition
15:15 - 16:15 CEST

Module IV: Robotics & Lifecycle Management
16:15 - 17:45 CEST

TRACK A – ROBOTICS		TRACK B – LIFECYCLE MANAGEMENT
Moderators: Richard Denk, SKAN Lucia Ceresa, Charles River		Moderators: Jonny Parsons, Amgen Cristiana Campa, GSK Vaccines
In biomanufacturing robotics take over complex or monotone working procedures in some areas. Gloveless isolators with integrated robotic solutions are an additional trend in aseptic processing. During aseptic Fill & Finish robotics perform almost all activities without human intervention to improve product safety. Robotics are modern novel technologies to improve the product quality with validated and reproductible operation.		This session provides an overview on recent considerations for lifecycle management. What can we expect in the future from analytical methods and validation concepts? How can principles of quality risk management be applied to vaccine development and lifecycle? The pragmatic constraints and practical risk mitigation measures with consideration for current regulatory expectations and commercial manufacturing process robustness will be discussed.
Possibilities for Modern Robotics in Biopharma	Christine Eckardt, PM Group	Managing Charge Heterogeneity Through a Product's Lifecycle	Cillian McCabe, Eli Lilly & Company
Facility of the Future: an Aseptic Smart, Modular, Gloveless Robotic Filling Isolator Technology	Thomas Thurn & Dieter Bachmann, Janssen Pharmaceuticals - a J&J company	Comparability in Development and Lifecycle of Biological Products	Simona Cianetti, GSK
Robotics, Inspection and Automation Ensuring Quality & Compliance	John Walshe, Ward Automation	A Vision of The Future of Analytical Method Life Cycle Management: Towards Flexible Business Operations Allowed by Data-Driven Continuous Control	Jean-Francois Dierick, GSK Vaccines
Live Q & A, Discussion		Live Q & A, Discussion

Virtual Networking Event
17:45 - 18:45 CEST

Meet Your Peers in Our Networking Lounges
Lounge I	Meet the Regulators
Lounge II	Control Strategies to Respond to Pandemic Threats: Interest Group Vaccines
Lounge III	Technology and Knowledge Transfer: Status of the Technical Report 65
Lounge IV	Meet the Interest Groups BioManufacturing & Process Validation

Wednesday, 23 September 2020

Module V: Platform Technologies & Environmental Monitoring & Decontamination Strategies
10:00 - 11:00 CEST

TRACK A – PLATFORM TECHNOLOGIES		TRACK B – ENVIRONMENTAL MONITORING AND DECONTAMINATION STRATEGIES
Moderators: Sebastian Teitz, Asahi Kasei Mark van Ooij, Janssen Vaccines		Moderators: Lucia Ceresa, Charles River Walid El Azab, STERIS
Platform technologies are becoming a popular industry approach for bioprocessing and the approach potentially simplifies transactions & interactions between the stakeholders of biopharmaceuticals product development and manufacturing. This session explores the implications of Quality by Design (QbD) considerations as well as the utilization of new technologies and approaches towards vaccine manufacturing and development.		How to put into practice the Quality Risk Management Principles (QRM) in establishing a robust Environmental Monitoring program is always a timely, relevant and hot topic. The learning objective of this section is to review and address the last updated version 2020 of the PDA Technical Report 13 guidance on Environmental Monitoring. In addition to QRM, the TR will also include practical guidance on Rapid Microbiological Methods (RMM) and automated monitoring systems and more. Moreover, you will learn about the exciting and anticipated proposal for Surface Decontamination Transfer from Grade C or D to a Grade A based on e-beam decontamination and about the upcoming new Technical Paper by PDA on Isolator use.
Vaccine Platforms: the GMMA Case Study	Francesca Micoli, GSK	Update of the Technical Report TR13 on the Fundamentals of an Environmental Monitoring Program: What’s New?	Kurt Jaecques, GSK Vaccines Marc Glogovsky, Valsource
Quality by Design and Techno-Economic Modelling of RNA Vaccine Production	Zoltán Kis, Imperial College London	How to Decontaminate Ready to Use RTU "Nested Vials or Syringes” for the Use in Isolators	Manfred Holzer, SKAN Andreas Kerschbaumer, Novartis
Live Q & A, Discussion		Live Q & A, Discussion

Virtual Networking & Exhibition
11:30 - 11:50 CEST

Meet the Poster Presenter:
Moderator: Cristiana Campa, GSK Vaccines
Poster Presenters are invited to present their content in a brief Elevator Pitch in a separate Live Room

Module VI: Process Development & Modelling & Cross-Contamination Control for Highly Potent APIs
11:50 -13:00 CEST

TRACK A – PROCESS DEVELOPMENT AND MODELLING		TRACK B – CROSS-CONTAMINATION CONTROL FOR HIGHLY POTENT APIS
Moderators: Mark van Ooij, Janssen Vaccines Jonny Parsons, Amgen		Moderators: Walid El-Azab, STERIS Susanne Jörg, LONZA
Companies are looking into more and more to compress product development timelines amongst other due to cost involved and competitive landscape. One of the ways to potentially expedite product development is by using modelling approaches. A plethora of modelling approaches are currently available which are used at various stage and to address different aspects in product development.		Cross-contamination control is an essential element of the Contamination Control Strategy (CCS). The CCS is a culmination of an exercise to identify activities designed to prevent microorganisms, pyrogens, and particulates contamination in the product and supporting process used to manufacture the product. During this session, two presentations share their perspective on how to prevent cross-contamination by exploring the modern concept of the cleaning and occupational limit while mixing engineering best design practices and increase regulatory expectations for aseptic processing.
Model-guided Drug Substance Process Development	Rui Portela, GSK Vaccines	Aseptic Processing: GMP and Occupational Safety Requirements for Highly Potent Substances	Richard Denk, SKAN Reinhold Maeck, Boehringer Ingelheim
Impact Quantification of Upstream Process Conditions on End-to-End Bioprocess Performance: A Case Study on Monoclonal Antibodies	Maria Papathanasiou, Imperial College London	Aseptic Meets High-Potent: Setting the Stage for Next Level ADC Processing	Matthias Angelmeier, Syntegon Technologies
Live Q & A, Discussion		Live Q & A, Discussion

Break & Virtual Exhibition
13:00 - 13:30 CEST

Module VII: Drug Product Development & Formulation & Container Closure Integrity
13:30 - 14:45 CEST

TRACK A – DRUG PRODUCT DEVELOPMENT AND FORMULATION		TRACK B – CONTAINER CLOSURE INTEGRITY
Moderators: Susanne Jörg, LONZA Florence Wauters, MSD		Moderators: Elisabeth Vachette, Sartorius Stedim Sebastian Teitz, Asahi Kasei
This session focuses on the integrated development and manufacturing approach of Biologics Drug Products, typical challenges and case studies how to rationally approach these. One presentation will cover innovation strategies for continuous improvement utilizing tools such as data analysis and machine learning. Biologics molecules can be quite sensitive with regard to various potential stresses, including temperature, light, mechanical stresses due to shaking or shear, stresses during freezing and thawing but also with regard to potential sensitivity to process residuals, such as extractables and leachables. Another presentation will focus on the potential interaction of excipients like surfactants with the manufacturing process should be watched-out and investigated.		Container closure integrity requirements are in constant evolution. This session will focus on latest scientific and regulatory advancements for Single-Use Systems Integrity (SUSI) and how Container closure integrity is ensured for novel & advanced therapies
Modernizing Drug Product Development and Manufacturing through Innovation and Application of Data Science and Machine Learning	Nitin Rathore, Amgen	Consistent Robustness and Integrity Testing Lead to Enhanced Process Integrity and Patient Safety	Marc Hogreve, Sartorius Stedim
Polysorbate in Biologics – Understanding Degradation by Application of Proper Analytics	Michael Jahn, Lonza Drug Product Services	Dynamic Challenge of Container Sealing Performance for Biologics and Cell & Gene Therapy at Cold Temperature	Qingyu Zeng, WEST
Live Q & A, Discussion		Live Q & A, Discussion

Virtual Networking & Exhibition
14:45 - 16:00 CEST

Module VIII: Closing Plenary: Sustainability and Future Directions in Biopharmaceutical Manufacturing
16:00 - 18:15 CEST

The manufacture of biopharmaceutical products inherently consumes large quantities of natural, human and economic resources. Responding to the global focus on achieving a sustainable future, industry is taking steps to ensure it will have a positive impact on the environment. Improving efficiency of manufacturing operations, lowering energy usage, conserving raw materials, recovering and repurposing solvents, and reducing overall waste are areas of primary attention. In addition, to protecting the planet, industry is modernizing its operations by implementing technologies, such as, artificial Intelligence, machine learning, internet-of-things, blockchain, predictive analytics, Industry 4.0 and digital twins. This session explores examples of industry’s sustainability efforts and future directions with digital transformation, soliciting reflection on applicability for both new and established products, and engaging discussion with attending Regulators.
Closing Plenary: Sustainability and Future Directions in Biopharmaceutical Manufacturing	Moderators: Cristiana Campa, GSK Vaccines Michael De Felippis, Eli Lilly
How can the New Plastic Economy Influence Pharma and Bioprocesses?	Magali Barbaroux, Sartorius Stedim
Single-use Biomanufacturing Waste Management & Recycling	Chor Sing Tan, Cytiva

Virtual Networking & Exhibition

A Paradigm Shift in Process Monitoring within a Digital Transformation Program	Anthony Maguire, Eli Lilly & Company
Lessons Learned from Implementation of a Data Analytics Solution to Support Biomanufacturing Operations	Gerald Kierans, Pfizer
LIVE Session: Panel Discussion on Innovations & Sustainability in Pharma with Regulatory and Industry Representatives How have innovations in product development, biomanufacturing and regulatory strategy aided the current COVID-19 emergency situation? Will it be possible to apply these innovations to accelerate biopharmaceuticals to patients in non-emergency situations? What is the priority of manufacturing sustainability strategies (e.g., waste management, recycling policies) in the current health emergency? What future innovations will further drive sustainability strategies in biopharmaceutical manufacturing?
Conference Summaries by the Chairs	Cristiana Campa, GSK Vaccines, Chair Michael De Felippis, Eli Lilly & Company, Chair
Closing Remarks & Farewell	Falk Klar, PDA Europe

Registration Fees

Registration Type	Registration Fee
Member, Non-Member, Young Professional, Poster-Presenter	€ 1.395
Govern./Health Authority/Academic	€ 645

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