Full Conference Details Inside

9:15
10:30
11:00
11:30
Enhancing Manufacturing and
Development Efficiency
Challenges of Managing Multiple Clinical and
Commercial Tech Transfers to an Existing High-Run
Rate Commercial Manufacturing Facility
Introduction of new processes into an established, high run rate
commercial manufacturing facility can pose significant logistical and
technical challenges. In addition to ensuring the success of the new
product introduction, careful consideration is required to ensure the
fidelity of the existing process is maintained and the established plant
capability and run rate is not disturbed. Simultaneous tech transfers
for multiple processes with differing levels of process and scale-up
experience add to the management complexity. This presentation will
summarize these challenges and the approaches taken to mitigate
any potential impact and maximize tech transfer success.
Gregory R. Naugle, Director, Process Development, Amgen Inc
Wednesday, October 10, 2012
9:45 Networking Refreshment Break in Poster and Exhibit Hall Sponsored by:
Product Lifecycle Planning:
Innovative Solutions to Meet Quality
and Process Challenges
10:30 Thought Leadership Forum Sponsored by:
Reducing the Risk of a Contamination Event Due to Raw Materials (See more details on p.21)
Microbial Contaminations:
The Fundamentals of Prevention
Microbial contaminations are a reality for the Biotech
industry. They are costly to an organization in many ways:
financially, lost time in production, unplanned resource
allocations, and elevated compliance risk. This presentation
and interactive discussion will focus on the basic fundamentals
to preventing opportunities for microbial ingress into process
equipment and/or processing environments. The presentation will
cover aspects related to facility design and operation, personnel,
equipment design and operation, and material/process flow. The
discussion will include a case study where data analysis was used
to identify areas where prevention measures were implemented,
resulting in a significant reduction in contamination rates.
Phil McDuff, Director, Global Engineering
and Facilities, Biogen Idec
Volume Reduction Strategies Using Single-Pass
TFF to Accommodate Higher Titers, Multi-Product
Processing, and Tank Volume Limitations
Presenter to be announced
Application of Innovative Technologies to
Develop Disruptive Continuous
Bioprocessing Platform
UNPUBLISHED
DATA
CASE STUDY
UNPUBLISHED
DATA
In the current environment of diverse product pipelines,
rapidly fluctuating market demands and growing
competition from biosimilars, biotechnology companies are
increasingly driven to develop innovative solutions for highly flexible
and cost effective manufacturing. To meet these challenging demands,
integrated continuous processing, comprised of high-density perfusion
cell culture and a directly coupled continuous capture step, can be
used as a universal biomanufacturing platform. This study highlights
the significance of using innovative technologies to develop robust,
disruptive solutions such as continuous bioprocess platform.
Veena Warikoo, Ph.D., Associate Director, Purification
Development, Genzyme, a Sanofi company
Co-authors: Rahul Godawat, Daniel Geoffrey Cummings, Sujit Jain,
Kevin Brower, Mahsa Rohani, Konstantin Konstantinov and
Frank Riske
Comparability and Biosimilarity: Two Sides of the
Same (or a Different) Coin?
Biosimilarity between a follow-on biomolecule and its innovator
counterpart relies upon many of the same principles as does the
demonstration of comparability between pre- and post-change
biotech products by an innovator company; however, there are
important differences. This presentation will address both the
similarity and the differences between the two paradigms. In
addition, the application of QbD principles to drug development
for both paradigms will be discussed.
Stephen C. Hosselet, Ph.D., Director,
Global Analytical Sciences, Amgen Inc.
Understanding the Innovator to Drive Development
of a Biosimilar
Joseph McClellan, MBA, Ph.D., Director, Bio-enhancement
Development Unit, Pfizer Inc.
Featured Presentation
Understanding FDA’s Regulation of Biosimilars
Thinking about developing a biosimilar protein product for the
US market? In February, 2012, the FDA issued draft guidance
delineating some of the regulatory expectations for biosimilars,
covering over-arching scientific considerations as well as
specific analytical, nonclinical, and clinical approaches for the
demonstration of similarity to a US-licensed reference product. This
talk will offer insights into FDA’s overall approach to the regulation
biosimilars with emphasis on the evaluation of molecular similarity.
Emily Shacter, Ph.D., Consultant, ThinkFDA, LLC; former Chief,
Laboratory of Biochemistry, Division of Therapeutic Proteins,
Office of Biotechnology Products, CDER, FDA
Post-Approval Changes of Biosimilar
Products: A Case Study
The global regulatory framework established for the
management of post-approval changes for originator
biologic products is relevant to the management of
these changes for biosimilar products. The foundation of this
regulatory framework is a well-designed comparability exercise
that compares the quality attributes of a biologic product before
and after a change. In this talk, a comparability case study for a
post-approval site and scale change for a biosimilar product will
be discussed.
Goran Valinger, Ph.D., Director, Technical Support,
Hospira Zagreb, Croatia
CASE STUDY
UNPUBLISHED
DATA
Specialty Focus Track
Mixed Mode Chromatography
Approach for Viral Clearance
Dan Bezila, M.S., Senior Associate Scientist,
API Large Molecule Development,
Janssen Research & Development, LLC
UNPUBLISHED
DATA
Risk Mitigation Strategies for Non-Enveloped Viral
Contaminants
Small, non-enveloped viruses represent a critical challenge to the
biologics industry. Recent contamination events with porcine
circovirus, vesivirus 2117 (a calicivirus), and murine minute virus
(a parvovirus) underscore the concern. The challenge is due to
the fact that these viruses are extremely resistant to physical and
chemical inactivation and consequently survive such treatments as
extremes of pH, high temperature, solvent/detergent, and gamma
irradiation that readily result in the inactivation of the more fragile
lipid-enveloped viruses. This presentation will review the clearance
that may be achieved for these viruses using a variety of procedures.
The discussion will also highlight the screening and treatment of
raw materials, facility process flow, and facility cleaning validation
studies as complementary strategies for coping with these viruses..
Jeri Ann Boose, Ph.D., Director of Biopharmaceutical Services,
Eurofins Lancaster Laboratories, Inc.
Regulatory Prospective on New Trends and
Developments
Hannelore Willkommen, Ph.D., Regulatory Affairs and
Biological Safety Consulting, Germany
Dealing with Inconsistent Results from Testing
Labs that are not Comparable – Who Do You
Trust? What Do You Do with Those Results?
What are the Regulatory Implications?
Norbert Schuelke, Ph.D., Director, Millennium Pharmaceuticals Inc.
Early Registration and Group Discounts are Available (see page 27) 12