2020 ISPE Continuous Manufacturing Virtual Workshop

Jun 3, 2020 ‐ Jun 4, 2020


Learning Objectives

  • Understand the current status of small molecule drug substance and drug product continuous manufacturing efforts
  • Recognize the supply chain, safety and quality assurance advantages provided by continuous manufacturing
  • Compare different approaches to continuous manufacturing regarding equipment, measurement tools, and control strategies
  • Appreciate avenues for enhanced communication with regulators on innovative and emerging technologies


Sessions

Continuous Manufacturing for Emergency Preparedness and Rapid Response: Accelerating Widespread Adoption

Jun 4, 2020 2:00pm ‐ Jun 4, 2020 3:30pm

Continuous Manufacturing for Emergency Preparedness and Rapid Response: Accelerating Widespread Adoption|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.  This session will close with an extended panel discussion.

Leader/Speaker(s):
  • Christine Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.
Speaker(s):
  • Stelios C. Tsinontides, PhD, FAIChE, Director, Office of Pharmaceutical Assessment, CDER/FDA
  • Atul Dubey, PhD, Director, Pharmaceutical Continuous Manufacturing, USP Reference Standards Labs
  • B. Frank Gupton, PhD, Floyd D. Gotttwald Professor & Chair, Chemical & Life Science Engineering, Virginia Commonwealth University
  • Anne Fischer, PhD, Programs Manager, Defense Science Office, Defense Advanced Research Projects Agency (DARPA)
  • Paul Collins, PhD, Senior Director, Small Molecule Design and Development, Eli Lilly and Company

A New Decade for Continuous Manufacturing

Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

A New Decade for Continuous Manufacturing

A New Decade for Continuous Manufacturing 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.

  • Welcome and Opening Remarks
    Christine M. V. Moore, PhD, Conference Chair; Global Head and Executive Director, GRACS CMC Policy
    Merck  
  • Speaker Introductions
    Sharmista Chatterjee, PhD, Division Director
    OPMA, OPQ/CDER
  • ICH Q13 Guidance – Continuous Manufacturing of Drug Substance and Drug Product
    JRapti Madurawe, PhD, Division Director
    FDA/CDER/OPQ/OPPQ
  • End to End Collaboration to Transform Biopharmaceutical Development & Manufacturing
    John Erickson, PhD, Senior Fellow,
    National Institute for Innovation in Manufacturing Biopharmaceuticals NIIMBL
  • Perspectives on the Implementation of Continuous Manufacturing 
    Sarah O’Keefe, PhD, VP Small Molecule Design and Development
    Eli Lilly and Company

Moderator(s):
  • Christine Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.
  • Sharmista Chatterjee, PhD, Division Director, OPF, and Emerging Technology Team Member, CDER/FDA
Speaker(s):

Implementation Approaches for Large Molecule

Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Implementation Approaches for Large Molecule

Implementation Approaches for Large Molecule Continuous Manufacturing This session will focus on the integrated and continuous biomanufacturing process applied in the production of large molecules with experience shared by Sanofi, Pfizer and BI. Several areas will be discussed including leveraging the at-scale data to support comparability studies, as well as pre PPQ campaigns, and lifecycle process validation considerations.

  • Lifecycle Process Validation Considerations for Large Molecule Continuous Manufacturing
    Katherine Giacoletti, Partner
    SynoloStats LLC  
  • Leveraging ICB Technology for Novel Approaches to Process Performance Qualification
    Kevin Brower, Head of Purification Development
    US Sanofi
  • Development of an Integrated Manufacturing Process: The iSKID™
    Michael Jankowski, associate Research Fellow, Analytical R&D
    Pfizer Biotx Pharm Sci

Moderator(s): Speaker(s):

Current Status on CM for Biologics: Development to Clinical

Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Current Status on CM for Biologics: Development to Clinical

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.

  • The Biopharmaceutical Industry Emerging Continuous and Integrated Platform for Recombinant Protein Jon Coffman, PhD, Senior Director of Bioprocess Technology and Engineering AstraZeneca
  • Perspectives on the Development of Continuous Manufacturing for Biological Products
    Mark Brower, Principal Scientist
    Merck
  • Novel Technologies to Enable Continuous Manufacturing of Biologics
    Govind Rao, PhD, Director, Center for Advanced Sensor Technology
    University of Maryland, Baltimore County

Moderator(s):
  • Antonio R. Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland, Baltimore County
Speaker(s):
  • Jon Coffman, PhD, Senior Director of Bioprocess Technology and Engineering, AstraZeneca
  • Mark Brower, Principal Scientist, Merck & Co., Inc.
  • Govind Rao, PhD, Professor & Director, Center for Advanced Sensor Technology, University of Maryland, Baltimore County

Success Stories From Small Molecule Drug Product

Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Success Stories From Small Molecule Drug Product

Success Stories From Small Molecule Drug Product 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!

  • Leveraging Continuous Manufacturing to Enable Real Time Release Testing
    Joseph Medendorp, Senior Director, Technical Operations
    Vertex  
  • Particle Design and Engineering to Enable Continuous Direct Compression Manufacturing Processes
    Jeremy Merritt, PhD, Principal Research Scientist, Particle Design Lab – Small Molecule Design & Development
    Eli Lilly and Company Janssen
  • CM-strategy: A Story of Multiple Platforms From R&D to Commercial
    Jeroen Geens, Engineering Technical Director – New Platforms
    Janssen

Moderator(s):
  • Wyatt Roth, PhD, Senior Research Scientist, Eli Lilly and Company
Speaker(s):
  • Joseph Medendorp, PhD, Senior Director, Technical Operations, Vertex
  • Jeremy Merritt, PhD, Principal Research Scientist, Eli Lilly and Company
  • Jeroen Geens, PhD, Engineering Technical Director, New Platforms, Janssen Research & Development

Emerging TechnologiesEmerging Technologies

Preview Available

Emerging Technologies

Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Emerging Technologies

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

  • Commercializing New Chemical Technologies in Flow
    Moiz Diwan, PhD, Director, Head of Enabling Technology Group
    AbbVie  
  • Continuous Processing for the Manufacture of Active Pharmaceutical Ingredients
    Martin Johnson, PhD, Sr. Engineering Advisor
    Eli Lilly & Company
  • The Use of Kinetic Modelling to Define a Design Space for a Continuous Process
    Peter Shapland, PhD, Scientific Leader, R&D Medicinal Science & Technology
    GSK Stevenage

Moderator(s):
  • Malcolm Berry, PhD, Continuous Chemistry Team Manager, MB Chemistry Consulting, Ltd.
Speaker(s):
  • Moiz Diwan, PhD, Director, Pharmaceutical Development Research & Development, AbbVie
  • Martin Johnson, PhD, Sr. Engineering Advisor, Eli Lilly and Company
  • Peter Shapland, PhD, Scientific Leader, R&D Medicinal Science and Technology, GSK Stevenage

Analytics Considerations for Continuous Manufacturing

Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Analytics Considerations for Continuous Manufacturing

Analytics Considerations for Continuous Manufacturing 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.

  • Quality Considerations for the Multi-Attribute Method (MAM)
    Sarah Rogstad, Staff Fellow, Chemist
    FDA
  • Modern Microbiological Monitoring of Continuous Processing
    Cheryl Essex, Head of Microbiological Control for Biologic Drugs
    Sanofi
  • Integrating Analysis with Process Control for the Continuous Bioprocessing: Extending the Lifecycle Concept to Process Analytical Technologies
    Jose C. Menezes, PhD, President and CEO
    4Tune Engineering Ltd

Moderator(s):
  • Jeffery Odum, CPIP, Head of Design, Technology & Standards, Biologics Engineering, Sanofi
Speaker(s):

Advances in Continuous Manufacturing for Small Molecule

Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Advances in Continuous Manufacturing for Small Molecule

Advances in Continuous Manufacturing for Small Molecule 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.

  • Full Integration of Continuous Manufacturing
    Sal Mascia, PhD, President and CEO
    CONTINUUS
  • Mighty Machines; Integrating Design of Chemical Processes and Flow Reactor Systems
    Matthew M. Bio, PhD, President and CEO
    Snapdragon Chemistry
  • Enabling End to End Continuous Manufacturing: FDA Perspective
    Sharmista Chatterjee, PhD, Division Director
    OPMA, OPQ/CDER

Moderator(s): Speaker(s):

Perspectives on the Adoption and Implementation

Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Perspectives on the Adoption and Implementation

Perspectives on the Adoption and Implementation of Continuous ManufacturingThis 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.

  • Integrated Approach to Semi-Continuous Drug Substance Manufacturing
    Mehdi Ghodbane, PhD, Downstream Process Development, Medicinal Science & Technology
    GlaxoSmithKline  
  • N-1 Perfusion from Development through GMP Implementation
    Gene Schaefer, Senior Director Large Molecule API Development
    Janssen
  • Sanofi’s MA Digitalized Facility, an Ecosystem of the Future
    Navin Tiwari, Director, Head of Digital Shop Floor & Automation
    Sanofi

Moderator(s):
  • Kelvin Lee, PhD, Director and Professor, Chemical & Biomolecular Engineering, Univ. of Delaware, NIMBL
Speaker(s):

Expert RoundtableExpert Roundtable

Preview Available

Expert Roundtable

Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Expert Roundtable

Expert Roundtable: How do we realize the full potential for Small Molecule in the new decade? 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.        

  • Malcolm Berry, PhD, CEO & Founder MB
    Chemistry Consulting, Ltd.    
  • Sharmista Chatterjee, PhD, Division Director OPMA,
    OPQ/CDER  
  • Gabriella Dahlgren, PhD, Manager, Strategy Deployment
    Janssen Supply Group LLC      
  • Elizabeth Grieco, Director Vertex  
  • Michael O’Brien, PhD, Founder and President NGT
    BioPharma Consultants

Leader/Speaker(s): Speaker(s):
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