2018 ISPE Continuous Manufacturing Workshop

Interest in continuous manufacturing of pharmaceuticals has exploded in the past few years, fueled by the recent regulatory approvals of the first few drug products to be manufactured by this emerging technology. The 2018 ISPE Continuous Manufacturing Workshop will bring together industry practitioners, regulators and academics to discuss the recent successes and remaining challenges for continuous manufacturing of small molecule drug substances and drug products. The conference will provide an in-depth view of the manufacturing technologies and regulatory approaches for successful development, implementation, and lifecycle management of continuous manufacturing both for new molecules and for batch-to-continuous conversions.


Featured Topics

  • Communicating and Partnering with Regulators for Successful New Technologies
  • Control Strategies for Continuous Drug Products
  • Continuous Manufacturing of API: Network Capability, Flow Chemistry, and Executing at Commercial Scale
  • Continuous Process Verification for Continuous Manufacturing: Drug Product and Drug Substance
  • Continuous Separation and Purification for API
  • OSD Continuous Manufacturing Process/Equipment/Facility: Challenges and Opportunities
  • Quality Systems Considerations and the Impact of PAT and RTRT
  • Development Strategies for Continuous Manufacturing – Drug Product and Drug Substance

View Agenda


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

Who Should Attend?

  • Engineering Managers & Directors
  • Engineers
  • Operations
  • PAT Specialists
  • Plant Directors & Managers
  • Process Engineers
  • Project Managers
  • Regulators
  • Validation Specialists

Continuous Manufacturing Special Report

Returning for the first time since 2016, the 2018 ISPE Continuous Manufacturing Workshop will feature cutting-edge presentations from diverse industry front-runners, academic leaders, and regulatory experts who have influenced and implemented continuous manufacturing strategies and successfully launched products using the new technology.  Download the Special Report from the 2016 ISPE Continuous Manufacturing Conference to get a glimpse of what to expect at this year's workshop.

Download Special Report


Program Committee

Christine Moore Photograph
Chair: Christine Moore, PhD
Global Head & Executive Director
GRACS CMC - Regulatory Policy &
Compendial Affairs
Merck & Co.
Paul Collins Photograph
Paul Collins
Senior Director
Eli Lilly & Co
Celia Cruz Photograph
Celia Cruz, PhD
Director
Division of Product Quality Research
FDA
Lawrence De Belder Photograph
Lawrence De Belder
Senior Principal Engineer
Janssen Pharmaceuticals
Dave DiProspero Photograph
Dave DiProspero
Director of Pharmaceutical
Process Technology
CRB
Doug Hausner Photograph
Douglas Hausner, PhD
Associate Director for Industrial Relations and
Business Development
Rutgers University
Robert Perks, PhD Photograph
Robert Perks
Vice President, Operations
Werum IT Solutions
Eleni Dokou, PhD
Eleni Dokou, PhD
Senior Director, Formulation Development
Vertex Pharmaceuticals, Inc
Michael O’Brien, PhD
Michael O’Brien, PhD
Technology & Innovation Consultant
NextGenTech Pharma Consulting
Alastair Florence, PhD Photograph
Alastair Florence, PhD
Centre Director
Continuous Manufacturing and Advanced Crystallisation (CMAC) Research Hub