Full Conference Details Inside

10:15
10:45
11:15
Enhancing Manufacturing
and Development Efficiency
Single Use and Simplicity – Three Years
in at Shire HGT
Paul Slaman, Associate Director, Manufacturing
Technical Services, Shire Human Genetic Therapies
Cleaning Validation Challenges
for Bioprocesses: Leveraging
Cleaning Characterization to
Streamline New Product Launches
Tuesday, October 9, 2012
CASE STUDY
UNPUBLISHED
DATA
Strategies for addressing cleaning validation
challenges for bioprocesses will be presented. The
strategies are rooted in systematic and proactive
approaches to cleaning. Several approaches, including
performing small-scale cleanability studies to minimize
at-scale cleaning validation studies, the use of master
soils to streamline and provide flexibility for scheduling
cleaning validation activities, and leveraging inactivation
studies to obviate the need for product-specific assays
and MAC assessments, will be discussed.
Rizwan Sharnez Ph.D., Principal Engineer,
Process Engineering, Amgen Inc.
Co-authors: Michelle Monk, Laura Klewer,
Chris Flint, Arun Tholudur Ph.D., Amgen Inc.
Optimizing Changeover in a Large
Scale Multi Product Bioprocess Plant
MedImmune’s Manufacturing Center in Frederick,
Maryland recently transitioned from a steady,
single product facility to a fast-paced, clinical/
commercial multiproduct facility. Senior
leadership challenged the site to optimize change
over from its early cycle time of 28 days to 14 days
or less. Join us to review the cross-functional work
and operational excellence tools that successfully
drove change over optimization.
Chad Briggs, Senior Manufacturing Manager,
MedImmune
Product Lifecycle Planning:
Innovative Solutions to Meet
Quality and Process Challenges
Life Cycle Management - A Case
Study Using a Novel Protein
Eli Lilly has built, qualified and validated a new
state of the art facility in Kinsale, Ireland. The
subject of this presentation is a novel protein that
was the first molecule validated in this facility. The
talk will highlight the approach taken to incorporate
the new FDA guidance document and current
European perspectives and the business drivers of
global supply chain on process validation, the quality
systems for lifecycle management and discuss the
approach being taken for continuous verification.
Graham McCartney, Ph.D., Technical Services Lead
Biotechnology, Eli Lilly S.A., Ireland
Considerations and Challenges
when Evaluating Vials and
Stoppers as Part of Parenteral
Product Container Closure System
Selecting vial and stopper combinations
with optimal fit can be challenging. Issues during
manufacturing can negatively impact process
productivity and timelines, and proper closure
integrity is of utmost importance. Data will be
shown which demonstrates such challenges and
recommendations will be made on how to evaluate
material attributes and dimensions in order to
implement proper control strategies.
Melissa D. Perkins, Ph.D., Senior Director,
Drug Product Sciences, Human Genome Sciences, Inc.
Strategies for Continued Process
Verification – A Lifecycle Approach
to Quality by Design (QbD) and
Process Validation
CASE STUDY
CASE STUDY
UNPUBLISHED
DATA
CASE STUDY
UNPUBLISHED
DATA
As per the new FDA process validation guidance, the
third validation stage describes a lifecycle approach to
continually assure that the process remains in a state
of control (the validated state) during commercial
manufacture. This presentation will describe strategies
and approaches to implementing a continuous
monitoring and continuous improvement program
consistent with QbD principles applied to earlier stages
such as process design.
Kumar Dhanasekharan, Ph.D., Associate
Director, Process Sciences and Technology,
Genzyme, a Sanofi company
Analytical Technologies
for Biopharmaceutical
Development
Developing an Extractable/
Leachable Program
E&L studies are a required part of license
pplications, but can be challenging for biotech
companies due to lack of infrastructure and
experience. In addition to testing of container
closure materials, the evaluation process at HGS
included a risk assessment for contact materials of
the manufacturing and filling processes to determine
which additional components required testing.
Studies were performed utilizing a combination of
external services and a buildup of internal capabilities.
Helmut Schneider, Ph.D., Principal Scientist,
Analytical Sciences, Human Genome Sciences, Inc.
CASE STUDY
Automated Analytics, Data
Reduction, and Data Management
In order to meet the demands of high sample
numbers and large amounts of data in short
periods of time produced in the Automated
Analytical laboratories, we have developed, and
are evolving, a work stream for sample submission
and tracking, analytical quality, and data
management that requires less "hand-on" time to
allow analysts to focus more time in the labs.
Kristine M. Kearns, Senior Research Biochemist,
Vaccine Analytical Development,
Merck and Co., Inc.
Preliminary Characterization
of a Novel Class of Multi-Specific,
Multi-Valent Therapeutic
Zybodies are a novel class of multi-specific
antibodies that consist of short molecular
recognition domains fused to the termini
of mAbs. The presentation will discuss the
expected attributes and behavior of Zybodies,
the analytical approaches and challenges used
to monitor them, along with a comparison to
mAbs and other bispecific molecules.
Rajesh Krishnamurthy, Ph.D., Director,
Pharmaceutical Development, Zyngenia, Inc.
Antibody Drug Conjugate
Development & Production
Antibody Drug Conjugate Process
Development Considerations
Mark Itterman, Senior Manager, Process
Development, Millennium Pharmaceuticals, Inc.
Approaches to Improve Efficiency
and Speed to the Clinic for Antibody
Drug Conjugates
John Moscariello, Ph.D., Principal Scientist,
Purification Process Development, Amgen Inc.
Regulatory Considerations for the
Manufacture, Characterization and
Quality Assurance of Antibody-Drug
Conjugates
Since the first IND for an antibody-drug conjugate
(ADC) was submitted almost 20 years ago,
only two ADCs have been approved; Mylotarg
in 2000 and Adcetris 2011. During that time,
improvements in the conjugation chemistry result
in ADCs with improved serum stability. New and
improved analytical methods allow a more precise
characterization of the ADC. This presentation
will focus the regulatory approach to ADCs from
the drug and biologics review perspectives.
Marjorie A. Shapiro, Ph.D., Chief, Laboratory
of Molecular and Developmental Immunology,
Division of Monoclonal Antibodies, US FDA
11:45 Concurrent Technology Workshops
What’s Next in
Meeting Marketplace
Single-Use Vs.
Early Process Development
Fed-Batch Cell Culture?
Needs - Rapid
Multi-Use Equipment:
Integrating Chemically
The history of fed-batch as a method of producing Development of Robust
An Environmental Life Cycle Assessment Defined Supplements and Feeds
proteins in CHO cells is remarkable with respect to
the progress made in a relatively short period of time.
Within the past decade we have progressed from
IgG titers in the milligram per liter range to current
routine yields of multiple grams per liter. The latter
have been achieved by both sophisticated feeding
strategies and cell line engineering. This workshop
will provide data related to recent improvements in
the various elements that impact fed-batch culture
and how one can maintain flexibility in scale-up
Peggy Lio, Senior Process Science Fellow, Gibco®
PD-Direct Bioprocess Services, Life Technologies
Manufacturing Processes
As the biopharmaceutical industry matures,
outsourcing has become an integral part of production
strategies including a shift towards the outsourcing
of research and process development activities. For
contract manufacturing organizations, innovation and
providing custom solutions has become ever more
important. We will outline aspects of our current
process and analytical development activities to meet
the needs of the biomanufacturing market.
Greg Adams, Ph.D., Section Leader, Analytical
Development, Fujifilm Diosynth Biotechnologies
of an Entire mAb Production Process
This cradle-to-grave environmental study compares
single-use vs. traditional process equipment for
the production of monoclonal antibodies at 100L,
500L and 2000L scales. The study results show
that, for the conditions explored in this study,
the single-use process technology exhibits lower
environmental impact by reducing or eliminating
the need for large quantities of steam, process
water, and water for injection.
Jeffrey Carter, Ph.D., Director of Research &
Development, GE Healthcare Life Sciences
Elizabeth C. Dodson, Ph.D., Advanced
Bioprocessing, BD Biosciences
12:15 Luncheon Presentation
“Open Sourcing” – Increasing Options to Meet the Challenges of Drug Development and Manufacturing
Developing and implementing a manufacturing process for clinical scale material involves many steps, requiring knowledge, expertise and resources. In this presentation we introduce the concept
of “Open-Sourcing,” an alternative view of how such knowledge, expertise and resources can be accessed and delivered to speed the journey to the clinic. This presentation will highlight through a
case study how a solutions-based approach enabled the development of a clinical manufacturing process for a new drug in parallel with the construction of a new clinical manufacturing facility.
Richard Pearce, Director of Strategy Development, BioPharm Process Solutions, EMD Millipore
Sponsored by:
9 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI