Holdings: Lyophilized Biologics and Vaccines

Lyophilized Biologics and Vaccines: Modality-Based Approaches

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Bibliographic Details
Format:	Electronic eBook
Language:	English
Published:	New York, NY [u.a.] Springer 2015
Subjects:	Medicine Monoclonal antibodies Vaccines Pharmaceutical technology Biomedicine Vaccine Antibodies Pharmaceutical Sciences/Technology Medizin
Online Access:	TUM01 UBT01 Volltext Inhaltsverzeichnis Abstract
Physical Description:	1 Online-Ressource (XI, 401 p. 99 illus., 68 illus. in color)
ISBN:	9781493923830
DOI:	10.1007/978-1-4939-2383-0

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adam_text	LYOPHILIZED BIOLOGICS AND VACCINES / : 2015 TABLE OF CONTENTS / INHALTSVERZEICHNIS PREFACE PART I – LYOPHILIZATION HISTORY AND FUNDAMENTALS HISTORY OF LYOPHILIZATION HETEROGENEITY OF PROTEIN ENVIRONMENTS IN FROZEN SOLUTIONS AND IN THE DRIED STATE ADVANCE UNDERSTANDING OF BUFFER BEHAVIOR DURING LYOPHILIZATION ADVANCES IN INSTRUMENTAL ANALYSIS APPLIED TO THE DEVELOPMENT OF LYOPHILIZATION CYCLES NEW DEVELOPMENTS IN CONTROLLED NUCLEATION: COMMERCIALIZING VERISEQ NUCLEATION TECHNOLOGY PART II – LYOPHILIZED BIOLOGICS AND VACCINES – MODALITY CONSIDERATIONS LYOPHILIZED BIOLOGICS LYOPHILIZATION OF THERAPEUTIC PROTEINS IN VIALS - PROCESS SCALE-UP AND ADVANCES IN QUALITY BY DESIGN ADVANCES IN PROCESS ANALYTICAL TECHNOLOGY IN FREEZE DRYING PROCESS SCALE-UP AND OPTIMIZATION OF LYOPHILIZED VACCINE PRODUCTS STABILIZATION OF PLASMID DNA AND LIPID-BASED THERAPEUTICS AS DEHYDRATED FORMULATIONS PART III – ADVANCES IN ALTERNATE DRYING ALTERNATIVES TO VIAL LYOPHILIZATION SPRAY DRYING OF BIOPHARMACEUTICALS CURRENT TRENDS AND ADVANCES IN BULK CRYSTALLIZATION AND FREEZE DRYING OF BIOPHARMACEUTICALS CASE STUDIES AND EXAMPLES OF BIOPHARMACEUTICAL MODALITIES PROCESSED BY BULK CRYSTALLIZATION OR BULK FREEZE DRYING PART IV– REGULATORY, PACKAGING AND TECHNOLOGY TRANSFER CONSIDERATIONS LYOPHILIZATION OF BIOLOGICS - AN FDA PERSPECTIVE RECENT TRENDS IN LYOPHILIZED DELIVERY DEVICES AND PACKAGING LYOPHILIZATION TECHNOLOGY TRANSFER TOWARDS PRODUCT LAUNCH DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT. LYOPHILIZED BIOLOGICS AND VACCINES / : 2015 ABSTRACT / INHALTSTEXT THIS BOOK PROVIDES A DETAILED ACCOUNT OF THE MOST RECENT DEVELOPMENTS, CHALLENGES AND SOLUTIONS TO SEAMLESSLY ADVANCE AND LAUNCH LYOPHILIZED BIOLOGICS OR VACCINE PRODUCTS, BASED ON DIVERSE MODALITIES, RANGING FROM ANTIBODIES (E.G., MONOCLONAL, FUSION), COMPLEX BIOLOGICS (E.G., ANTIBODY DRUG CONJUGATES, PEGYLATED PROTEINS) AND VACCINES (E.G., RECOMBINANT PROTEIN BASED). THE AUTHORS ADEPTLY GUIDE YOU THROUGH EVERYTHING YOU NEED TO KNOW, FROM BIOPHYSICAL AND CHEMICAL STABILITY CONSIDERATIONS OF PROTEINS, TO CRITICAL ASSESSMENT DURING PROCESS SCALE-UP, TECHNOLOGY TRANSFER, PACKAGING, ALTERNATE DRYING AND DEVICE SELECTION FOR A SUCCESSFUL PROCESS VALIDATION, REGULATORY SUBMISSION AND LAUNCH OF A STABLE, SAFE AND EFFECTIVE PRODUCT.LYOPHILIZED BIOLOGICS AND VACCINES: MODALITY-BASED APPROACHES SERVES AS A REFERENCE TO ALL CRITICAL ASSESSMENTS AND STEPS FROM EARLY PRE-FORMULATION STAGES TO PRODUCT LAUNCH: PROVIDES RECENT UNDERSTANDING OF HETEROGENEITY OF PROTEIN ENVIRONMENT IN FROZEN SYSTEMS, BUFFER STABILIZATION, INSTRUMENTAL ANALYSIS AND CONTROLLED ICE NUCLEATION TECHNOLOGY DETAILS PRODUCT DEVELOPMENT STRATEGIES BASED ON DIVERSE MODALITIES OF BIOLOGICS AND VACCINES, INCLUDING PLASMID DNA AND LIPID-BASED THERAPEUTICS RECENT UPDATES ON QUALITY-BY-DESIGN AND PROCESS ANALYTICAL TECHNOLOGY APPROACHES, ILLUSTRATED BY CASE STUDIES AND FDA PERSPECTIVE PROVIDES THELATEST ACCOUNT OF ALTERNATE DRYING TECHNOLOGIES INCLUDING SPRAY DRYING AND BULK FREEZE-DRYING CHAPTERS ARE WRITTEN BY ONE OR MORE WORLD-RENOWNED LEADING AUTHORITIES FROM ACADEMIA, INDUSTRY OR REGULATORY AGENCIES,WHOSE EXPERTISE COVER LYOPHILIZATION OF THE DIVERSE MODALITIES OF BIOPHARMACEUTICALS. THEIR CONTRIBUTIONS ARE BASED ON THE EXHAUSTIVE REVIEW OF LITERATURE COUPLED WITH EXCELLENT HANDS-ON EXPERIENCES IN LABORATORY OR GMP SETUP, MAKING THIS AN EXCEPTIONAL GUIDE TO ALL STAGES OF LYOPHILIZED OR DEHYDRATED PRODUCT DEVELOPMENT AND COMMERCIAL MANUFACTURING. DUSHYANT B. VARSHNEY, PH.D., HAS MADE SIGNIFICANT CONTRIBUTIONS IN MANUFACTURING SCIENCE AND TECHNOLOGY, DUE DILIGENCE, TECH TRANSFER, PRODUCT AND PROCESS DEVELOPMENT (INCLUDING LYOPHILIZATION), QUALITY-BY-DESIGN AND PROCESS ANALYTICAL TECHNOLOGIES FOR BIOLOGICS, VACCINESAND SMALL MOLECULES. HE IS CURRENTLY A DIRECTOR OF MANUFACTURING ASSESSMENT, MS&T AT HOSPIRA INC. MANMOHAN SINGH, PH.D., IS A WELL-KNOWN EXPERT IN THE AREA OF VACCINE FORMULATIONS AND ADJUVANT RESEARCH AND HAS BEEN WORKING IN VACCINE R&D FOR THE LAST 20 YEARS.HE IS CURRENTLY THE HEAD OF GLOBAL DRUG PRODUCT DEVELOPMENT AT NOVARTIS VACCINES AND DIAGNOSTICS IN HOLLY SPRINGS, NC. DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
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discipline	Chemie / Pharmazie Biologie Medizin
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format	Electronic eBook
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indexdate	2024-07-10T07:05:25Z
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isbn	9781493923830
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physical	1 Online-Ressource (XI, 401 p. 99 illus., 68 illus. in color)
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spelling	Lyophilized Biologics and Vaccines Modality-Based Approaches Dushyant Varshney, Manmohan Singh, ed. New York, NY [u.a.] Springer 2015 1 Online-Ressource (XI, 401 p. 99 illus., 68 illus. in color) txt rdacontent c rdamedia cr rdacarrier Medicine Monoclonal antibodies Vaccines Pharmaceutical technology Biomedicine Vaccine Antibodies Pharmaceutical Sciences/Technology Medizin Varshney, Dushyant Sonstige oth Singh, Manmohan 1964- Sonstige (DE-588)142086886 oth Erscheint auch als Druckausgabe 978-1-4939-2382-3 https://doi.org/10.1007/978-1-4939-2383-0 Verlag Volltext Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028025259&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028025259&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Abstract
spellingShingle	Lyophilized Biologics and Vaccines Modality-Based Approaches Medicine Monoclonal antibodies Vaccines Pharmaceutical technology Biomedicine Vaccine Antibodies Pharmaceutical Sciences/Technology Medizin
title	Lyophilized Biologics and Vaccines Modality-Based Approaches
title_auth	Lyophilized Biologics and Vaccines Modality-Based Approaches
title_exact_search	Lyophilized Biologics and Vaccines Modality-Based Approaches
title_full	Lyophilized Biologics and Vaccines Modality-Based Approaches Dushyant Varshney, Manmohan Singh, ed.
title_fullStr	Lyophilized Biologics and Vaccines Modality-Based Approaches Dushyant Varshney, Manmohan Singh, ed.
title_full_unstemmed	Lyophilized Biologics and Vaccines Modality-Based Approaches Dushyant Varshney, Manmohan Singh, ed.
title_short	Lyophilized Biologics and Vaccines
title_sort	lyophilized biologics and vaccines modality based approaches
title_sub	Modality-Based Approaches
topic	Medicine Monoclonal antibodies Vaccines Pharmaceutical technology Biomedicine Vaccine Antibodies Pharmaceutical Sciences/Technology Medizin
topic_facet	Medicine Monoclonal antibodies Vaccines Pharmaceutical technology Biomedicine Vaccine Antibodies Pharmaceutical Sciences/Technology Medizin
url	https://doi.org/10.1007/978-1-4939-2383-0 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028025259&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028025259&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA
work_keys_str_mv	AT varshneydushyant lyophilizedbiologicsandvaccinesmodalitybasedapproaches AT singhmanmohan lyophilizedbiologicsandvaccinesmodalitybasedapproaches

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