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Principles and Practice of the Lyophilization Process and Product Development...
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eBay item number:356810934454
Item specifics
- Condition
- Book Title
- Principles and Practice of the Lyophilization Process and Product
- ISBN
- 9783031126338
About this product
Product Identifiers
Publisher
Springer International Publishing A&G
ISBN-10
3031126335
ISBN-13
9783031126338
eBay Product ID (ePID)
26057297768
Product Key Features
Number of Pages
Xiii, 623 Pages
Publication Name
Principles and Practice of Lyophilization in Product Development and Manufacturing
Language
English
Subject
Pharmacy, Pharmacology, Chemistry / Organic
Publication Year
2023
Type
Textbook
Subject Area
Science, Medical
Series
Aaps Advances in the Pharmaceutical Sciences Ser.
Format
Hardcover
Dimensions
Item Weight
63.1 Oz
Item Length
11 in
Item Width
8.3 in
Additional Product Features
Series Volume Number
59
Number of Volumes
1 vol.
Illustrated
Yes
Table Of Content
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?.
Synopsis
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.
LC Classification Number
RS1-441
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- c***m (412)- Feedback left by buyer.Past 6 monthsVerified purchaseAAA+++; Excellent Service; Great Pricing; Fast Delivery-Faster Than Expected to Hawaii using free shipping USPS Ground Mail, Received 06/18; Paperback book in Great Condition as Described ; TLC Packaging; Excellent Seller Communication, Sends updates . Highly Recommended!, Thank you very much!
- l***1 (1487)- Feedback left by buyer.Past 6 monthsVerified purchaseGreat seller; book exactly as described in mint condition sold at a reasonable price; seller shipped item FAST, FREE and with tracking information, a must nowadays; seller shipped in tight, cardboard mailing envelope, which tightly fit over the book, preventing damage in shipment; good communication too; rate seller 10+++++Cuentos de La Habana Elegante, Brand New, Free shipping in the US (#364594098367)
- c***t (921)- Feedback left by buyer.Past 6 monthsVerified purchaseThe book I bought was reasonably priced and when it arrived it was in the 'Like New' condition specified in the listing. However, when I saw that the seller had not shipped the book after more than 15 days had passed since my order I felt I must write to say that I had actually placed an order with the seller and inquire when it planned to send the book. The brusque reply was that a tracking number was available, but no number HAD been created until I pointed out that I had placed the order.Catland by Hughes, Kathryn, Like New Used, Free shipping in the US (#356798982438)
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Seller Feedback (385,208)
- c***m (412)- Feedback left by buyer.Past 6 monthsVerified purchaseAAA+++; Excellent Service; Great Pricing; Fast Delivery-Faster Than Expected to Hawaii using free shipping USPS Ground Mail, Received 06/18; Paperback book in Great Condition as Described ; TLC Packaging; Excellent Seller Communication, Sends updates . Highly Recommended!, Thank you very much!
- l***1 (1487)- Feedback left by buyer.Past 6 monthsVerified purchaseGreat seller; book exactly as described in mint condition sold at a reasonable price; seller shipped item FAST, FREE and with tracking information, a must nowadays; seller shipped in tight, cardboard mailing envelope, which tightly fit over the book, preventing damage in shipment; good communication too; rate seller 10+++++Cuentos de La Habana Elegante, Brand New, Free shipping in the US (#364594098367)
- c***t (921)- Feedback left by buyer.Past 6 monthsVerified purchaseThe book I bought was reasonably priced and when it arrived it was in the 'Like New' condition specified in the listing. However, when I saw that the seller had not shipped the book after more than 15 days had passed since my order I felt I must write to say that I had actually placed an order with the seller and inquire when it planned to send the book. The brusque reply was that a tracking number was available, but no number HAD been created until I pointed out that I had placed the order.Catland by Hughes, Kathryn, Like New Used, Free shipping in the US (#356798982438)