Full Conference Details Inside

Friday, October 12, 2012
7:00 Networking Coffee
7:30 Technology Workshop with Light Continental Breakfast Sponsored by:
New Tools for High Throughput Analysis in Biopharmaceutical Development
This talk presents applications of the AssayMAP high throughput microchromatography platform for automated sample preparation prior to various protein/peptide analytical methods.
The system can purify protein products from complex samples for quantitation and downstream analysis. A major application is automated sample preparation for N-glycan profiling,
including enzymatic digestion, fluorescent labeling and cleanup. Peptide mapping will also be shown.
Scott P. Fulton, MSc., Head, AssayMAP Operations & Workflow Development, Agilent Technologies, Inc.
8:00
8:15
8:45
9:15
Cell Culture Process Development for Novel Molecules
and Next Generation Protein Therapeutics
Chairperson’s Opening Remarks
Kathie Fritchman, Manager, BioProcess Application - Advanced Bioprocessing, BD Biosciences
Expression, Purification and Characterization of an IL-1
CASE STUDY
Therapeutic Inhibitor
UNPUBLISHED
DATA
Gregory Zarbis-Papastoitsis, Ph.D., Senior Director, Protein Production and Analytical
Development, Eleven Biotherapeutics
Kathryn Golden, M.S., Scientist III, Protein Production and Analytical Development, Eleven Biotherapeutics
Process and Technology Development for the Production of
UNPUBLISHED
Non-Antibody Therapeutic Proteins in a Continuous Manner
DATA
The integration of bioprocessing steps into continuous operations is paving the future for streamlined
and flexible biopharmaceutical production. Despite such simplifications, the process, hardware, and
associated control strategies must be carefully optimized to achive overall robustness and product
quality goals. This presentation will cover these topics as applied to the development of a continuous
non-antibody protein producing process.
Timothy Johnson, Ph.D., Senior Manager, Process Development, Genzyme, a Sanofi company
Keynote Address
The Evolution of QbD Implementation in Cell Culture at
Genentech and Lessons Learned
Cell Culture Recovery & Purification
CASE STUDY
UNPUBLISHED
DATA
The expectations for cell culture process characterization have evolved over the
last decade, and integration of Quality by Design (QbD) principles is the latest example. Several
Genentech projects have applied various aspects of QbD in the last several years, and with each new
project, we’ve built upon lessons learned. The broadest QbD strategy consists of a Quality Target
Product Profile, risk assessments to determine Critical Quality Attributes (CQAs), risk assessments to
determine what process parameters to study, Design of Experiment studies to investigate parameter
effects on CQAs, a Critical Process Parameter identification tool, risk assessments related to Control
System definition, and lifecycle management. Development and use of the risk assessments and other
tools has been the most challenging aspect of applying QbD to cell culture process characterization.
At first glance, all the moving pieces that are part of QbD can appear quite complex, both to
people within the company and to Health Authorities. While it is complex, one main benefit is that
it has provided a structured approach to document rationale for how we execute and interpret our
characterization studies. As we’ve become more experienced with QbD, our study designs and tools
have evolved. This talk will review the evolution of tools and studies, and discuss lessons learned in
applying QbD.
Steven Meier, Ph.D., Principal Engineer, Senior Group Leader, Genentech, Inc.
9:45 Networking Refreshment Break
10:15 Thought Leadership Forum Co-Sponsored by:
Understanding Sources of Process Variability
Chairperson’s Opening Remarks
Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden
Optimization of Process Steps during Scale Up to Reduce
CASE STUDY
UNPUBLISHED
Unanticipated Sources of Process Variability
DATA
We had developed a three step Phase 1 mAb process using typical anion and cation
exchangers (Sepharose Fast Flow). Anticipated commercial demand stimulated the development
of a modified upstream process yielding a doubling in harvest titer. Fixed tankage limitations in the
intended commercial facility stimulated the use of high capacity ion exchangers and a modification
in the flow of the process streams which resulted in a doubling of the process throughput. The new
resins were used in both the normal titer and doubled titer processes during scale-up and yielded
equivalent product quality and process performance in both process versions.
Joseph P. Martin Jr., Ph.D., Research Fellow,
Senior Scientist, Downstream Operations, Pfizer Inc.
Identification of Chromatogram Variances and
CASE STUDY
UNPUBLISHED
Their Relation to Product Quality and Process Performance
DATA
Chromatogram monitoring and trending has become a routine and powerful
tool to ensure consistent performance of liquid chromatography columns and quality of the final
product. Trending of chromatograms against a Gold Standard was implemented for both clinical
and commercial manufacturing processes at HGS to ensure downstream purification processes
are performing as expected. Several case studies will be presented to demonstrate chromatogram
variances and their potential impacts on product quality and process performance. Process
monitoring and its follow up investigations proved to be extremely valuable for better process
understanding and continuous improvement of the downstream purification processes. Several
lessons learnt, in the execution of these studies, will be presented.
Yaling Wu, Ph.D., Senior Scientist, Human Genome Sciences, Inc.
Mitigation of Chromatography Adsorbent Lot Variability
CASE STUDY
UNPUBLISHED
Through Design Space and Process Control
DATA
Lot to lot variability in chromatography adsorbent properties can result in
unacceptable performance, in both product quality and process consistency. The column operating
conditions may need to be designed to be adsorbent lot specific to achieve acceptable and consistent
performance. In this presentation, we discuss how a design space strategy can be used to mitigate
such risks for an anion exchange chromatography step, by providing additional flexibility in applying
the appropriate column operating conditions for different chromatography adsorbent lots.
Ionela Iliescu, M.S., Scientist I, Technical Development, Biogen Idec
Structuring Process Knowledge to Achieve Robust Processes, Simplified Technology Transfer and Regulatory Compliance (See more details on p.21)
19 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI