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Sunday January 11, 2009
2:00pm – 5:00pm
SC1: How to Avoid Leachables, Extractables,
and Other Hazards in Parenteral Packaging
Strategies for ensuring the high standard for injectable drug packaging
This pre-conference short course is pre-cursor to the “Lyophilization 2009” conference
taking place on Monday, Tuesday and Wednesday and its sister conference,
“Current Trends in Dosage Form Development and Biologics Formulation: Addressing
Challenges in Stability Testing, Forced Degradation, Protein Aggregation and
Manufacturing,” taking place on Thursday and Friday. Attendees are encouraged to
attend the workshop and stay for the entire week in order to attend both events.
Topics to be covered:
- Strategies for controlling quality and minimizing risk: packaging design,
integrity, and materials
- Key considerations in primary packaging to ensure a parenteral
product’s regulatory submission
- Understanding the impact of extractables and leachables on well characterized
protein products
- Analysis, characterization and safety evaluation of extractables
and leachables
- Strategies for selection of container/closure systems
- Best practices in parenteral packaging design and testing to
ensure product integrity
- How to avoid and control extractables and leachables at
manufacturing scale
- How to avoid and control extractables and leachables from
dosing components
Course Instructor:
Michael Ruberto, Ph.D., Head of Regulatory, CIBA Expert Services
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SC2: Baculovirus for Expressing Proteins
The proven advantages of using baculovirus as a vector for expressing proteins
have been demonstrated widely and appreciated by some of the largest international
pharma companies. This course features both background on biological
properties as well as case studies from experts who use baculovirus to save time
and money producing recombinant proteins that are folded correctly and biologically
active. Learn how baculovirus can provide solutions to your organization’s
protein needs.
Topics to be covered:
- Difficult to express proteins
- Inability to transfer disease to humans
- Capacity of large cDNA inserts
- High-throughput protein production
- Automation & scaling up
Course Instructor:
Andrew Fosberry,
Research Investigator, Biological Reagents & Assay
Development, GlaxoSmithKline
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SC3: Protecting IP for Protein Therapeutics and
Diagnostics
New rulings continue to emerge from the Supreme Court of the United States that
directly impact the ways in which groups and individuals protect their Intellectual
Property (IP) in the area of protein therapeutics and diagnostics.
Topics to be Covered:
- Implications of new supreme court rulings
- Strategies for protecting IP
- Building on existing IP
Course Instructors:
Thomas J. Kowalski, Partner, Frommer Lawrence & Haug LLP
John Iwanicki, Senior Partner, Banner & Witcoff Ltd.
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SC4: Program Management for Scientists
Congratulations! You have been promoted to Program Manager. Now what? Can
your bench-top scientifi c experience in proteins - expression, characterization,biomarker discovery, development of protein-based therapeutics,
bioprocessing, etc.
- lead to success in people/business management? Most scientists train for years in
their prospective fi elds but must learn business management “on-the-fl y.” This course
is designed for scientists who have recently been promoted to program/product
manager or are planning ahead.
Topics to be covered:
- Strategic decision making
- Motivating others
- Operational planning
- Oversight of resources
- Program management models
Course Instructor:
Patricia Seymour, M.B.A., Senior Director, BioProcess Technology Consultants
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SC5: Elements of a High Quality Aseptic Filling
Program
Developing a good quality aseptic program at your facility may appear to be a
daunting enterprise. Regulations are tightening, and the ability to run an aseptic
operation in a quality manner while maintaining efficiency is often looked upon as
difficult. However, utilization of effective quality practices can actually provide anappreciable improvement in efficiency as well. This session will discuss the basic
elements of a high quality aseptic program. The discussions will include a review of
efficient batch record generation, facility disinfection, gowning, autoclaving, and
cleanroom behavior. Attendance at this seminar will inform the audience on high
quality and effective ways to perform each of the following:
- How to create good, clear batch records, and their importance to the quality process
- How to train for the gowning process
- How to train for clean room behavior
- How to efficiently sterilize disinfection tools and materials
- How to efficiently sterilize machine parts
- How to develop the zero-failure mind set
Course Instructor:
Robert J. Pallo, B.A., M.A.M., Manager, PSO Fill and Finish Operations, Allergan
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SC6: Three-Phase Partitioning: A Novel and
Scalable Protein Mini-Prep
Three-phase partitioning (TPP) is a new, exciting, and amazingly simple generic
method for extracting, purifying, and concentrating proteins. Effective with dozens
of economically important proteins, our TPP method will be illustrated in this short
course with whole, unlysed E. coli cells expressing recombinant Aequorea GFP. Within 30 minutes or less, with no affi nity tags, our TPP method removes, from
the cell-free GFP, virtually all genomic DNA, all lipids, nearly all polysaccharides,
nearly all small molecules, and as much as 99% of total absorbance at 280 nm,
leaving a crystal clear, low viscosity solution concentrated as much as 100-fold from
its original volume with GFP recoveries as high as 90%. No equipment is needed
for TPP other than simple, readily available chemicals, a low speed centrifuge, and
a spatula.
Topics to be covered:
- Protein macro-prep
- Tag-free recombinant protein purification
- Protein mini-prep
- Protein macro-prep
- Down- and Up-stream processing
Course Instructor:
William Ward, Ph.D., Associate Professor & Director, CREBB, Rutgers University, and
Founder and President, Brighter Ideas, Inc.
*Separate Registration Required
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