London, 3rd and 4th October 2018

Presentations

Where permission has been given, copies of the speaker presentations are available to view.

SESSION 1
Janet Woodcock, Modernizing Pharmaceutical Manufacturing: FDA View

Philip Dell’orco, GSK and Matthias Tix, Accenture , The State of Continuous Processing

Dr Salvatore Mascia of CONTINUUS, End-to-End Integrated Continuous Manufacturing: A Pilot Plant Implementation

SESSION 2
Professor Charles Cooney of MIT, An Integrating Framework for Continuous Bioprocessing

SESSION 3
Dr Jens Vogel of Boehringer Ingelheim, A Next Generation Platform for Integrated Continuous Manufacturing of Biopharmaceuticals

SESSION 4
Dr Charlotte Wiles of Chemtrix, Continuous Primary Processing – From an R&D Concept to Implementation at an Industrial Scale

Dr Peter Levison of Pall, Scale up of a Purification Platform for Manufacture of Biologics

Nicola Gandolfi of IMA S.p.A, Proxima and Croma, integrated technologies for Continuous Manufacturing

Vijay Kirpalani of Pi-Process, PI Techniques enabling advanced Continuous Manufacture of APIs

Thomas Steiner of Emerson, Addressing Controls Challenges in Flexible, Continuous Bio Manufacturing

SESSION 5
Dr Yoshihiro Matsuda of PMDA, PMDA Update

Dolores Hernan / Dr Peter Richardson of EMA, EMA Update

SESSION 6
Dr Andrew Rutter of GSK – GSK’s Progress to date on the business case for Primary Continuous:Small Agile Factories

Dr Mauricio Futran of Johnson & Johnson – Reflection on the Business Case of the First Batch to Continuous Manufacturing Converted Product Approved by the FDA

SESSION 7
Dr Roberto Pisano of Politecnico di Torino – Continuous Lyophilisation and its relevance to the production of Pharmaceuticals and Biopharmaceuticals

Dr Filipe Ataide – Scale-up of an exothermic reaction from lab to production scale

Dr Chris Price of University of Strathclyde – Establishing continuous isolation linking continuous synthesis with continuous formulation

SESSION 8
Celia Witten CBER’s Perspective on Advanced Manufacturing