London, 3rd and 4th October 2018


2018 CMAC-MIT 3rd Symposium Agenda

Continuous Manufacturing: Implementation, Integration and Regulatory Approaches


Day 1 | 3rd October 2018


07.15 - 08.15Breakfast & Registration
08.15 - 08.30Symposium Introduction

Professor Bernhardt Trout of MIT & Dr Clive Badman of University of Strathclyde
08.30 - 09.15KEY NOTE SPEAKER:

Dr Janet Woodcock of the FDA – Director, Center for Drug Evaluation and Research

FDA stance on advanced manufacturing

Session 1: Overview of Industrial progress on the introduction of CM for Small Molecules

Chair: Professor Alastair Florence of CMAC, University of Strathclyde

09.20 – 09.45
Dr Phillip Dell’Orco of GSK and Matthias Tix of Accenture

The State of Continuous Processing
09.45 – 10.05
Raymond Boyse of Eli Lilly

An industry demonstration of small volume GMP continuous manufacturing of drug substance
10.05 – 10.25
Daniel Blackwood of Pfizer

PCMM Case Study: Key Learnings and Insights from Implementing a CM Platform Technology
10.25 – 10.45Dr Salvatore Mascia of CONTINUUS

End-to-End Integrated Continuous Manufacturing: A Pilot Plant Implementation
10.45 - 11.15Coffee & Networking Break

Session 2: Bioprocessing ‘Technology & Implementation successes at larger GMP scale’

Chair: Dr Konstantin Konstantinov of Codiak Bio

11.15 – 11.55Professor Charles Cooney of MIT

An Integrating Framework for Continuous Bioprocessing
11.55 - 12.20Dr Franqui Jimenez of Sanofi

Commercializing Second-Generation Continuous Manufacturing: A Sanofi Case Study
12.20 - 12.45Dr Raghavan Venkat of Medimmune

MedImmune’s journey into continuous bio-processing: Challenges and Opportunities
12.45 - 13.45Lunch

Session 3: Bioprocessing follow up on Session 2

Chair: Professor Charles Cooney of MIT

13.45 – 14.10Dr Jens Vogel of Boehringer Ingelheim

A Next Generation Platform for Integrated Continuous Manufacturing of Biopharmaceuticals
14.10 - 14.35Professor Massimo Morbidelli of ETH, Zurich

Development of an integrated production platform for the end-to-end production of a monovalent therapeutic protein
14.35 - 15.00Industry Panel Session:
- Professor Massimo Morbidelli of ETH
- Dr Veena Warikoo of Roche
- Dr Aine Hanly of Amgen
- Dr Raghavan Venkat of Medimmune
- Dr Jens Vogel of Boehringer Ingelheim
15.00 - 15.30Coffee & Networking Break

Session 4: Vendor Overview on New Continuous Technologies

Chair: Craig Johnston of CMAC, University of Strathclyde

15.35 – 15.50Dr Charlotte Wiles of Chemtrix

Continuous Primary Processing - From an R&D Concept to Implementation at an Industrial Scale
15.50 – 16.05Dr Peter Levison of Pall

Scale-up of a Continuous Purification Platform for Manufacture of Biologics
16.05 – 16.20Nicola Gandolfi of IMA S.p.A

Prexima and Croma, integrated technologies for Continuous Manufacturing
16.20 – 16.35Ivo Backx of Siemens

Added value of the partnership of Siemens, PSE and Perceptive Engineering to bring continuous pharmaceutical manufacture faster to market
16.35 – 16.50Vijay Kirpalani of Pi-Process

PI Techniques enabling advanced Continuous Manufacture of APIs
16.50 – 17.05Thomas Steiner of Emerson

Addressing Controls Challenges in Flexible, Continuous Bio Manufacturing
17.05 - 17.30Pharma Manufacturing Technology Review User Panel

- Dr Massimo Bresciani of RCPE
- Dr Douglas Hausner of C-SOPS
- Dr Jon-Paul Sherlock of AstraZeneca
- Dr Robert Meyer of Merck
- Jo Pisani of PwC
17.30 - 17.40Day 1 Wrap up
17.40 - 17.45Remedies White Paper Dissemination
17.45 - 19.00Wine & Hors D’oeuvres Reception & Poster Session


Day 2 | 4th October 2018


07.30 - 08.20Breakfast & Registration
08.20 - 08.30Reflections on Day 1

Professor Bernhardt Trout of MIT & Dr Clive Badman of University of Strathclyde

Session 5: Regulatory Presentations

Chair: Dr Moheb Nasr of NPRC
08.35 – 08.50Dr Peter Richardson of EMA

EMA Update
08.50 – 09.05Dr Larry Lee of FDA

USFDA Update
09.05 – 09.20Dr Yoshihiro Matsuda of PMDA

PMDA Update
09.35 - 09.50Dr Markus Krumme of Novartis

An Industry Perspective on Regulatory Progress and Challenges
09.50 - 10.45Panel Discussion
10.45 - 11.05Coffee & Networking Break

Session 6: Business Case & Supply Chain Implementation

Chair: Dr Clive Badman of University of Strathclyde

11.05 – 11.17Dr Mauricio Futran of Johnson & Johnson

Reflection on the Business Case of the First Batch to Continuous Manufacturing Converted Product Approved by the FDA
11.17 – 11.29Dr Andrew Rutter of GSK

GSK’s progress to date on the business case for Primary Continuous : Small Agile Factories.
11.29 – 11.41Dr Jag Srai of IfM Cambridge

Evaluating the Business Case for Continuous Processing- A Supply Chain Perspective
11.41 – 11.53Professor Suzanne S Farid of University College London
Process economics perspectives of continuous manufacture for mAbs and vaccines
11.53 – 12.05Dr Paul Collins of Eli Lilly

Speed, Efficiency and Higher Assurance of Quality Control- Implementation of Continuous Direct Compression at Eli Lilly and Co.
12.05 – 12.35Panel Discussion
12:35 - 12:40ADDoPT Dissemination
12.40 - 13.35Lunch
13.35 - 13.50Professor Rex Reklaitis, Purdue University

Challenges in Continuous Manufacturing of Biologics: Summary of NASEM Workshop

Session 7: Making the Future of Continuous Manufacturing

Chair: Professor Bernhardt Trout (MIT)

13.50 – 14.02Dr Matt Bio of Snapdragon

One Process from Milligrams to Kilograms; Efficient Drug Substance Development Enabled by Continuous Manufacturing Technology.
14.02 - 14.14Declan Moran of IPSEN

Adapting Continuous Flow to Peptide Manufacture
14.14 - 14.26Dr Filipe Ataíde of Hovione

Scale-up of a reaction step from lab to commercial scale, switching from batch to continuous manufacturing using a mechanistic modelling approach
14.26 – 14.38Dr Chris Price of University of Strathclyde

Establishing continuous isolation linking continuous synthesis with continuous formulation
14.38 – 14.50Professor Johannes Khinast of Graz University of Technology

Digital design of products and processes in the context of continuous manufacturing
14.50 - 15.20 Industry & Academia Panel Discussion
15:20 - 15:35 Coffee & Networking Break

Session 8: Emerging Innovation in Continuous

Chair: Professor Charles Cooney (MIT)

15.35 – 16.00KEYNOTE SPEAKER
Dr Celia Witten, Deputy Director of CBER

‘CBER’s Perspective on Advanced Manufacturing’
16.00 – 16.05Chair: Professor Charles Cooney
16.05 – 16.20Dr Konstantin Konstantinov of Codiak Bio

Continuous Manufacturing of Exosomes for Large Scale Therapeutic Applications
16.20 – 16.35Dr Roberto Pisano of Politecnico di Torino

Continuous Lyophilisation and its relevance to the production of Pharmaceuticals and Biopharmaceuticals
16.35 - 16.45Symposium Conclusion & Proposed Next Steps