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Addendum:
Tuesday, June 26, 2007
8:30 am - 11:30 am
Innovations in Excipient Selection for Biopharmaceutical Formulation Development Symposium
ACPE Number: #
Engineering biopharmaceutical stability is widely recognized as a key aspect of product development.
Both during storage as well as delivery, biotherapeutics have been known to undergo degradations, physical
as well as chemical. These instabilities can reduce their potency, increase the risk of adverse events
in patients, and therefore weigh in significantly on regulatory approval. One important tool that has
been employed in order to preserve the identity of the drug under consideration has been to add one
or more stabilizing excipients to the formulation. Broadly, biotherapeutic instability can be divided
into two classes – physical (such as aggregation and fragmentation), and chemical (such as oxidation
and isomerization). This symposium will feature excipient designs that prevented several aspects of
biotherapeutic instability. Excipient design proposals for biotherapeutics will be expanded to include
peptides, globular proteins, antibodies and fusion proteins. Depending on the dosage form (liquid or
lyophilized), different excipients must be considered. Recent scientific developments in choosing
excipients based on the dosage form will be included. Regulatory concerns, such as immunogenicity and
delivery device compatibility will also be addressed. Finally, proposals for stabilizing excipients
for high therapeutic concentration formulations will also be examined.
Molecular Modelling and Experimentation for Large Molecule Stabilization
Bernhardt L. Trout, Ph.D.
Massachusetts Institute of Technology
Use of DSC and XRD to characterize excipient phase transitions during freeze-drying
Raj G. Suryanarayanan, Ph.D.
University of Minnesota
The Role of Excipients in Modulating Stability of Proteins towards Aggregation
Rahul S. Rajan, Ph.D.
AMGEN, Inc.
Title to be Announced
Steve Shire, Ph.D.
Genentech
Moderators:
Tiansheng Li, Ph.D.
Amgen Inc.
Rahul S. Rajan, Ph.D.
Amgen Inc.
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