Conference Schedule

Wednesday, 13 November 2013

Plenary – Keynote
08.30 - 8.45 Introductions and Announcements; Overview and Meeting Objectives
08.45 - 9.45

Expanding Capabilities in Established Facilities

Britt Petty, Director MEF, Biogen Idec

New and Enabling Technologies
09.45 - 10.30

ISPE Guide: Biopharmaceutical Process Development and Manufacturing

Robert Dream, Principal, HDR COMPANY LLC

10.30 - 11.00 Networking Break
11.00 - 11.45 Key Challenges/Barriers to Further Implementation of Disposable  Technologies, Case Study: Risk Mitigation Strategies

Miriam Monge, Vice President Sales & Marketing, Biopharm Services Ltd
Dave Wolton, Biotechnology Consultant, PM Group
11.45 - 12.30 Improvement of Cell-Freezing Technologies and Disposable Bioreactors: Towards a Fully Closed USP Process

Aurore Lahille, New Technology Manager, Merck Biodevelopment
12.30 - 13.30 Lunch
13.30 - 14.15 Raw Material Science & Supply Chain Management for Enhanced Quality, Assurance of Supply & Change Control of Single Use Solutions

Katell Mignot, Head of Application Specialist SE & NEMEA, Sartorius Stedim Biotech
Carole Langlois, Product Manager, Sartorius Stedim Biotech
Driving Efficiency through Product Lifecycle
14.15 - 15.00 The Biopharmaceutical Challenge - From Process Development to Future Facilities

Paul Bird, Head of Development Engineering, Fujifilm Diosynth Biotechnologies
15.00 - 15.45 Technical Life Cycle Management

Philippe Ronse, Director, Head Technical Lifecycle Management, GlaxoSmithKline Vaccines
15.45 - 16.15 Networking Break
Plant Tours
16.15 - 18.00 Octapharma
Merck Millipore
18.00 - 22.00 Networking Evening

Thursday, 14 November 2013

Evolving Process Development Strategy
08.30 - 9.15 Bioprocess Models for Guiding Process Development and Enabling Efficient Communication Across the Organisation

Kai Touw, Process Engineer USP, Crucell / J&J
Wiebe van Vuure, Process Engineer DSP Development, Crucell / J&J
09.15 - 10.00 Developing Manufacturing Processes for Biosimilars

Hitto Kaufmann, Vice President Process Science, Boehringer Ingelheim
10.00 - 10.30 "Project EASE”
Constance Perrot, Operational Project Leader, European Aseptic and Sterile Environment Training Center
10.30 - 11.00 Networking Break
Facility Design
11.00 - 11.45 Pierre Fabre's New cGMP Clinical Facility for MAbs: a Highly Flexible, Cost Effective and Sustainable Design

Dr. Olivier Cochet, Director Industrial Biotechnology, Institut de Recherche Pierre-Fabre
11.45 - 12.30 Designing a Facility for Maximum Flexibility – A Three Years’ Experience in Full Plastics

Peter Rogge, Vice President USP Production, Rentschler Biotechnologie GmbH
12.30 - 13.30 Lunch
13.30 - 14.15 Pre-Packaged Facilities: Opportunities that Modularisation Might Provide

Thorsten Kimmel, Senior Process Engineer, F. Hoffmann-La Roche
Regulatory Developments and Focus
14.15 - 14.45 Common Regulatory Standards - EU vs. USA
14.45 - 15.15 Regulatory Forum
15.15 - 15.45 Networking Break
Facility Efficiency - Regulatory, GMP Challenges
15.45 - 16.30 Overview of the new ISPE Biopharmaceutical Facility Guide

Mark von Stwolinski, Vice President of Architectural Services, CRB Consulting Engineers, Inc.
16.30 - 17.15 Facility Efficiency - Regulatory, GMP Challenges Considering the Additional Risks of Operating BioTech Processes in a ‘Ball Room’ Facility

Robin Payne, Facilitator, BioPhorum
17.15 - 18.00

Risk Analysis and Mitigation Matrix (RAMM) - A Tool for Quality Risk Management

Daniel Abrahamsson, Validation Engineer Consultant, NNE Pharmaplan

18.00 - 18.15 Closing Remarks
18.15 Conference Adjourns

Plant Tours Agenda


Headquartered in Lachen, Switzerland, Octapharma Group is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for 30 years. Octapharma's core business is the development, production and sale of premium human proteins from human plasma and human cell-lines. Octapharma employs 5,000 people in 28 countries with sales of approximately €1 billion. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico. 

During your visit you will learn about Octapharma’s production (fractionation, purification, API, aseptic processes and facility and utilities onsite) as well as the operations of the plant.

16.15 - 16.30 Welcome
16.30 - 17.00

Plant Presentation 

F. CAMBECEDES & Video Presentation of Lingolsheim Plant

17.00 - 18.00

Visit L175 (NewGam)

Group A (15 max per group) 

Group B (15 max per group)

18.00 End of the Visit / Participants Departure

Merck Millipore

Merck Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers' success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, Merck Millipore serves as a strategic partner to customers and helps advance the promise of Life Science. Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 68 countries and 2010 revenues of $2.2 billion.

At the plant, you will visit a part of the demonstration lab. As part of the planned tour you will be able to see mixers, single-use bioreactors, chromatography columns and a clarification system.

16.15 - 16.30 Welcome the Participants
16.30 - 17.00

Group A (10 people max) : 
Single-Use Systems for Upstream (Single-Use Bioreactors 3, 50, 200L) 

Group B (10 people max) : 
Single-Use Systems for Chromatography and TFF

Group C (10 people max) : 
Single-Use Systems for Final Formulation and Filling

17.00 - 17.30

Group A (10 people max) : 
Single-Use Systems for Chromatography and TFF 

Group B (10 people max) : 
Single-Use Systems for Final Formulation and Filling 

Group C (10 people max) : 
Single-Use Systems for Upstream (Single-Use Bioreactors 3, 50, 200L)

17.30 - 18.00

Group A (10 people max) : 
Single-Use Systems for Final Formulation and Filling 

Group B (10 people max) : 
Single-Use Systems for Upstream (Single-Use Bioreactors 3, 50, 200L) 

Group C (10 people max) : 
Single-Use Systems for Chromatography and TFF

18.00 End of the Visit / Participants Departure

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