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LEARNING FROM THE BEST AND BRIGHTEST

ECCPM organizes regular events where the consortium members and invited external experts can discuss key CM topics contributing with relevant results and state-of-the-art thinking. These events are a very important networking opportunity for people working in continuous pharmaceutical manufacturing, and set the frame for the development of common language and strategies.

While our workshops are on invitation only, our yearly forum is open to attendees and companies from all pharmaceutical organizations.

 ECCPM FORUM 2019 

DIGITAL MANUFACTURING

September 26, 2019

Focus of this forum were industry experiences with theoretical vs experimental approaches for regulatory support. The event, organized by RCPE in co-operation with Life Science Integrates, featured 4 sessions and a total of 10 speeches, and was attended by over 60 participants from 33 different companies and 12 different countries. Sean Bermingham, Head of Formulated Products at PSE, commented “For me the highlight of the event was to see convergence of mechanistic modelling approaches and data-driven approaches. There is a growing awareness that mechanistic modelling is necessary because big data are usually not available and we want to use data-driven approaches to fill the gap, and be able to develop processes more efficiently and more effectively.”

KEYNOTE SPEAKERS:

Avik Sarkar (Pfizer)
Matt Metzger (MSD)

TOPICS

  • Overview of the tools used by industry to develop continuous processes
  • Examples for experimental and simulation-based approaches
  • Influence of materials on the process and how to cluster this large amount of information
  • Material science
  • Development of a model based process design applying model predictive control
  • Regulatory requirements and opportunities in the field of CM and associated process control

 ECCPM FORUM 2017 

IMPLEMENTATION OF CONTINUOUS PROCESSES IN AN INDUSTRIAL ENVIRONMENT

September 21, 2017

This workshop introduced the necessary requirements for setting-up and implementing a continuous manufacturing process in a pharmaceutical environment, including regulatory approval. We shared examples of existing CM processes and lessons learned for a successful CM implementation.

KEYNOTE SPEAKERS:

Oyvind Holte (Norwegian Medicines Agency)
Martin Warman (Consultant at UCB)
Chris Price (CMAC)
Jim Holman (GEA)
Giustino Di Pretoro (Janssen)

TOPICS

  • Implementation of a CM process in a production environment
  • Lessons learned from process development and regulatory submission
  • Considerations for PAT tools in CM
  • Fit-for-purpose process control
  • Regulatory requirements and opportunities in the field of CM and associated process control

 ECCPM FORUM 2016 

FROM PROCESS UNDERSTANDING TO CONTROL STRATEGY

July 4, 2016

CM control strategies demand a sound process understanding by determining the link between process parameters, material attributes and product quality attributes, supported by modeling and simulation. This workshop focused on recent advances and modern approaches by demonstrating how advanced process control can be applied and implemented, and the benefits achieved.

KEYNOTE SPEAKERS:

Dr. Rohit Ramachandran (Rutgers University)
Mauricio Futran, Ph.D. (Janssen Supply Group)
Prof. Horn (University of Technology Graz)
Dr. Jochen Thies (Glatt)
Dr. Ivo Backx (Siemens)
Sean Bermingham (PSE)

TOPICS

  • Continuous manufacturing process control, important prerequisites
  • Control strategies designed for continuous manufacturing
  • Fit-for-purpose process control
  • Regulatory requirements and opportunities in the field of CM and associated process control

 ECCPM FORUM 2015 

ADVANCED PAT AND REAL-TIME RELEASE

September 16 – 17, 2015

The focus of this event was RTRT, its prerequisites and how it can be implemented, supported by the recent developments in the field of PAT, process monitoring and visualization.

KEYNOTE SPEAKERS:

Steve Hammond (Pfizer)
Sonja Sekulic (Pfizer)
Martin Warman (Vertex Pharmaceuticals)

TOPICS

  • Development of a risk-based PAT strategy: from sensors to Real Time Release (RTR)
  • Definition of the relevant CPPs and CQAs for monitoring
  • Definition of the necessary advanced measuring systems
  • Regulatory aspects of RTR, data handling and measurement systems
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