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Informa
09:00 - 09:40 40 mins
Registration
09:40 - 09:50 10 mins
Chairperson's Opening Remarks
09:50 - 10:20 30 mins
Hot topics and challenges in raw materials for biologicals
  • Dominic Moore - Director, Quality Control Raw Materials Group, Sanofi Genzyme
10:20 - 10:50 30 mins
Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing
  • Dave Kolwyck - Director Manufacturing Science - Raw Materials, Biogen Idec, USA
10:50 - 11:20 30 mins
Info
Impact of impurities in industrial cell culture: Understanding and managing variation
  • Cory Card - Principal Scientist, Cell Culture, GE Healthcare

Highly defined bioproduction processes and the higher analytical resolution capabilities possible today allow for a much greater understanding of sources of variation and potential for risk mitigation.  An integrated, risk-based raw material characterization program is presented, including case studies illustrating how sources of variation affect process outcomes and actions that can mitigate risk and reduce process variation.

11:20 - 12:10 50 mins
Morning Coffee and Networking
12:10 - 12:40 30 mins
Info
Feedback from the ISIA on the use of serum in manufacturing
  • Rosemary Versteegen, PhD - CEO, ISIA
  • Serum/ removal of the use of serum
  • HPV concerns and considerations
  • Reg recommendations 
12:40 - 13:10 30 mins
Spectroscopic online monitoring methods to identify the impact of preparation parameters and raw materials on chemically defined cell culture media quality
  • Andreas Unsöld - Head of Cell Culture Media, Boehringer Ingelheim
13:10 - 13:40 30 mins
Info
Utilizing the Joint Audit Approach for Single Use Systems
  • Jim Fries - CEO, RX-360

Background:

The BioPhorum Group in conjunction with Rx-360 have identified the current value of joint audits throughout the industry.  In an effort to bring the joint audit model to single use systems.  The purpose of the pilot is to validate the joint audit model within the auditing process of single use systems.  Through this Pilot BPOG and Rx-360 will also be able to validate best practices around cost effect, quality based joint audits and the alleviation of supplier burden during the audit process.


Methods:

Rx-360 and BioPhorum will utilize BSI to conduct the audits that are scheduled within the Pilot.  The Pilot is being driven by a Steering Committee that is made up of members of all three organizations.  Those members will collaboratively drive the Pilot planning stage through analysis of data, and implementation of best practices or improvements.  The Pilot will identify “Reviewers” who will take on the traditional role of cosponsors of the audit, as described within the current Joint Audit Model.  The Pilot will be made up of 12 audits that will be broken up into 4 “sprints or sections of 3 audits each.  Key measures that will be tracked during Pilot are:

  • The delivery of final audit report within 30 business days
  • The number of times a completed audit is licensed
  • CAPA compliance (20 days)
  • Reduction in supplier audit burden as measured by planning time, hosting time, responding to and reviewing multiple audits and all associated costs.
  • Survey feedback from participants
  • Observations identified during Pilot as categorized as Potentially Critical and/or Other.


Outcome of Pilot:

Upon completion of the Pilot, a collaborative team identified by Rx-360 and BioPhorum will write a consensus paper (to be published) that will provide the results, and data of the Pilot. 


Presentation Goal:

To provide an Overview of entire program and for the first time publicly present results of the initial phase of the Pilot.

13:40 - 14:10 30 mins
Spotlight Presentation
14:10 - 15:30 80 mins
Lunch and Networking Break
15:30 - 16:00 30 mins
Cell Free Expression of Highly Toxic Proteins
  • David Gruber - Head of Downstream Process Development, Ipsen
16:00 - 16:30 30 mins
Development of an In-House Cell Free Extract Process and Robotic Platform for Expression Optimisation
  • Philip Probert, PhD - Senior Upstream Scientist, National Biologics Manufacturing Centre, Center for Process Innovation
16:30 - 17:00 30 mins
Large Scale, Closed Loop, Production of DNA Product Without Cells
  • Shyam Thapa - Manufacturing Development Scientist, Touchlight Genetics Ltd
17:00 - 17:30 30 mins
Info
Industry 4.0 in Aviation – Digitalization without beta versions
  • Sven Taubert - Head of Corporate Foresight & Market Intelligence, Lufthansa Technik AG

Topics like Digitalization and Industry 4.0 are currently on everyone's minds. New economy companies revolutionizing more and more classical business models. Aviation, like other safety sensitive industries, is working hard to keep up. Unlike services from the big role models out of e.g. Silicon Valley, aerospace products cannot and will not shipped in Beta status. This presentation will show examples how Lufthansa is addressing these challenges.

17:30 - 19:30 120 mins
Opening of Exhibition Hall & Networking Drinks