08:30 Chairman’s Opening Remarks

08:40 Keynote Presentation: Single Use Systems – Past, Present and Future

Single use systems have been used in the industry for over 25 years, however over the 10 years the use of these products have become increasingly adopted within the industry and over the last five all the main equipment suppliers have sought to be able to provide complete disposable complete disposable solutions for bio-production system. However it is apparent that whilst in some area of the biopharm business, such as the production of products for early stage clinical trials there have been lower levels of adoption of these products for the production of in-market products.

• Reflecting on the history of single use products in biopharmaceutical production systems
• Analyzing the hurdles that exist in the greater adoption of these systems in for example the production of in-market products
• Examining how these technologies may be used in the production of current and future biotechnology based products

Tony Hitchcock
Head of Manufacturing Technologies
Cobra Biologics

09:20 Economic Comparison between Stainless Steel and Disposable Systems

• Identify technical risk to implement disposable solutions
• Analysis of total cost of ownership
• Define scope and resources required to support the change from the current step to single use

Dr. Karen Wen
President
Mycenax Biotech

10:00 SPEED NETWORKING

Speed networking will enable you to meet all conference attendees within a short time and ensure an open discussion throughout the conference

10:50 Assessing Quality and Regulatory Challenges of Single Use Systems

• Regulatory implications for single use systems
• Validation expectations for single use systems
• Material compatibility and harnessing advantages of single use systems

Shelly Huang
Associate Director of Quality and Regulatory Affair, A-BIo Pharma (Former) President & CEO
BIO-TECH CAPITAL Pte Ltd.

11:30 Pragmatic Implementation of Single-use Technologies

Steve Vermant
Head of Field Marketing - Asia Pacific Biopharm Process Solution
Merck Millipore

13:30 ROUND TABLE DISCUSSION

You can choose to attend one of three informal discussion sessions, depending on your goals and strategies. Join our resident experts for a no holds barred, frank discussion on the topic of your choice.

• Selecting and Integrating a Single Use Bioreactor
• Getting the Right Data from your Extractable and Leachable Studies
• Automation of Single Use Systems
• Where there is need and added value?
• Integrate sensors and pumps into equipment, in order to make your system more compact, easier to handle and more cost effective.

14:00 PANEL DISCUSSION: Taking a Collaborative View of Quality Control

There will be two main themes of this cross-sector panel, where industry experts and suppliers will come together and discuss how to assess the liability of suppliers and end users through implementing inspection and audit programmes and ensuring effective change management. Experts will look at the various approaches to sampling and testing of single use sterile devices

14:40 CASE STUDY: Setting up a New Plant from Design Concept to Implementation

• How to develop routines that provides an overview of the growing Embed flexibility into the new pilot plant?
• Overcome the barriers of technology and process transfer
• Designing the process before the building of single-use facility
• How to work with suppliers from scratch to design a fully disposable facility?

Dr. Michael Lee
VP, Production
TDW Pharmaceuticals

15:50 The Disposable Facility and Single-Use Technology - a Solution or a Revolution?

• Examining the advantages and limitations of Single-use Technology
• Understanding improvement of process robustness
• How does it contribute to Lean Production?
• Environmental impact of disposables

Dr. Joachim K Walter
SVP Biopharmaceutical Operations
Innobiologics Sdn Bhd

16:20 PANEL DISCUSSION –Taking the Next Step: From Pilot Plants to Global Scales

This panel will bring industry professionals together to discuss the future strategies and capabilities of disposable manufacturing systems. It is a perfect opportunity to find out how others are planning this next step and to share best practice and alternative operation models.

17:00 Closing remarks from the Chair & End of Conference