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Stability and Characterization of Protein and Peptide Drugs

  • Kartonierter Einband
  • 376 Seiten
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This volume attemptsto provide the formulation scientist with casehistories involving the use of therapeutic proteins and peptides... Weiterlesen
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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.


This is the first volume to make available specific case histories of therapeutic proteins and peptides that have been marketed or are currently under clinical testing. The editors have selected a wide range of molecules derived from monoclonal antibodies, recombinant DNA, and natural and chemical sources to provide formulation scientists with practical examples of the deveopment of pharmaceutical products.

` A wealth of factual and illustrative material. '
Journal of Pharmacy and Pharmacology


Stability and Characterization of Human Growth Hormone; R. Pearlman, T.A. Bewley. Characterization and Formulation Considerations for Recombinantly-Derived Bovine Somatotropin; S.R. Davis, M.J. Hageman. Stability Characterization and Formulation Development of Altepase, a Recombinant Tissue Plasminogen Activator; T.H. Nguyen, C. Ward. Orthoclone OKT3; P.E. Rao, D.J. Kroon. Leuprolide and Other LHRH Analogues; A.L. Adjei, L. Hsu. Stability of Adrenocorticotropic Hormone and Pathways of Deamidation of Asparaginyl Residue in Hexapeptide Segments; K. Patel. Stability and Characterization of Human Interleikin1b; L. Gu, J. Fausnaugh. Development and ShelfLife Determination of Recombinant Interleukin2; J. Geigert, et al. Formulation and Stability of Recomibinant a1Antitrypsin; S. Vemuri, et al. Fibrolase; D. Pretzer, et al. Insulin Structure and Stability; J. Brange, L. Langkjoer. Index.


Titel: Stability and Characterization of Protein and Peptide Drugs
Untertitel: Case Histories
EAN: 9781489912381
ISBN: 148991238X
Format: Kartonierter Einband
Herausgeber: Springer US
Genre: Medizin
Anzahl Seiten: 376
Gewicht: 569g
Größe: H235mm x B155mm x T20mm
Jahr: 2013
Auflage: Softcover reprint of the original 1st ed. 1993