This volume attemptsto provide the formulation scientist with
casehistories involving the use of therapeutic proteins and
peptides that have been mar- keted or are under clinical testing.
In previous volumes of this series,funda- mental theories and
principles ofprotein characterization and stability were presented
in depth by researchers in their fieldsofexpertise. The way from
theory to practice isnot alwaysobvious and straightforward. There
isa need for practical examples of how the principles and theories
are put into use, specificallyin the development of a
pharmaceutical product. It is our hope that this volume will
fulfillsuch a need. Itisnot asimple task to choose a panel
ofproteinsand peptides from the over 200 agents in human clinical
trials. We have tried to collect a wide representation of molecules
of different sizes-from 10 amino acids (Leu- prolide) to 1020 amino
acids (Muromonab CD3). The examples include agents derived from
various sources including monoclonal antibodies (Mur- omonab CD3),
recombinant DNA (human and bovine growth hormones), natural source
(fibrolase), and chemical synthesis (Leuprolide). Clearly this list
is not intended to be encyclopedic. It isthe first time a
collection of this sort has been made accessibleto the formulation
scientists involved in devel- oping protein and peptide products.
Although each chapter in this volume focuses primarily on the
charac- terization and stability of a specific molecule, each has
unique aspects.
General
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