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

Opening Plenary: A New Decade for Continuous Manufacturing

Jun 3, 2020 10:00am ‐ Jun 3, 2020 11:30am

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.

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):

Current Status on CM for Biologics: Development to Clinical

Jun 3, 2020 12:00pm ‐ Jun 3, 2020 1:30pm

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.

Moderator(s):
  • Antonio 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 3, 2020 12:00pm ‐ Jun 3, 2020 1:30pm

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!

Moderator(s):
  • Wyatt Roth, PhD, Senior Research Scientist, Eli Lilly and Company
Speaker(s):

Emerging TechnologiesEmerging Technologies

Preview Available

Emerging Technologies

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

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

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 3, 2020 2:00pm ‐ Jun 3, 2020 3:30pm

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.

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

Implementation Approaches for Large Molecule Continuous Manufacturing

Jun 4, 2020 10:00am ‐ Jun 4, 2020 11:30am

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 prePPQ campaigns, and lifecycle process validation considerations.

Moderator(s): Speaker(s):

Advances in Continuous Manufacturing for Small Molecule

Jun 4, 2020 10:00am ‐ Jun 4, 2020 11:30am

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.

Moderator(s): Speaker(s):

Perspectives on the Adoption and Implementation of Continuous Manufacturing

Jun 4, 2020 12:00pm ‐ Jun 4, 2020 1:30pm

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.

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

Expert Roundtable: How Do We Realize the Full Potential for Small Molecule in the New Decade?

Jun 4, 2020 12:00pm ‐ Jun 4, 2020 1:30pm

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.

Moderator/Speaker(s): Speaker(s):

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

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

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.

Moderator/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
Print Certificate
Completed on: token-completed_on
Print Transcript
Please select the appropriate credit type:
/
test_id: 
credits: 
completed on: 
rendered in: 
* - Indicates answer is required.
token-content

token-speaker-name
token-index
token-content
token-index
token-content
token-index
token-content
token-index
token-content
token-index
token-content
token-index
token-content
/
/
token-index
token-content
token-index
token-content