Biobetters : Protein Engineering to Approach the Curative /

Detalles Bibliográficos
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Rosenberg, Amy. (Editor ), Demeule, Barthélemy. (Editor )
Formato: eBook
Lenguaje:English
Publicado: New York, NY : Springer New York : Imprint: Springer, 2015.
Edición:1st ed. 2015.
Colección:AAPS Advances in the Pharmaceutical Sciences Series, 19
Materias:
Tabla de Contenidos:
  • Introduction
  • Targeting glucocerebrosidase to macrophages for effective treatment of patients with Gaucher disease: setting the paradigm of a "fit for purpose" approach to enzyme replacement therapy
  • Challenges of Enzyme Replacement Therapy: Poor tissue distribution in lysosomal diseases using Pompe disease as a model
  • Muscle targeting
  • Blood-Brain Barrier Targeting of Therapeutic Lysosomal Enzymes
  • Novel Methods for Addressing Immunogenicity in Therapeutic Enzymes
  • Structure of monoclonal antibodies
  • Prediction of aggregation in vivo by studies of therapeutic proteins in human plasma
  • Effect of Hydrolytic Degradation on the In Vivo Properties of Monoclonal Antibodies
  • Oxidation of proteins in the in-vivo environment: what we know; what we need to study and potential mitigation strategies
  • Molecular assessment: balancing affinity, PK and manufacturability
  • Perspectives on engineering biobetter therapeutic proteins with greater stability in inflammatory environments
  • Antibody-like molecules designed for superior targeting and pharmacokinetics
  • Alternative protein scaffolds as novel biotherapeutics
  • Current strategies for pharmacokinetic optimization
  • Biosimilar and Biobetter Scenarios for the US and Europe: What Should We Expect?
  • Regulatory considerations for approval of biobetter products.