Protein Therapeutics

1. Front Matter

   Pages i-xiii

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2. Protein Production in Eukaryotic Cells

   • Kripa Ram, Diane Hatton, Sanjeev Ahuja, Jean Bender, Alan Hunter, Richard Turner

   Pages 1-39

3. Production of Protein Therapeutics in the Quality by Design (QbD) Paradigm

   • Anurag S. Rathore, Sumit K. Singh

   Pages 41-67

4. Characterization of Therapeutic Proteins

   • E. B. Struble, N. Kirschbaum, J. Liu, E. Marszal, M. Shapiro

   Pages 69-121

5. Immunogenicity Lessons Learned from the Clinical Development of Vatreptacog Alfa, A Recombinant Activated Factor VII Analog, in Hemophilia with Inhibitors

   • Kasper Lamberth, Karin Nana Weldingh, Silke Ehrenforth, Mette Ribel Chéhadé, Henrik Østergaard

   Pages 123-160

6. The Art of Gene Redesign and Recombinant Protein Production: Approaches and Perspectives

   • Anton A. Komar

   Pages 161-177

7. Back Matter

   Pages 179-182

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Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactionson the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors

• Bio-betters
• Bioengineering
• Biosimilars
• Factor IX-FC Fusion Protein
• Factor VIIa Analogs
• Monoclonal Antibodies
• Personalized Medicine
• Protein Therapeutics
• Quality-by-design
• Replacement Protein-therapeutics

• Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, FDA | CBER | OTAT, Federal Research Center at White Oak, Silver Spring, USA

  Zuben E. Sauna, Chava Kimchi-Sarfaty

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