Integrating Process Development: Upstream and Downstream Technology

Monday, February 25, 2013, 1:30pm-3:40pm PST

Talks in this session will include new approaches to process development in both upstream and downstream areas that together present significant improvements to speed in the development and implementation of commercial drug substance processes. The use of automation and high-throughput systems, accelerated learning through data capture and mining, more reliable scale-down models and potentially disruptive technologies are examples of topics that should be considered for talks and discussion.

Session Co-Chairs:

  • Brian Kelley, Genentech

  • Nigel Titchener-Hooker, University College London

Confirmed Speakers

  • Gene Schaefer, Johnson & Johnson: Challenges and Innovative Approaches to Improving the Efficiencies of Process Development and Tech Transfer
  • Rohin Mahtre, Biogen Idec: Enhancing Efficiency and Control for a Biopharamaceutical Manufacturing Process
  • Mike Hoare, University College London: Speeding Whole Bioprocess Solutions: the Crucial Interface Linking the Bioreactor to Purification
  • Dean Pettit, Amgen: Upstream and Downstream Strategies to Actively Control of Product Quality Attributes

Eugene Schaefer

Dr. Gene Schaefer is currently Senior Director, API Large Molecule Pharmaceutical Development & Manufacturing Sciences at Johnson & Johnson in Malvern, PA.  In this role he is responsible for a number of projects from early stage process development to commercial product support for protein therapeutics.

Prior to joining Johnson & Johnson in 2008, Dr Schaefer was Director, Process Technologies, for seven years in the Protein Therapeutics Development group at Bristol-Myers Squibb Co. in Hopewell, New Jersey responsible for the process development and early clinical...