Développements récents en lyophilisation PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Développements récents en lyophilisation PDF full book. Access full book title Développements récents en lyophilisation by International Institute of Refrigeration. Download full books in PDF and EPUB format.
Author: International Institute of Refrigeration
Publisher:
ISBN:
Category : Freeze-drying
Languages : en
Pages : 228
Get Book Here
Book Description
Author: International Institute of Refrigeration
Publisher:
ISBN:
Category : Freeze-drying
Languages : en
Pages : 228
Get Book Here
Book Description
Author: International Institute of Refrigeration
Publisher:
ISBN:
Category : Freeze-drying
Languages : en
Pages :
Get Book Here
Book Description
Author: International Institute of Refrigeration
Publisher:
ISBN:
Category : Freeze-dried foods
Languages : en
Pages : 240
Get Book Here
Book Description
Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages :
Get Book Here
Book Description
First multi-year cumulation covers six years: 1965-70.
Author: Dushyant Varshney
Publisher: Springer
ISBN: 1493923838
Category : Medical
Languages : en
Pages : 399
Get Book Here
Book Description
This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It 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 and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch 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.
Author: International Institute of Refrigeration
Publisher:
ISBN:
Category : Freeze-dried foods
Languages : en
Pages : 209
Get Book Here
Book Description
Author: Louis Rey
Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 216
Get Book Here
Book Description
Author: International Institute of Refrigeration
Publisher:
ISBN:
Category : Refrigeration and refrigerating machinery
Languages : en
Pages : 306
Get Book Here
Book Description
Author: Davide Fissore
Publisher: CRC Press
ISBN: 042966401X
Category : Medical
Languages : en
Pages : 201
Get Book Here
Book Description
Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.
Author: Louis Rey
Publisher: CRC Press
ISBN: 1439825769
Category : Medical
Languages : en
Pages : 580
Get Book Here
Book Description
Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulatio
