Hovgaard / Frokjaer / van de Weert Pharmaceutical Formulation Development of Peptides and Proteins

2. New Auflage 2012
ISBN: 978-1-4398-5388-7
Verlag: Taylor & Francis Inc

Seite exportieren

Beschreibung

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product.

Providing integrated solutions, this book discusses:

The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology
The physicochemical characteristics and stability of peptides and proteins
The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids
The opportunities and challenges of non-parenteral delivery of peptides and proteins
Risk factors, specifically the development of an unwanted immune response
A simulation approach to describe the fate of peptides and proteins upon administration to a biological system
The documentation required to register a protein-based drug

Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.

Autoren

Herausgeber

Hovgaard, Lars

Frokjaer, Sven

van de Weert, Marco

Über den Autor

Hovgaard, Lars
Lars Rovgaard is Principal Scientist for NovoNordisk A/S and a Professor at Copenhagen University, Denmark.
Sven Frokjaer is Dean of the Pharmaceutical Sciences Faculty at the University of Copenhagen Denmark. Marco van de Weert is an Associate Professor of Pharmaceutics and Analytical Chemistry at the University of Copenhagen.

Inhaltsverzeichnis

Peptide SynthesisKnud J. JensenProtein ExpressionNanni DinProtein PurificationLars Hovgaard, Lars Skriver, and Sven FrokjaerCharacterization of Therapeutic Peptides and ProteinsMarco van de Weert and Tudor ArvinteChemical Pathways of Peptide and Protein DegradationTeruna J. Siahaan and Christian SchöneichPhysical Instability of Peptides and ProteinsMarco van de Weert and Theodore W. RandolphPeptide and Protein DerivativesKristian Strømgaard and Thomas Høeg-JensenPeptides and Proteins as Parenteral SolutionsMichael J. Akers and Michael R. DeFelippisPeptides and Proteins as Parenteral Suspensions: An Overview of Design, Development, and Manufacturing ConsiderationsMichael R. DeFelippis and Michael J. Akers Rational Design of Solid Protein FormulationsBingquan (Stuart) Wang and Michael J. PikalPeptide and Protein Drug Delivery Systems for Nonparenteral Routes of AdministrationUlrik Lytt Rahbek, František Hubálek, and Simon BjerregaardImmunogenicity of Therapeutic ProteinsGrzegorz Kijanka, Wim Jiskoot, Melody Sauerborn, Huub Schellekens, and Vera BrinksBiosimulation of Peptides and ProteinsTue Søeborg, Christian Hove Rasmussen, Erik Mosekilde, and Morten Colding-JørgensenRegistration of Peptides and ProteinsNiamh KinsellaIndex

Zielgruppe

Pharmaceutical scientists and material scientists working in pharmaceutical companies; chemists and cell biologists working in drug development and delivery systems and in pharmaceutical research; biopharmaceutics, graduate level students and post doctorates.

Fachgebiete