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冻结乾燥会议 - Day 2
概要 |
Day 1 |
Day 2 |
Day 3
议程 (PDF : English)
DAY TWO
Thursday, January 10, 2008
7:00 Registration Open
7:30 Morning Coffee
8:15
Chairperson乫s Welcome and Opening Comments
| 8:30
Regulatory and Compliance Issues:
Being Prepared for FDA Inspections |
 |
Robert Darius, Director, Global Quality Assurance,
GlaxoSmithKline Biologicals (North America) |
- Understand
the general injectable product
requirements applicable in the
US
- Demonstrate
that your product meets the
applicable standards
- Prepare
for an FDA inspection: When is
FDA most likely to inspect? What
does the FDA consider to be red
flags? How should you
communicate with the FDA before,
during and after an inspection?
- Discuss
issues raised in FDA complete
response letters and 483
inspection observations: Learn
how to channel this information
in order to improve your
processes and increase the speed
of regulatory approvals
|
| 9:15
Specifying a Production Lyophilizer: What do I need? |
 |
Maury J. Mossman, Senior Engineer, Process Development
Engineering, Genentech, Inc. |
Selection
and specifying a production scale
lyophilizer can be a difficult
process. Many questions regarding
chamber/condenser design, loading,
CIP/SIP, refrigeration, space
availability, automation, and
documentation must be answered to
meet GMP requirements and satisfy
your manufacturing culture. This
presentation will aid you in
identifying key topics for
discussion within your company,
engaging potential vendors,
interpreting proposals, and
organizing your specifications into
a robust solicitation package.
- Learn how to progress from
high level specifications to
detailed specifications
organized by subsystem
- Understand the options
available for vessel designs,
CIP/SIP, refrigeration,
automation platforms, and more
- Identify materials,
fabrication methods, and
engineering details that affect
manufacturing and maintenance
culture
- Learn how to handle quotes,
bid packages, submittals, and
compare like-to like during
vendor selection
|
| 9:45
Case
Study: Tech Transfer of a Lyo
Product |
| Clea
Talley, Senior Engineer, DPDD Drug
Product Team Leader, Amgen |
|
10:15 Coffee Break in the Exhibit Hall
| 11:15
PAT Applications of Manometric
Temperature Measurement for
Freeze-Drying Cycle Development,
Optimization and In-Process
Monitoring / Control |
 |
Charlie Tang, Ph.D., Sr. Research Scientist, Formulation
Development, Centocor, Inc. (J&J) |
| Manometric
Temperature Measurement (MTM)yields
data of product temperature and dry
cake resistance in primary drying.
MTM measurements can be applied to
select the optimum shelf
temperature, to determine drying end
points and to evaluate residual
moisture content in secondary drying
in real-time. The freeze dryer
overload conditions can be estimated
by calculation of heat/mass flow at
the target product temperature.
Therefore, MTM can serve as a
powerful Process Analytical
Technology for freeze-drying at
laboratory and manufacturing scales.
|
| 11:45
Factory Acceptance Testing and Future Validation |
| Narlin Beaty, Ph.D., Managing Partner, Mechanical Engineering,
Qualification Process Solutions, LLC |
|
A successful FAT
and subsequent validation are all
about meeting expectations. The
vendor must be apprised of his role
by the User Requirements
Specification. The customer should
show up with a specific plan and
know that the means to get it done
are available. The customer must
understand the machine design. At
the conclusion of an FAT it is
possible to have nearly completed
the IQ and to have assured the
success of an OQ, but only if the
lyophilization vendor has been
primed to pass the test.
This presentation
gets to the heart of lyo validation
with more detail than most half day
sessions. After this session, the
participant will be able to plan and
conduct a FAT.
- How to assemble IQ paperwork
- What to ask for
- The P&ID - as planned
and as built
- A FAT plan
- Q Functional Tests - Why
each one matters
|
|
12:30 Lunch on Own or Luncheon and Strategic Solutions Presentations
1:45 Chairperson乫s Remarks
| 1:50
Foam Drying: Freeze Drying Done Under Cake Collapse Conditions? |
 |
Vu L. Truong, Ph.D., Vice President, R&D, Aridis
Pharmaceuticals |
|
Using
freeze dryers to dry
biopharmaceuticals into foamy cake
structures (i.e. foam drying) is a
half-century old drying process that
has long been dismissed as
unconventional and nothing more than
a poorly designed freeze drying
process. However, the recent
understandings of the interplay
among drying processes, solid state
properties, and formulation
parameters have enhanced our
understanding of this unique drying
process and its potential usefulness
in drying and stabilizing
biopharmaceuticals. This talk will
review the foam drying processes
landscape.
- Learn
technical details of the foam
drying process and how it
compares to conventional
lyophilization
- Learn
the impact of process parameters
on solid state properties and
how they impact product
performance
- Evaluate
the commercial usefulness of
foam drying biopharmaceuticals
|
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| 2:20
Containing and Protecting Potent
Compounds in a "Closed"
System |
 |
Joseph
Brendle, Global Product Manager, W.
L. Gore & Associates, Inc. |
| Many
of the therapeutic products in today乫s
pipeline are becoming more potent.
One implication of these highly
active products is increased costs
for facilities, capital equipment,
and cleaning and validation. These
costs have led to an increasing
interest in the implementation of
single-use components in the
manufacturing process, which can
help reduce these costs. The
freeze-drying process has its own
unique challenges with regard to
handling these highly active
products. The processing of these
products must normally be done in
open systems in order to allow the
transport of water vapor from the
product to the ice condenser.
Because the systems are open, the
product faces both a risk of
microbial and particulate
contamination, as well as the
product potentially contaminating
equipment and the environment. This
presentation will discuss single-use
technology available to provide
containment of freeze-dried product,
while allowing the transport of
solvent vapor from the frozen
product, providing a balance between
aseptic processing needs and product
containment needs. |
| 2:50
Case Study: Lyophilization of an Antibody Conjugate |
 |
Palani Palaniappan, Ph.D., Senior Director, Pharmaceutical
Sciences, Millennium Pharmaceuticals |
| Lyophilized
drug product of an antibody
conjugate will be described. Details
of the presentation will include
pre-formulation, formulation
screening and lyocycle development.
Stability evaluations of the
prototypes will be described and
recommendations for storage and
expiry will be presented. |
| 3:20
Stabilization of Proteins by Supercritical Fluid
Drying |
 |
Dr. Wim Jiskoot, Professor of Drug Delivery Technology, Leiden University |
| Among the several drying techniques available, supercritical fluid (SCF) drying is especially attractive for reasons of mild process conditions, cost-effectiveness, capability of producing microparticulate protein powders and feasibility of scaling-up. In this presentation I will explain the potential of SCF processing for the drying of formulated proteins from aqueous solutions, using myoglobin and human serum IgG as model proteins. Moreover, I will discuss ways to optimize the formulation and the processing conditions. |
|
3:35 Refreshment Break in the Exhibit Hall
|
Two-Part Case Study Presentation
|
| 4:30
Developing a Scientifically Sound Formulation and Optimizing the Lyophilization Process |
 |
J. Jeff Schwegman, Ph.D., Founder/Chief Scientific Officer,
BioConvergence LLC |
|
Due to the short
life of a patent for a new molecular
entity (NME), it is in a company乫s
best interest financially, to reduce
the time it takes to complete
formulation lyophilization cycle
development/optimization studies,
allowing them to get their products
to market sooner. Understanding and
applying the latest techniques in
these areas of development, makes
this process more efficient, and
helps to ensure that the products
will be stable over the labeled
shelf life.
- Characterization of the
biomolecule physical structure
- Determining optimal pH and
tonicity conditions for adequate
solubility and stability
establishing a stability profile
- Theory of biomolecule physical
structure stabilization
- Role of excipients in
formulation development
- Balancing act between the
thermal properties of a
formulation and added
stabilizing excipients
- Prediction of long term
stability using infrared
spectrometry
- Use of accelerated stability
studies in formulation
development
- Conducting and interpreting a
thermal analysis study
- Designing an optimized
freezing protocol
- Designing an optimized primary
and secondary drying protocol
- Characterizing the final
lyophilized product
|
|
| 5:30
Selection and Validation of Container/Closure Systems for Lyophilized Proteins |
 |
Ed White, Equipment Validation Manager, Senior Validation Scientist, Baxter BioScience |
This session will be a combination of practical examples and theory defining the theory and practice of selection and validation of a new container/closure system for a lyophilized process. Items covered will include: USP/EP testing, extractables / leachables testing, container/closure integrity, moisture vapor transmission, and sterilization methods. We will give practical examples of introduction of lyophilization closures and closures for liquid products, and give practical examples of validation of container/closure systems for lyophilized products.
- USP/EP testing
- Extractables/leachables testing
- Container/closure integrity
- Moisture vapor transmission
- Sterilization methods
|
6:00 - 7:00 pm Reception in the Exhibit Hall
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