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Biobetters = Protein Engineering to Approach the Curative /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Biobetters/ edited by Amy Rosenberg, Barthélemy Demeule.
其他題名:	Protein Engineering to Approach the Curative /
其他作者:	Rosenberg, Amy.
面頁冊數:	XV, 378 p. 50 illus., 22 illus. in color.online resource. :
Contained By:	Springer Nature eBook
標題:	Pharmaceutical technology. -
電子資源:	https://doi.org/10.1007/978-1-4939-2543-8
ISBN:	9781493925438

Biobetters = Protein Engineering to Approach the Curative /
BiobettersProtein Engineering to Approach the Curative /[electronic resource] :edited by Amy Rosenberg, Barthélemy Demeule. - 1st ed. 2015. - XV, 378 p. 50 illus., 22 illus. in color.online resource. - AAPS Advances in the Pharmaceutical Sciences Series,192210-7371 ;. - AAPS Advances in the Pharmaceutical Sciences Series,20.

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.

Over the last few decades, biopharmaceuticals have transformed many areas of healthcare and have given hope and extended the lives of many patients. Curative treatments, however, remain elusive in most cases. This book describes strategies to develop improved versions of biopharmaceuticals (“biobetters”) to bridge the gap between existing therapies and curative therapies. With an aim to stimulate research and development in a wide array of therapeutic areas, diverse topics are covered, including the following: tissue specific targeting of enzyme replacement therapies; the development of novel protein structures with the potential to improve upon critical attributes of current monoclonal antibodies; the modification of current monoclonal antibody designs to improve their in vivo stability; and finally, the economic and regulatory considerations for the development of biobetters.

ISBN: 9781493925438

Standard No.: 10.1007/978-1-4939-2543-8doiSubjects--Topical Terms:

557391
Pharmaceutical technology.

LC Class. No.: RS380

Dewey Class. No.: 615.19

Biobetters = Protein Engineering to Approach the Curative /
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505 0 $a 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.
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