Lyophilization Of Biopharmaceuticals
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Author |
: Henry R. Costantino |
Publisher |
: Springer Science & Business Media |
Total Pages |
: 726 |
Release |
: 2005-12-05 |
ISBN-10 |
: 0971176760 |
ISBN-13 |
: 9780971176768 |
Rating |
: 4/5 (60 Downloads) |
Synopsis Lyophilization of Biopharmaceuticals by : Henry R. Costantino
Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand years. This comprehensive volume, intended for scientists in both academia and industry, covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state.
Author |
: Felix Franks |
Publisher |
: Royal Society of Chemistry |
Total Pages |
: 220 |
Release |
: 2008 |
ISBN-10 |
: 9780854041510 |
ISBN-13 |
: 0854041516 |
Rating |
: 4/5 (10 Downloads) |
Synopsis Freeze-drying of Pharmaceuticals and Biopharmaceuticals by : Felix Franks
Aimed at product and process developers in the biopharmaceutical industry and academia, this is the first book to describe freeze-drying, as related to the pharmaceutical industry.
Author |
: Louis Rey |
Publisher |
: CRC Press |
Total Pages |
: 504 |
Release |
: 1999 |
ISBN-10 |
: UOM:39015042470230 |
ISBN-13 |
: |
Rating |
: 4/5 (30 Downloads) |
Synopsis Freeze-drying/lyophilization of Pharmaceutical and Biological Products by : Louis Rey
Highlights the application of freeze-drying to pharmaceuticals-illustrating practical & industry-tested methods of preserving & reactivating delicate biologicals & biochemicals. Discusses the basic principles & engineering aspects of lyophilization, & also the role of bulking agents, additives, cryoprotectants, antioxidants, free radicals, & other products that protect the biological integrity of active substances during freezing, drying, & storage.
Author |
: Kevin R. Ward |
Publisher |
: Humana Press |
Total Pages |
: 437 |
Release |
: 2018-12-13 |
ISBN-10 |
: 1493989278 |
ISBN-13 |
: 9781493989270 |
Rating |
: 4/5 (78 Downloads) |
Synopsis Lyophilization of Pharmaceuticals and Biologicals by : Kevin R. Ward
This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab. Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.
Author |
: Feroz Jameel |
Publisher |
: Springer Nature |
Total Pages |
: 621 |
Release |
: 2023-04-24 |
ISBN-10 |
: 9783031126345 |
ISBN-13 |
: 3031126343 |
Rating |
: 4/5 (45 Downloads) |
Synopsis Principles and Practices of Lyophilization in Product Development and Manufacturing by : Feroz Jameel
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.
Author |
: Dushyant Varshney |
Publisher |
: Springer |
Total Pages |
: 399 |
Release |
: 2015-05-19 |
ISBN-10 |
: 9781493923830 |
ISBN-13 |
: 1493923838 |
Rating |
: 4/5 (30 Downloads) |
Synopsis Lyophilized Biologics and Vaccines by : Dushyant Varshney
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 |
: Satoshi Ohtake |
Publisher |
: John Wiley & Sons |
Total Pages |
: 394 |
Release |
: 2020-06-02 |
ISBN-10 |
: 9783527341122 |
ISBN-13 |
: 3527341129 |
Rating |
: 4/5 (22 Downloads) |
Synopsis Drying Technologies for Biotechnology and Pharmaceutical Applications by : Satoshi Ohtake
A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.
Author |
: Feroz Jameel |
Publisher |
: John Wiley & Sons |
Total Pages |
: 986 |
Release |
: 2010-07-13 |
ISBN-10 |
: 9780470595879 |
ISBN-13 |
: 0470595876 |
Rating |
: 4/5 (79 Downloads) |
Synopsis Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by : Feroz Jameel
A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.
Author |
: Nicole Härdter |
Publisher |
: |
Total Pages |
: 0 |
Release |
: 2024 |
ISBN-10 |
: OCLC:1424559120 |
ISBN-13 |
: |
Rating |
: 4/5 (20 Downloads) |
Synopsis The Use of Novel Polymeric Vials for Lyophilization of Biopharmaceuticals and Microwave-assisted Freeze-drying by : Nicole Härdter
Author |
: Maja Bjelošević |
Publisher |
: |
Total Pages |
: 221 |
Release |
: 2021 |
ISBN-10 |
: OCLC:1288077018 |
ISBN-13 |
: |
Rating |
: 4/5 (18 Downloads) |
Synopsis Development and optimization of lyophilization process of biopharmaceuticals by : Maja Bjelošević