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Principles and Practices of Lyophilization in Product Development and Manufacturing (Record no. 103279)

MARC details
000 -LEADER
fixed length control field 05745nam a22005055i 4500
001 - CONTROL NUMBER
control field 978-3-031-12634-5
003 - CONTROL NUMBER IDENTIFIER
control field DE-He213
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20240729135818.0
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr nn 008mamaa
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 230424s2023 sz | s |||| 0|eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9783031126345
-- 978-3-031-12634-5
072 #7 - SUBJECT CATEGORY CODE
Subject category code MQP
Source bicssc
072 #7 - SUBJECT CATEGORY CODE
Subject category code MED072000
Source bisacsh
072 #7 - SUBJECT CATEGORY CODE
Subject category code MQP
Source thema
245 10 - TITLE STATEMENT
Title Principles and Practices of Lyophilization in Product Development and Manufacturing
250 ## - EDITION
Edition statement 1st ed. 2023.
264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Place of production, publication, distribution, manufacture Cham :
Name of producer, publisher, distributor, manufacturer Springer International Publishing :
-- Imprint: Springer,
Date of production, publication, distribution, manufacture, or copyright notice 2023.
300 ## - PHYSICAL DESCRIPTION
Physical description XIII, 623 p.
Other physical details online resource.
336 ## - CONTENT TYPE
Content type term text
Content type code txt
Source rdacontent
337 ## - MEDIA TYPE
Media type term computer
Media type code c
Source rdamedia
338 ## - CARRIER TYPE
Carrier type term online resource
Carrier type code cr
Source rdacarrier
490 1# - SERIES TITLE
Series statement AAPS Advances in the Pharmaceutical Sciences Series,
International Standard Serial Number 2210-738X ;
Volume 59
505 0# - CONTENTS
Contents Overview of Freeze Drying -- Characterization and Determination of Freeze Drying Properties of Frozen Formulations - Case Studies -- Beyond pH: Acid/base relationships in frozen and freeze-dried pharmaceuticals -- Concepts and Strategies in the Design of Formulation for Freeze Drying -- Formulation Design for Freeze Drying - Case studies of Stabilization of Proteins -- Challenges and Considerations in the Development of a High Protein Concentration Lyophilized Drug Product -- Freeze-drying of thermosensible pharmaceuticals with organic co-solvent + water formulations -- Primary container closure system selection for lyophilized drug products -- Vial Breakage During Lyophilization -- The Nucleation of Ice -- Stresses, Stabilization, and Recent Insights in Freezing of Biologics -- Lyophilization Process Understanding and Scale-up using ab initio Vial Heat Transfer Modeling -- Secondary drying: Challenges and Considerations -- Design and Process Considerationsin Spray Freeze Drying -- LyoPRONTO: Deterministic and Probabilistic Modeling. Tutorial and Case Study -- Utilizing Solid-State NMR Spectroscopy to Assess Properties of Lyophilized Formulations -- Design of Moisture Studies for a Lyophilized Product -- Laser-Based Headspace Moisture Analysis for Rapid Nondestructive Moisture Determination of Lyophilized Products -- Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process -- Process Analytical Technology (PAT) for Lyophilization Process Monitoring and End Point Detection -- Advances in Process Analytical Technology - A Small Scale Freeze-Dryer for Process Analysis, Optimization, and Transfer -- Overview of Heat and Mass Transfer Modeling in Lyophilization to Create Design Spaces and Improve Process Analytical Tool (PAT) Capability -- Application of QbD elements in the Development and Manufacturing of a Lyophilized product -- Characterization of Freeze Dryer -- Scale-up and Technology Transfer of a Lyophilization Process -- Lyophilization Validation: Process Design and Modeling -- Lyophilization Validation: Process Qualification and Continued Process Verification -- Homogeneity Assessment of Lyohilized Biological Drug Products During Process Performance Qualification -- Informed Manufacturing through the use of Big Data Analytics for Freeze Drying Process & Equipment -- Multivariate Analysis for Process Understanding, Continuous Process Verification and Condition Monitoring of Lyophilization Processes -- Lyophilized Drug Product Cake Appearance: What Is Acceptable?.
520 ## - ABSTRACT
Abstract The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing, starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, Principles and Practice of Lyophilization Process and Product Development contains an entire dedicated section on "Preservation of Biologicals" comprised of nine chapters written by experts and including case studies.
650 #0 - SUBJECT HEADINGS
Subject term Pharmacy.
650 #0 - SUBJECT HEADINGS
Subject term Pharmaceutical chemistry.
650 #0 - SUBJECT HEADINGS
Subject term Pharmacology.
9 (RLIN) 7400
650 #0 - SUBJECT HEADINGS
Subject term Medicine
General subdivision Research.
650 #0 - SUBJECT HEADINGS
Subject term Biology
General subdivision Research.
650 14 - SUBJECT HEADINGS
Subject term Pharmacy.
650 24 - SUBJECT HEADINGS
Subject term Pharmaceutics.
650 24 - SUBJECT HEADINGS
Subject term Pharmacology.
9 (RLIN) 7400
650 24 - SUBJECT HEADINGS
Subject term Biomedical Research.
700 1# - ADDED PERSONAL NAME
Added personal author Jameel, Feroz.
Relator term editor.
710 2# - ADDED CORPORATE NAME
Added corporate author SpringerLink (Online service)
830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE
Uniform title AAPS Advances in the Pharmaceutical Sciences Series,
International Standard Serial Number 2210-738X ;
Volume number/sequential designation 59
856 ## - ONLINE RESOURCE
Uniform Resource Identifier <a href="#gotoholdings">#gotoholdings</a>
Link text Access resource
245 ## - TITLE STATEMENT
Medium [E-Book]
347 ## - DIGITAL FILE CHARACTERISTICS
File type text file
Encoding format PDF
Source rda
912 ## -
-- ZDB-2-SBL
912 ## -
-- ZDB-2-SXB
Holdings
Withdrawn status Lost status Damaged status Not for loan Home library Current library Shelving location Date acquired Source of acquisition Total Checkouts Date last seen Uniform Resource Identifier Price effective from Koha item type
        Hillingdon Hospitals Library Services (Hillingdon Hospitals NHS Foundation) Hillingdon Hospitals Library Services (Hillingdon Hospitals NHS Foundation) Online 02/05/2024 Springer BiomedLifeSc_2023   02/05/2024 https://go.openathens.net/redirector/nhs?url=https://doi.org/10.1007/978-3-031-12634-5 02/05/2024 Electronic book
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