Pharmaceutical Formulation Development of Peptides and Proteins

Marco van de Weert

ISBN 10: 1032920653 / ISBN 13: 9781032920658

Editore: CRC Press Okt 2024, 2024

Neuware - 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. Codice articolo 9781032920658

Riassunto:

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.

Informazioni sull'autore:

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.

Dati bibliografici

Titolo: Pharmaceutical Formulation Development of ...
Casa editrice: CRC Press Okt 2024
Data di pubblicazione: 2024
Legatura: Taschenbuch
Condizione: Neu
Edizione: seconda edizione