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Welcome and Introduction and Keynotes
01:00pm - 06:00pm Central European Time - September 22, 2021
Thomas B. Hartman, President and CEO, ISPE; Antonio R. Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland, Baltimore County; Wilson W. Bryan, M.D., Director, Office of Tissues and Advanced Therapies, CBER/FDA; Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences; Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG; Matthew JH Davis, Senior GMP Inspector, Therapeutic Goods Administration; Rino Rappuoli, Chief Scientist and Head External R&D, GSK Vaccines; Jessica Beyer, Director, Cell Therapy Manufacturing, Bristol Myers Squibb; Carolyn Laurencot, Associate Director for Regulatory Science and Review, Division of Cellular & G, FDA (US Food and Drug Administration); Oliver Hennig, Dr., Senior Vice President Operations, BioNTech SE; Sandy Douglas, Academic Clinician, University of Oxford

Wednesday
Welcome and Introduction
01:00pm - 01:10pm Central European Time - September 22, 2021
Thomas B. Hartman, President and CEO, ISPE
Welcome and Introduction |
Wednesday
ISPE Foundation
01:10pm - 01:15pm Central European Time - September 22, 2021
Antonio R. Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland, Baltimore County
ISPE Foundation |
Wednesday
Development of Cell and Gene Therapies During COVID-19 Pandemic
01:15pm - 01:45pm Central European Time - September 22, 2021
Wilson W. Bryan, M.D., Director, Office of Tissues and Advanced Therapies, CBER/FDA
Development of Cell and Gene Therapies During COVID-19 Pandemic |
Wednesday
Regulatory Aspects for ATMPs, based on PIC/S Annex 2 2A and EU GMP Annex 1
01:45pm - 02:15pm Central European Time - September 22, 2021
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG; Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences; Matthew JH Davis, Senior GMP Inspector, Therapeutic Goods Administration
Regulatory Aspects for ATMPs, based on PIC/S Annex 2 2A and EU GMP Annex 1|
Wednesday
Vaccines and Monoclonal Antibodies to Regain Our Freedom
02:15pm - 02:45pm Central European Time - September 22, 2021
Rino Rappuoli, Chief Scientist and Head External R&D, GSK Vaccines
Vaccines and Monoclonal Antibodies to Regain Our Freedom |
Wednesday
Implementation of Electronic Batch Records in Cell Therapy: Positives and Challenges
02:45pm - 03:15pm Central European Time - September 22, 2021
Jessica Beyer, Director, Cell Therapy Manufacturing, Bristol Myers Squibb
Implementation of Electronic Batch Records in Cell Therapy: Positives and Challenges|
Wednesday
Networking Break in the ISPE Networking Lounge
03:15pm - 03:45pm Central European Time - September 22, 2021
Jessica Beyer, Director, Cell Therapy Manufacturing, Bristol Myers Squibb
Networking Break in the ISPE Networking Lounge |
Wednesday
Cellular and Gene Therapy Products: A CMC Regulatory Perspective
03:45pm - 04:15pm Central European Time - September 22, 2021
Carolyn Laurencot, Associate Director for Regulatory Science and Review, Division of Cellular & G, FDA (US Food and Drug Administration)
Cellular and Gene Therapy Products: A CMC Regulatory Perspective |
Wednesday
BioNTech’s Road to One Billion Doses of mRNA Vaccines
04:15pm - 04:45pm Central European Time - September 22, 2021
Oliver Hennig, Dr., Senior Vice President Operations, BioNTech SE
BioNTech’s Road to One Billion Doses of mRNA Vaccines|
Wednesday
Manufacturing an Adenovirus-Vectored Covid-19 Vaccine: From Bench to Millions of Doses in Months
04:45pm - 05:15pm Central European Time - September 22, 2021
Sandy Douglas, Academic Clinician, University of Oxford
Manufacturing an Adenovirus-Vectored Covid-19 Vaccine: From Bench to Millions of Doses in Months|
Wednesday
Panel Discussion with the Keynote Speakers and Closing Remarks
05:15pm - 06:00pm Central European Time - September 22, 2021
Wilson W. Bryan, M.D., Director, Office of Tissues and Advanced Therapies, CBER/FDA; Oliver Hennig, Dr., Senior Vice President Operations, BioNTech SE; Sandy Douglas, Academic Clinician, University of Oxford; Rino Rappuoli, Chief Scientist and Head External R&D, GSK Vaccines; Carolyn Laurencot, Associate Director for Regulatory Science and Review, Division of Cellular & G, FDA (US Food and Drug Administration); Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG; Matthew JH Davis, Senior GMP Inspector, Therapeutic Goods Administration; Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences; Jessica Beyer, Director, Cell Therapy Manufacturing, Bristol Myers Squibb
Panel Discussion with the Keynote Speakers and Closing Remarks|
Wednesday
Workshop 1: Control Strategy, Technology Transfer, CMC, Computer-based Modeling (EL Article)
06:00pm - 07:30pm Central European Time - September 22, 2021
Thomas Zahel, PhD, Head of Innovation, Körber Pharma, Werum IT Solutions GmbH; Christoph Herwig, PhD, Professor, Vienna University of Technology
Track: Workshops
Workshop 1: Control Strategy, Technology Transfer, CMC, Computer-based Modeling (EL Article)|
Track 1: Pharma 4.0™ in Biotechnology Accelerated by Digitalisation
01:00pm - 04:00pm Central European Time - September 23, 2021
Thomas Zahel, PhD, Head of Innovation, Körber Pharma, Werum IT Solutions GmbH; Robert W. Landertinger Forero, Head of QA in Drug Product, Sanofi-Aventis Pharma Deutschland GmbH; Marco Kunzelmann, Senior Statistician, Boehringer Ingelheim Pharma GmbH & Co. KG; Marick Paris-Cadet, Pharmaceutical Project Engineer, Technip Energies; Francisca Folque Gouveia, MS&T Senior Process Expert, Novartis Pharma S.A.S. Manufacturing Science and Technology (MS&T); Amy Hardwick, Technical Regulatory Program Associate Director, INeST, Genentech; Robin Schiemer, PhD Candidate, Karlsruhe Institute of Technology; Julia Walther, MS&T Engineer, VTU Engineering Deutschland GmbH

Thursday
Validation 4.0 - Applied FDA Good Machine Learning Practices - Case Studies
01:00pm - 01:20pm Central European Time - September 23, 2021
Thomas Zahel, PhD, Head of Innovation, Körber Pharma, Werum IT Solutions GmbH; Robert W. Landertinger Forero, Head of QA in Drug Product, Sanofi-Aventis Pharma Deutschland GmbH
Validation 4.0 - Applied FDA Good Machine Learning Practices - Case Studies |
Thursday
Specification Driven Acceptance Criteria Based on a Holistic IPM
01:20pm - 01:40pm Central European Time - September 23, 2021
Marco Kunzelmann, Senior Statistician, Boehringer Ingelheim Pharma GmbH & Co. KG
Specification Driven Acceptance Criteria Based on a Holistic IPM|
Thursday
Digitalisation for Construction Management of Large Biopharmaceutical Plants - Case Study
01:40pm - 02:00pm Central European Time - September 23, 2021
Marick Paris-Cadet, Pharmaceutical Project Engineer, Technip Energies
Digitalisation for Construction Management of Large Biopharmaceutical Plants - Case Study|
Thursday
Digital Transformation in Biomanufacturing: A Risk and Compliance Perspective
02:00pm - 02:20pm Central European Time - September 23, 2021
Francisca Folque Gouveia, MS&T Senior Process Expert, Novartis Pharma S.A.S. Manufacturing Science and Technology (MS&T)
Digital Transformation in Biomanufacturing: A Risk and Compliance Perspective|
Thursday
Networking Break in the ISPE Networking Lounge
02:20pm - 03:00pm Central European Time - September 23, 2021
Amy Hardwick, Technical Regulatory Program Associate Director, INeST, Genentech
Networking Break in the ISPE Networking Lounge |
Thursday
Machine Learning-Assisted Downstream Process Development - Case Studies
03:00pm - 03:15pm Central European Time - September 23, 2021
Robin Schiemer, PhD Candidate, Karlsruhe Institute of Technology
Machine Learning-Assisted Downstream Process Development - Case Studies |
Thursday
Gene Expression Dynamics Under Simulated Fluctuating Substrate Conditions Derived from a Scale-Down Reactor
03:15pm - 03:30pm Central European Time - September 23, 2021
Julia Walther, MS&T Engineer, VTU Engineering Deutschland GmbH
Gene Expression Dynamics Under Simulated Fluctuating Substrate Conditions Derived from a Scale-Down Reactor|
Thursday
Panel Discussion with Speakers in "Track 1: Pharma 4.0™ in Biotechnology Accelerated by Digitalisation" and Closing Remarks
03:30pm - 04:00pm Central European Time - September 23, 2021
Thomas Zahel, PhD, Head of Innovation, Körber Pharma, Werum IT Solutions GmbH; Francisca Folque Gouveia, MS&T Senior Process Expert, Novartis Pharma S.A.S. Manufacturing Science and Technology (MS&T); Robin Schiemer, PhD Candidate, Karlsruhe Institute of Technology; Marco Kunzelmann, Senior Statistician, Boehringer Ingelheim Pharma GmbH & Co. KG; Julia Walther, MS&T Engineer, VTU Engineering Deutschland GmbH; Robert W. Landertinger Forero, Head of QA in Drug Product, Sanofi-Aventis Pharma Deutschland GmbH; Marick Paris-Cadet, Pharmaceutical Project Engineer, Technip Energies
Panel Discussion with Speakers in "Track 1: Pharma 4.0™ in Biotechnology Accelerated by Digitalisation" and Closing Remarks|
Thursday
Networking Break in the ISPE Networking Lounge
04:00pm - 04:30pm Central European Time - September 23, 2021
Marick Paris-Cadet, Pharmaceutical Project Engineer, Technip Energies
Networking Break in the ISPE Networking Lounge|
Track 2: Operations Readiness, Technology Transfer and Risk based Case Studies
01:00pm - 04:00pm Central European Time - September 23, 2021
Mark Grothkopp, Research Associate & PhD Candidate, University of St. Gallen (Switzerland); Thomas Friedli, PhD, Professor of Production Management, Director ITEM, Division Production Managemen, University of St. Gallen (Switzerland); Kimberly-Anne Mattia, Process Technology Scientific Leader, GSK; Fiona Madden, Senior Scientist / Manager, Janssen Biologics (Ireland); Charlie Maher, BS, MBA, Senior Director, Capital Projects, Validation and Operational Readiness, Resilience

Thursday
Operational Excellence in the Pharmaceutical Industry - From Innocence to World Leading
01:00pm - 01:20pm Central European Time - September 23, 2021
Mark Grothkopp, Research Associate & PhD Candidate, University of St. Gallen (Switzerland); Thomas Friedli, PhD, Professor of Production Management, Director ITEM, Division Production Managemen, University of St. Gallen (Switzerland)
Operational Excellence in the Pharmaceutical Industry - From Innocence to World Leading |
Thursday
Retrofitting an Existing Bioprocessing Facility for Vector Manufacturing: A Case Study in Managing Major Manufacturing Process Changes Mid-Project |
Thursday
Operation Readiness
02:00pm - 02:20pm Central European Time - September 23, 2021
Fiona Madden, Senior Scientist / Manager, Janssen Biologics (Ireland)
Operation Readiness|
Thursday
Networking Break in the ISPE Networking Lounge
02:20pm - 03:00pm Central European Time - September 23, 2021
Thursday
Designing for Operation Readiness
03:00pm - 03:20pm Central European Time - September 23, 2021
Charlie Maher, BS, MBA, Senior Director, Capital Projects, Validation and Operational Readiness, Resilience
Designing for Operation Readiness |
Thursday
Panel Discussion with Speakers in "Track 2: Operations Readiness, Technology Transfer and Risk based Case Studies" and Closing Remarks
03:20pm - 04:00pm Central European Time - September 23, 2021
Charlie Maher, BS, MBA, Senior Director, Capital Projects, Validation and Operational Readiness, Resilience; Fiona Madden, Senior Scientist / Manager, Janssen Biologics (Ireland); Mark Grothkopp, Research Associate & PhD Candidate, University of St. Gallen (Switzerland); Kimberly-Anne Mattia, Process Technology Scientific Leader, GSK; Thomas Friedli, PhD, Professor of Production Management, Director ITEM, Division Production Managemen, University of St. Gallen (Switzerland)
Panel Discussion with Speakers in "Track 2: Operations Readiness, Technology Transfer and Risk based Case Studies" and Closing Remarks|
Thursday
Networking Break in the ISPE Networking Lounge
04:00pm - 04:30pm Central European Time - September 23, 2021
Track 3: Cell and Gene Therapy Products, ATMPs, Projects, Commercial Manufacturing
01:00pm - 04:00pm Central European Time - September 23, 2021
Alessandro Linciano, Project Director, Stein Cell & Gene Therapy, Novartis Technical Operation; Angel Alvarez-Mangual, Senior Manager, Process Sciences, Cellectis; Leslie M. Edwards, MSE, Vice President, Technology & Business Development, Skan US; Jennifer Cheung, Vice President Quality Assurance and Regulatory Affairs, WuXi Advanced Therapies; Amy Hardwick, Technical Regulatory Program Associate Director, INeST, Genentech; J. Andrew Case, Head of Clinical Supply Chain - Individualized Therapies, Genentech

Thursday
CAR-T Manufacturing, a Fast Evolution Through Challenges and Opportunities
01:00pm - 01:20pm Central European Time - September 23, 2021
Alessandro Linciano, Project Director, Stein Cell & Gene Therapy, Novartis Technical Operation
CAR-T Manufacturing, a Fast Evolution Through Challenges and Opportunities |
Thursday
Modular and Flexible Manufacturing for Cell and Gene Therapies
01:20pm - 01:40pm Central European Time - September 23, 2021
Angel Alvarez-Mangual, Senior Manager, Process Sciences, Cellectis; Leslie M. Edwards, MSE, Vice President, Technology & Business Development, Skan US
Modular and Flexible Manufacturing for Cell and Gene Therapies|
Thursday
Quality and Regulatory Challenges Surrounding Cell and Gene Therapy Products
01:40pm - 02:00pm Central European Time - September 23, 2021
Jennifer Cheung, Vice President Quality Assurance and Regulatory Affairs, WuXi Advanced Therapies
Quality and Regulatory Challenges Surrounding Cell and Gene Therapy Products |
Thursday
Individualised Neo-Antigen-Specific Therapies: Unique CMC Challenges and a Novel Regulatory Framework
02:00pm - 02:20pm Central European Time - September 23, 2021
Amy Hardwick, Technical Regulatory Program Associate Director, INeST, Genentech
Individualised Neo-Antigen-Specific Therapies: Unique CMC Challenges and a Novel Regulatory Framework|
Thursday
Networking Break in the ISPE Networking Lounge
02:20pm - 03:00pm Central European Time - September 23, 2021
Thursday
Establishing Supply Chain Capabilities for Individualised Therapies
03:00pm - 03:20pm Central European Time - September 23, 2021
J. Andrew Case, Head of Clinical Supply Chain - Individualized Therapies, Genentech
Establishing Supply Chain Capabilities for Individualised Therapies|
Thursday
Panel Discussion with Speakers in "Track 3: Cell and Gene Therapy Products, ATMPs, Projects, Commercial Manufacturing" and Closing Remarks
03:20pm - 04:00pm Central European Time - September 23, 2021
Jennifer Cheung, Vice President Quality Assurance and Regulatory Affairs, WuXi Advanced Therapies; Leslie M. Edwards, MSE, Vice President, Technology & Business Development, Skan US; Alessandro Linciano, Project Director, Stein Cell & Gene Therapy, Novartis Technical Operation; Amy Hardwick, Technical Regulatory Program Associate Director, INeST, Genentech; J. Andrew Case, Head of Clinical Supply Chain - Individualized Therapies, Genentech; Angel Alvarez-Mangual, Senior Manager, Process Sciences, Cellectis
Panel Discussion with Speakers in "Track 3: Cell and Gene Therapy Products, ATMPs, Projects, Commercial Manufacturing" and Closing Remarks|
Thursday
Networking Break in the ISPE Networking Lounge
04:00pm - 04:30pm Central European Time - September 23, 2021
Thursday
Workshop 2: Work-stream - ATMPs, Facility Design, GXP Compliance
04:30pm - 06:00pm Central European Time - September 23, 2021
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG; Jean-Francois Duliere, Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate; Prudence Edwards, Double Degree Engineering Student (University of Queensland/Centrale Marseille)
Track: Workshops
Workshop 2: Work-stream - ATMPs, Facility Design, GXP Compliance|
Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development
01:00pm - 04:15pm Central European Time - September 24, 2021
Daniel P. DeCollibus, Sr. Scientist, Process Development, Amgen; René Thürmer, Quality Assessor, BfArm; Giuseppina Sandri, Associate Professor, University of Pavia; Olav Lyngberg, Sr. Scientific Fellow, Advanced Technology, Technical Operations, Janssen; Volker Huppert, Chief Development Officer, Glycostem Therapeutics; Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA); Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences; Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG

Friday
Terminal Sterilisation of Oligonucleotides: Insights and Recommendations
01:00pm - 01:20pm Central European Time - September 24, 2021
Daniel P. DeCollibus, Sr. Scientist, Process Development, Amgen
Terminal Sterilisation of Oligonucleotides: Insights and Recommendations |
Friday
Current Regulatory Trends for Synthetic Oligonucleotides
01:20pm - 01:40pm Central European Time - September 24, 2021
René Thürmer, Quality Assessor, BfArm
Current Regulatory Trends for Synthetic Oligonucleotides|
Friday
Electrospun Scaffolds for Dermal Tissue Engineering
02:00pm - 02:20pm Central European Time - September 24, 2021
Giuseppina Sandri, Associate Professor, University of Pavia
Electrospun Scaffolds for Dermal Tissue Engineering |
Friday
Networking Break in the ISPE Networking Lounge
02:20pm - 03:00pm Central European Time - September 24, 2021
Olav Lyngberg, Sr. Scientific Fellow, Advanced Technology, Technical Operations, Janssen
Networking Break in the ISPE Networking Lounge|
Friday
Cell Therapies Going Off-the-Shelf: The Beauty of Cord Blood Stem Cell-Derived Natural Killer Cells
03:00pm - 03:20pm Central European Time - September 24, 2021
Volker Huppert, Chief Development Officer, Glycostem Therapeutics
Cell Therapies Going Off-the-Shelf: The Beauty of Cord Blood Stem Cell-Derived Natural Killer Cells |
Friday
Update PIC/S Annex 2A for ATMPs Revision and PIC/S on Cell and Tissues
03:25pm - 03:50pm Central European Time - September 24, 2021
Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA); Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences; Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
Update PIC/S Annex 2A for ATMPs Revision and PIC/S on Cell and Tissues |
Friday
Panel Discussion with Speakers in "Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development" and Closing Remarks
03:50pm - 04:15pm Central European Time - September 24, 2021
Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences; Volker Huppert, Chief Development Officer, Glycostem Therapeutics; René Thürmer, Quality Assessor, BfArm; Daniel P. DeCollibus, Sr. Scientist, Process Development, Amgen; Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG; Giuseppina Sandri, Associate Professor, University of Pavia; Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
Panel Discussion with Speakers in "Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development" and Closing Remarks|
Track 5: COVID-19 Vaccines: Development, Manufacturing, Distribution, Vaccination, Impact, Current Situation
01:00pm - 04:15pm Central European Time - September 24, 2021
Ulrich Blaschke, Vice President Technical Development, BioNTech SE; Luke Kimmel, Global Director, Engineering Biotech, Pfizer; Joerg Heinrich, Head Operations Separations Technologies, Sartorius Stedim Biotech; John O'Hara, North American Supply Chain Lead for COVID-19, Janssen; Paul Granadillo, Senior Vice President Global Supply Chain, Moderna

Friday
Project Lightspeed: Development and Manufacturing of Comirnaty®, an mRNA-based vaccine against COVID-19
01:00pm - 01:25pm Central European Time - September 24, 2021
Ulrich Blaschke, Vice President Technical Development, BioNTech SE
Project Lightspeed: Development and Manufacturing of Comirnaty®, an mRNA-based vaccine against COVID-19|
Friday
Making the Impossible Possible
01:25pm - 01:50pm Central European Time - September 24, 2021
Luke Kimmel, Global Director, Engineering Biotech, Pfizer
Making the Impossible Possible |
Friday
Immediate Supply to COVID-19 Vaccines Manufacturers
01:50pm - 02:15pm Central European Time - September 24, 2021
Joerg Heinrich, Head Operations Separations Technologies, Sartorius Stedim Biotech
Immediate Supply to COVID-19 Vaccines Manufacturers |
Friday
Networking Break in the ISPE Networking Lounge
02:20pm - 03:00pm Central European Time - September 24, 2021
Friday
Supply Chain for COVID-19 Vaccines
03:00pm - 03:25pm Central European Time - September 24, 2021
John O'Hara, North American Supply Chain Lead for COVID-19, Janssen
Supply Chain for COVID-19 Vaccines |
Friday
Accelarating the Moderna COVID-19 Vaccine to Commercial Supply
03:25pm - 03:50pm Central European Time - September 24, 2021
Paul Granadillo, Senior Vice President Global Supply Chain, Moderna
Accelarating the Moderna COVID-19 Vaccine to Commercial Supply |
Friday
Panel Discussion with Speakers in "Track 5: COVID-19 Vaccines: Development, Manufacturing, Distribution, Vaccination, Impact, Current Situation" and Closing Remarks
03:50pm - 04:15pm Central European Time - September 24, 2021
Luke Kimmel, Global Director, Engineering Biotech, Pfizer; Ulrich Blaschke, Vice President Technical Development, BioNTech SE; Joerg Heinrich, Head Operations Separations Technologies, Sartorius Stedim Biotech; Paul Granadillo, Senior Vice President Global Supply Chain, Moderna; John O'Hara, North American Supply Chain Lead for COVID-19, Janssen
Panel Discussion with Speakers in "Track 5: COVID-19 Vaccines: Development, Manufacturing, Distribution, Vaccination, Impact, Current Situation" and Closing Remarks|
Track 6: mABs: Continuous BioManufacturing, Technology Enablers & Rationalisation
01:00pm - 04:15pm Central European Time - September 24, 2021
Jens Tränkle, Head PAT Biotechnology, Bayer AG; Cristiana Boi, Associate Professor, Department of Civil, Chemical, Environmental & Materials, University of Bologna; Barry J. McCarthy, Senior Director API Development, Janssen R&D; Olav Lyngberg, Sr. Scientific Fellow, Advanced Technology, Technical Operations, Janssen; Jean-Marc Bielser, Associate Director - Head of BPS Process Technologies, Merck; Ulrich Herber, Senior Director of Technology & Market Development, Charles River MS Germany GmbH; Jeffrey Carter, PhD, Consumables Product Strategy Leader, Cytiva

Friday
Advancing PAT & Automation for Advanced Therapeutic Modalities
01:00pm - 01:20pm Central European Time - September 24, 2021
Jens Tränkle, Head PAT Biotechnology, Bayer AG
Advancing PAT & Automation for Advanced Therapeutic Modalities|
Friday
Downstream Continuous BioManufacturing: Membrane Chromatography in mAbs Manufacturing
01:20pm - 01:40pm Central European Time - September 24, 2021
Cristiana Boi, Associate Professor, Department of Civil, Chemical, Environmental & Materials, University of Bologna
Downstream Continuous BioManufacturing: Membrane Chromatography in mAbs Manufacturing |
Friday
Large Molecule Drug Substance Process Intensification at Janssen Pharmaceuticals
01:40pm - 02:00pm Central European Time - September 24, 2021
Barry J. McCarthy, Senior Director API Development, Janssen R&D
Large Molecule Drug Substance Process Intensification at Janssen Pharmaceuticals|
Friday
Concept of Real Time Quality & Release Advanced Analytics for CM
02:00pm - 02:20pm Central European Time - September 24, 2021
Olav Lyngberg, Sr. Scientific Fellow, Advanced Technology, Technical Operations, Janssen
Concept of Real Time Quality & Release Advanced Analytics for CM|
Friday
Networking Break in the ISPE Networking Lounge
02:20pm - 03:00pm Central European Time - September 24, 2021
Friday
From Vision to Implementation: Strategies and Innovations that Enable the Transition to a Compact and Continuous Manufacturing Process for Therapeutic Proteins
03:00pm - 03:20pm Central European Time - September 24, 2021
Jean-Marc Bielser, Associate Director - Head of BPS Process Technologies, Merck
From Vision to Implementation: Strategies and Innovations that Enable the Transition to a Compact and Continuous Manufacturing Process for Therapeutic Proteins|
Friday
Harmonizing Rapid Contamination Detection Across the Biomanufacturing Process Through ATP Bioluminescence
03:20pm - 03:40pm Central European Time - September 24, 2021
Ulrich Herber, Senior Director of Technology & Market Development, Charles River MS Germany GmbH
Harmonizing Rapid Contamination Detection Across the Biomanufacturing Process Through ATP Bioluminescence |
Friday
ASTM International Consensus Standards: Facilitating Productivity in Bioprocessing
03:40pm - 04:00pm Central European Time - September 24, 2021
Jeffrey Carter, PhD, Consumables Product Strategy Leader, Cytiva
ASTM International Consensus Standards: Facilitating Productivity in Bioprocessing|
Friday
Panel Discussion with Speakers in "Track 6: mABs: Continuous BioManufacturing, Technology Enablers & Rationalisation" and Closing Remarks
04:00pm - 04:15pm Central European Time - September 24, 2021
Jeffrey Carter, PhD, Consumables Product Strategy Leader, Cytiva; Ulrich Herber, Senior Director of Technology & Market Development, Charles River MS Germany GmbH; Cristiana Boi, Associate Professor, Department of Civil, Chemical, Environmental & Materials, University of Bologna; Jean-Marc Bielser, Associate Director - Head of BPS Process Technologies, Merck; Olav Lyngberg, Sr. Scientific Fellow, Advanced Technology, Technical Operations, Janssen; Barry J. McCarthy, Senior Director API Development, Janssen R&D; Jens Tränkle, Head PAT Biotechnology, Bayer AG
Panel Discussion with Speakers in "Track 6: mABs: Continuous BioManufacturing, Technology Enablers & Rationalisation" and Closing Remarks|
Friday
Panel Discussion with Regulators and Closing Remarks
04:20pm - 05:00pm Central European Time - September 24, 2021
Wilson W. Bryan, M.D., Director, Office of Tissues and Advanced Therapies, CBER/FDA; Matthew JH Davis, Senior GMP Inspector, Therapeutic Goods Administration; Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA); René Thürmer, Quality Assessor, BfArm; Thomas B. Hartman, President and CEO, ISPE