Lyophilized Biologics and Vaccines: Modality-Based Approaches
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York, NY [u.a.]
Springer
2015
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| Schlagworte: | |
| Online-Zugang: | TUM01 UBT01 Volltext Inhaltsverzeichnis Abstract |
| Beschreibung: | 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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| 245 | 1 | 0 | |a Lyophilized Biologics and Vaccines |b Modality-Based Approaches |c Dushyant Varshney, Manmohan Singh, ed. |
| 264 | 1 | |a New York, NY [u.a.] |b Springer |c 2015 | |
| 300 | |a 1 Online-Ressource (XI, 401 p. 99 illus., 68 illus. in color) | ||
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| 650 | 4 | |a Medicine | |
| 650 | 4 | |a Monoclonal antibodies | |
| 650 | 4 | |a Vaccines | |
| 650 | 4 | |a Pharmaceutical technology | |
| 650 | 4 | |a Biomedicine | |
| 650 | 4 | |a Vaccine | |
| 650 | 4 | |a Antibodies | |
| 650 | 4 | |a Pharmaceutical Sciences/Technology | |
| 650 | 4 | |a Medizin | |
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Datensatz im Suchindex
| _version_ | 1804174754594160640 |
|---|---|
| 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 |
| doi_str_mv | 10.1007/978-1-4939-2383-0 |
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| indexdate | 2024-07-10T07:05:25Z |
| institution | BVB |
| isbn | 9781493923830 |
| language | English |
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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 |
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