2020 ispe continuous manufacturing virtual workshop

2020 ISPE

Continuous ManufacturingVirtual WorkshopA New Decade for Continuous Manufacturing: Current Landscape and Future Opportunities

3–4 June

Connect with us #ISPECM20 ISPE.org/CM20 | 2

2020 ISPEContinuous ManufacturingVirtual Workshop

Program AgendaWednesday 3 June 2020Wednesday 1000–1130

Opening Plenary—A New Decade for Continuous Manufacturing Session Leader: Sharmista Chatterjee, PhD, Division Director, Office of Pharmaceutical Manufacturing Assessment, CDER, FDA

Session Description: Continuous manufacturing for pharmaceutical and biopharmaceutical manufacturing is still in its infancy with only a limited number of products approved within the past 5 years. As we begin the third decade of the third millennium, we anticipate that bio/pharmaceutical manufacturing will continue to get smaller, faster, and smarter. In this opening conference session, a broad array of speakers from industry, academia, and regulatory agencies will provide their views on the state of continuous bio/pharmaceutical manufacturing today and predictions for its future.

1000–1010 Welcome and Opening Remarks Christine M. V. Moore, PhD, Conference Chair; Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.

1010–1015 LIVE Speaker IntroductionsSharmista Chatterjee, PhD, Division Director, Office of Pharmaceutical Manufacturing Assessment, CDER, FDA

1015–1035 ICH Q13 Guidance—Continuous Manufacturing of Drug Substance and Drug ProductRapti Madurawe, PhD, Director, Division of Process Assessment I, Office of Process and Facilities, CDER, FDA

1035–1055 End to End Collaboration to Transform Biopharmaceutical Development and ManufacturingJohn Erickson, PhD, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

1055–1115 Perspectives on the Implementation of Continuous ManufacturingSarah O’Keefe, PhD, Vice President, Small Molecule Design and Development, Eli Lilly and Company

1115–1130 Question and Answer/Discussion

1130–1200 Break



Program AgendaWednesday 3 June 2020 continuedWednesday 1200–1330 Concurrent Sessions

Continuous Manufacturing for Large Molecule— Drug Substance

Continuous Manufacturing for Small Molecule— Drug Product and API

Current Status on CM for Biologics: Development to Clinical Session Leader: Antonio Moreira, PhD, Vice Provost, University of Maryland, Baltimore County

Success Stories from Small Molecule Drug Product Session Leader: Wyatt Roth, PhD, Director, Small Molecule Design and Development, Eli Lilly and Company

Session Description: Speakers will provide insights on the current stage of deployment of CM for biological molecule clinical manufacturing from the point of view of process technologies, facility assets, and manufacturing operations. Examples of successes as well as challenges encountered will be shared.

Session Description: Significant progress in CM implementation has been made over the last ten years. From fundamental studies within academia to global drug product CM approvals, CM represents a paradigm shift within the industry that will continue to grow with time. In this session, success stories from some of the early adopters and implementers will be shared which include regulatory, technical, and business-related achievements in the hope that it will encourage others to join the CM movement!

1200–1210Speaker IntroductionsAntonio Moreira, PhD, Vice Provost, University of Maryland, Baltimore County

1210–1230The Biopharmaceutical Industry Emerging Continuous and Integrated Platform for Recombinant Protein Jon Coffman, PhD, Senior Director of Bioprocess Technology and Engineering, AstraZeneca

1230–1250Perspectives on the Development of Continuous Manufacturing for Biological Products Mark Brower, Principal Scientist, Merck & Co., Inc.

1250–1310Novel Technologies to Enable Continuous Manufacturing of BiologicsGovind Rao, PhD, Director, Center for Advanced Sensor Technology, University of Maryland, Baltimore County


1200–1210 Speaker IntroductionsWyatt Roth, PhD, Director, Small Molecule Design and Development, Eli Lilly and Company

1210–1230Leveraging Continuous Manufacturing to Enable Real Time Release Testing Joseph Medendorp, Senior Director, Technical Operations, Vertex

1230–1250Particle Design and Engineering to Enable Continuous Direct Compression Manufacturing ProcessesJeremy Merritt, PhD, Principal Research Scientist, Particle Design Lab—Small Molecule Design and Development, Eli Lilly and Company

1250–1310Janssen CM-strategy: A Story of Multiple Platforms From R&D to CommercialJeroen Geens, Engineering Technical Director—New Platforms, Janssen


1330–1400 Break



Program AgendaWednesday 3 June 2020 continuedWednesday 1400–1530 Concurrent Sessions



Analytics Considerations for Continuous Manufacturing Session Leader: Jeff Odum, CPIP, Head of Design, Technology and Standards, Biologics Engineering, Sanofi

Emerging Technologies Session Leader: Malcolm Berry, CEO and Founder, MB Chemistry Consulting, Ltd.

Session Description: This session will be a series of presentations related to analytics and release assays critical to successful implementation of CM. The session will include perspectives on emerging approaches for assessment of quality attributes, on release testing, and on the importance of process control and PAT.

Session Description: The session brings together industrial case studies from practitioners who have delivered innovative solutions to enable the adoption of continuous processing within their companies.

1400–1410Speaker IntroductionsJeff Odum, CPIP, Head of Design, Technology and Standards, Biologics Engineering, Sanofi

1410–1430Quality Considerations for the Multi-Attribute Method (MAM)Sarah Rogstad, Staff Fellow, Chemist, Office of Testing & Research, CDER, FDA

1430–1450Modern Microbiological Monitoring of Continuous ProcessingCheryl Essex, Head of Microbiological Control for Biologic Drugs, Sanofi

1450–1510Integrating Analysis with Process Control for the Continuous Bioprocessing: Extending the Lifecycle Concept to Process Analytical TechnologiesJosé C. Menezes, PhD, President and CEO, 4Tune Engineering Ltd

1510–1530Question and Answer/Discussion

1400–1410Speaker IntroductionsMalcolm Berry, CEO and Founder, MB Chemistry Consulting, Ltd

1410–1430Commercializing New Chemical Technologies in FlowMoiz Diwan, PhD, Director, Head of Enabling Technology Group, AbbVie

1430–1450Continuous Processing for the Manufacture of Active Pharmaceutical IngredientsMartin Johnson, PhD, Sr. Engineering Advisor, Eli Lilly and Company

1450–1510The Use of Kinetic Modelling to Define a Design Space for a Continuous ProcessPeter Shapland, PhD, Scientific Leader, R&D Medicinal Science and Technology, GSK Stevenage


1530–1615 Virtual Networking Session for Attendees, Speakers, and Exhibitors



Program AgendaThursday 4 June 2020 Thursday 1000–1130 Concurrent Sessions



Implementation Approaches for Large Molecule Continuous ManufacturingSession Leader: Lucy Chang, PhD, Executive Director, Global Regulatory CMC Biologics, Merck & Co., Inc.

Advances in Continuous Manufacturing for Small Molecule Session Leader: Bernhardt Trout, PhD, Professor of Chemical Engineering, MIT

Session Description: This session will be focused on the Integrated and Continuous Biomanufacturing process applied in the production of large molecules with experience shared by Sanofi, Pfizer and BI. This includes several areas including leveraging the at-scale data to support comparability studies as well as prePPQ campaigns, and Lifecycle Process Validation Considerations.

Session Description: While continuous processes started with a few continuous steps, the maximal value of continuous manufacturing will be gained from increased integration. Several recent processes demonstrate this value. This session will focus on actual industrial processes, emphasizing the technical and business advantages of integration. Advances in the integration of unit operations, independently for API and drug product as well as the end-to-end integration of the two will be discussed over the course of the session.

1000–1010Speaker IntroductionsLucy Chang, PhD, Executive Director, Global Regulatory CMC Biologics, Merck & Co., Inc.

1010–1030Lifecycle Process Validation Considerations for Large Molecule Continuous ManufacturingKatherine Giacoletti, Partner, SynoloStats LLC

1030–1050Leveraging ICB Technology for Novel Approaches to Process Performance QualificationKevin Brower, Head of Purification Development – US, Sanofi

1050–1110Development of an Integrated Manufacturing Process: The iSKID™Michael Jankowski, Associate Research Fellow, Analytical R&D, Pfizer Biotx Pharm Sci


1000–1010 Speaker IntroductionsBernhardt Trout, PhD, Professor of Chemical Engineering, MIT

1010–1030Full Integration of Continuous Manufacturing Sal Mascia, PhD, President and CEO, CONTINUUS Pharmaceuticals

1030–1050Mighty Machines: Integrating Design of Chemical Processes and Flow Reactor SystemsMatthew M. Bio, PhD, President and CEO, Snapdragon Chemistry

1050–1110Enabling End to End Continuous Manufacturing: FDA Perspective Sharmista Chatterjee, PhD, Division Director, Office of Pharmaceutical Manufacturing Assessment, CDER, FDA


1130–1200 Break



Program AgendaThursday 4 June 2020 continuedThursday 1200 – 1330 Concurrent Sessions



Perspectives on the Adoption and Implementation of Continuous ManufacturingSession Leader: Kelvin Lee, PhD, Professor of Chemical and Biomolecular Engineering, University of Delaware

Expert Roundtable: How do we realize the full potential for Small Molecule in the new decade? Session Leader: Michael O’Brien, PhD, Founder and President, NGT BioPharma Consultants and Gabriella Dahlgren, PhD, Manager, Strategy Deployment, Janssen Supply Group LLC

Session Description: This session will include 3 highly regarded experts in the CM for biological molecules. These experts will share perspectives and experiences on the development and potential adoption of CM for large molecules.

Session Description: Panel discussion with experts in the area of small molecule continuous manufacturing will discuss the technical, regulatory, and business hurdles for continuous manufacturing. This session will highlight CM as a continuum from E2E to hybrid approaches, including the need for “batch steps” for some products, requirement differences which can be a hindrance to global implementation of advanced technologies enabled by CM such as PAT, RTRT, and modeling; and why E2E CM may or may not be the optimal solution.

1200–1210Session Overview and Speaker IntroductionsKelvin Lee, PhD, Professor of Chemical and Biomolecular Engineering, University of Delaware

1210–1230Integrated Approach to Semi-Continuous Drug Substance ManufacturingMehdi Ghodbane, PhD, Downstream Process Development, Medicinal Science and Technology, GlaxoSmithKline

1230–1250N-1 Perfusion from Development through GMP Implementation Gene Schaefer, Senior Director Large Molecule API Development, Janssen

1250–1310Sanofi’s MA Digitalized Facility, an Ecosystem of the FutureNavin Tiwari, Director, Head of Digital Shop Floor and Automation, Sanofi


1200–1310Roundtable DiscussionPanelists: Gabriella Dahlgren, PhD, Manager, Strategy Deployment, Janssen Supply Group LLC Sharmista Chatterjee, PhD, Division Director, Office of Pharmaceutical Manufacturing Assessment, CDER, FDA Michael O’Brien, PhD, Founder and President, NGT BioPharma Consultants Liz Grieco, Director, Vertex Malcolm Berry, CEO and Founder, MB Chemistry Consulting, Ltd.


1330–1400 Break



Program AgendaThursday 4 June 2020 continuedThursday 1400–1530

Continuous Manufacturing for Emergency Preparedness and Rapid Response: Accelerating Widespread Adoption Session Leader: Christine M.V. Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.

Session Description: The onset of the COVID 19 pandemic has illustrated the importance of the FDA’s desired state of a “maximally efficient, agile, flexible pharmaceutical manufacturing sector”. Continuous manufacturing has the potential to rapidly respond to changes in demand due to local or global changes. Speakers in this session will discuss how government agencies, pharmacopeial organizations, and industry are working to advance continuous manufacturing and the potential of this technology to respond to the current situation and future challenges.

1400–1410Speaker IntroductionsChristine M. V. Moore, PhD, Conference Chair; Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.

1410–1430The Role of Advanced Manufacturing in Addressing Current Industry and Patient NeedsStelios Tsinontides, PhD, Director, Office of Pharmaceutical Manufacturing Assessment, CDER, FDA

1430–1445Preparing to be Prepared: How public standards and training can help respond to perturbations in the drug supply chain Atul Dubey, Director, Pharmaceutical Continuous Manufacturing, U.S. Pharmacopeia

1445–1455Strengthening our National Healthcare Supply Chain through Process IntensificationB. Frank Gupton, PhD, Floyd D. Gottwald Professor and Chair of the Department of Chemical and Life Science Engineering at the Virginia Commonwealth University School of Engineering

1455–1520Panel DiscussionPaul C. Collins, Senior Director, Small Molecule Design and Development, Eli Lilly and Company Anne Fischer, PhD, Program Manager, Defense Sciences Office, Defense Advanced Research Projects Agency (DARPA) Stelios Tsinontides, Director, Office of Pharmaceutical Manufacturing Assessment, CDER, FDA Atul Dubey, Director, Pharmaceutical Continuous Manufacturing, U.S. Pharmacopeia B. Frank Gupton, PhD, Floyd D. Gottwald Professor and Chair of the Department of Chemical and Life Science Engineering at the Virginia Commonwealth University School of Engineering

1520–1530Closing RemarksChristine M. V. Moore, PhD, Conference Chair; Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.

1530 Workshop Adjourns



Exhibitor List Media Partners

CPC1001 Westgate Drive, Saint Paul, MN 55114 USA

Julie [email protected]

952-693-5396www.cpcworldwide.com/bio

Bigfinite650 California Street, 7th floor, San Francisco, CA 94018 USA

Phil [email protected]

415-650-9103www.bigfinite.com

Supporting Sponsor

MilliporeSigma80 Ashby Road, Bedford, MA 01730 USA

1-800-645-5476www.emdmillipore.com

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2020 ispe continuous manufacturing virtual workshop

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