Cell Culture & Upstream Processing - IBC Life Sciences

Tuesday, September 23, 2008 • Main Conference (continued)
11:45 Concurrent Technology Workshops
POROS® Chromatography Media:
Transforming Your Downstream Process
The features and benefits of POROS® chromatography
media as they relate to improving downstream
purification will be discussed. Learn how POROS
media are differentiated and the benefits to downstream
purification. Process modeling will be used to highlight
potential productivity gains.
Christine Gebski, Process Applications Manager,
Applied Biosystems
Optimizing Cell Culture Data Management
and Process Control through OPC Technology
Rapidly becoming an industry standard, OPC enables realtime
data exchange between multiple vendors’ devices and
the control systems that support them. We’ll show how NBS’
new software can integrate your fermentor to metabolite
analyzers, turbidity probes, scales, or third party software.
The possibilities are endless and the advantages are clear
– optimizing process control and improving quality control in
support of PAT initiatives, with less time, effort and cost.
Richard Mirro, Product Manager,
New Brunswick Scientific
12:15 Luncheon Presentation
Economic Modeling of Single-Use Systems
The potential economic benefits of single-use systems over
traditional stainless steel systems are of increasing interest
to the bioprocessing industry. This presentation examines
modeling systems for specific applications including
liquid storage, mixing, bioreactor processing and entire
manufacturing flows. The return on investment models
shown address key areas of operational, strategic and
economic benefits. The models also provide customer-specific
guidance concerning both direct and indirect benefits.
Eric Isberg, Manager, Single-Use Process Systems,
Thermo Fisher Scientific
High Throughput Process Development: Promises, Myths, and Truths
The ultimate goal of the process development team is to stay off the critical path to drug approval. To increase the effectiveness of the development
process, many companies are turning to the use of high throughput (HT) technologies within their development platforms. In this workshop we
will describe our experience with the implementation of three such HT technologies. We have learned that there are at least four keys to successful
automation implementation, some of which could be anticipated and some of which are less obvious. Our experience will be shared.
Peggy Lio, Process Science Fellow, Invitrogen Corporation
1 Production & Economics of Biopharmaceuticals 2 Scaling Up from Bench through Commercialization
Production Planning for
Cost-Efficient Manufacture
1:45 Chairperson’s Remarks
Rhona M. O’Leary, Ph.D., Director,
BioProcess Development, Genentech, Inc.
2:00 Research in Biopharmaceutical Operations:
Advancing the State of the Art
Biopharmaceutical research has traditionally focused on drug discovery, but with a
maturing industry facing cost pressures there is increased need for pre-competitive
research into wider issues around manufacturing and logistics, an approach that
has greatly benefited other high-technology industries. We review several projects
underway at the UC Berkeley Center for Biopharmaceutical Operations, focusing
on explorations of risk and its impact across the supply chain.
Philip Kaminsky, Ph.D., Associate Professor, Department of Industrial Engineering
and Operations Research, University of California, Berkeley
Rick Johnston, Co-Director, Center for Biopharmaceutical Operations,
University of California, Berkeley
2:30 Managing Production in Light of Uncertain Demand Forecasts
During the first few years of commercial production in a new market, there can
be significant uncertainty in demand forecasts. The relationship between demand
and capacity for biologics can be very linear, so to accommodate some variability,
elasticity can be added in the form of plant utilization choices and inventory
control which can help to moderate the impact of demand swings. These
approaches will be presented.
Alison Moore, Ph.D., Vice President and Site Head, Amgen Inc.
3:00 Production Planning in Light of Uncertainty
ZymoGenetics launched a hospital-based product with entirely
outsourced manufacturing. Robust quality and supply agreements
with flexible forecasting mechanisms were critical. Close management of release
cycle times and the impact on inventory levels and response time to changes in
forecasts will be discussed. Finally, a case study of an expedited launch involving
detailed planning and coordination between various contract manufacturers and
internal resources will be presented.
Joe McKinstry, Associate Director, Production Planning & Inventory Control,
ZymoGenetics, Inc.
Regulatory Updates: Tools for QbD
(Quality by Design) Implementation
1:45 Chairperson’s Remarks
Jeffrey C. Baker, Ph.D., Senior Research Advisor, Manufacturing Sciences and
Technology, Eli Lilly and Co.
2:00 Approaches to Defining Design Space for Bioprocesses
Defining the design space for a bioprocess is an essential component of the
Quality by Design approach to product development. Pfizer has implemented a
comprehensive "Right First Time" approach to the development and commercial
manufacture of biological products. This approach includes a structured
methodology for risk assessment and experimental prioritization that facilitates
the establishment of functional relationships between process parameters and
quality attributes. This presentation will focus on implementation of this approach
for a biologic product candidate, and demonstrate possible approaches to defining
design space for bioprocesses.
Natarajan Ramasubramanyan, Ph.D., Senior Principal Scientist, Pfizer Inc
2:30 PCA/PLS Similarity Factors for
Batch-to-Batch Comparisons
This talk addresses pairwise comparison of fermentation and cell culture
batches. In early development, there may only be a few batches available, from
which performance guidelines must be set for manufacturing. Similarity factors
from PCA/PLS models can be used for comparison of batches. This technique
compares process models to look for differences in input-output relationships.
The talk will discuss the similarity factor approach and include examples using
pilot data.
Jeremy Conner, Ph.D., Senior Engineer, Amgen Inc.
3:00 Application of Multivariate Analysis (for Large Scale Data) and
DOE (at Small Scale) to Understand Key Process Inputs for a
Cell Culture Process
Multivariate analysis (MVA) of large scale data was used to study the relationships
between various offline, online, and raw material parameters. The resulting effects and
interactions were further studied via small scale studies using univariate experimentation
as well as by DOE. The raw material DOE study confirmed that interactions do exist
between various raw materials and demonstrated the value of performing comprehensive
DOE studies as part of qualification of a raw material for the process.
Sanjeev Ahuja, Ph.D., Senior Scientist, Cell Culture Process Development,
MedImmune
Concurrent with
1:45 - 3:30 Special Strategy Discussion Forum: Adopting New Technology: The Cost of Change See next page for details
Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event 7