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

Dean Pettit

Dean is the site head for the Drug Substance Development function within the company’s Process and Product Development (P&PD) organization in R&D.  His responsibilities include directing a department in the areas of Cell Science and Technology, Purification Process Development, Analytical Sciences, and Functional Biocharacterization.  He works on directing the development of IgG1 and IgG2 antibody products and other fusion protein products.  He began his industrial career at Allergan in 1983 as a Research Engineer developing ocular implants and medical devices.  In 1993, Dean...

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...

Mike Hoare

Professor of Biochemical Engineering, UCL, London, heads up research and novel knowledge transfer programmes into novel ultra scale-down technologies for the early stage discovery of whole bioprocessing for biopharmaceuticals, vaccines and human cell therapies. Awarded the Donald Medal for Biochemical Engineering and the Dunnill bioProcessUK prize for outstanding contribution to UK bioprocessing. 

Rohin Mahtre

Rohin Mhatre has worked in the biotech industry for the past 18 years. In his current role at Biogen Idec as Vice President of Technical Development, he oversees upstream/downstream process development, formulation, analytical and device development for all the biological molecules. His areas of interest are in QbD/PAT and he has published and presented on these topics.