Principles And Practices Of Lyophilization In Product Development And Manufacturing
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Principles And Practices Of Lyophilization In Product Development And Manufacturing
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Author : Feroz Jameel
language : en
Publisher: Springer Nature
Release Date : 2023-04-24
Principles And Practices Of Lyophilization In Product Development And Manufacturing written by Feroz Jameel and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-04-24 with Medical categories.
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.
Sterile Product Development
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Author : Parag Kolhe
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-10-12
Sterile Product Development written by Parag Kolhe and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-12 with Medical categories.
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
Nanotechnological Advances In Environmental Cyber And Cbrn Security
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Author : Plamen Petkov
language : en
Publisher: Springer Nature
Release Date : 2025-08-25
Nanotechnological Advances In Environmental Cyber And Cbrn Security written by Plamen Petkov and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-08-25 with Technology & Engineering categories.
This book is based on the lectures and contributions from the NATO Advanced Study Institute on 'Nanotechnological Advances in Environmental, Cyber, and CBRN Security,' held in Sozopol, Bulgaria, in September 2024. It provides a comprehensive overview of the field, incorporating articles that address the preparation and characterization of various nanoscale materials, including metals, oxides, glasses, polymers, and carbon-based materials. Additionally, the book includes contributions on the applications of these materials in diverse security and safety-related fields. The book adopts an interdisciplinary approach, drawing on the expertise of authors from physics, chemistry, engineering, materials science, and biology. A notable feature is its representation of expert knowledge from over 15 countries, offering both comprehensive papers that provide foundational insights into specific topics and concise contributions that emphasize particular applications in various security domains.
Pharmaceutical Product Development
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Author : Chilukuri Dakshina Murthy
language : en
Publisher: CRC Press
Release Date : 2007-02-12
Pharmaceutical Product Development written by Chilukuri Dakshina Murthy and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-02-12 with Medical categories.
During the last two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner. To meet these ends, pharmaceutical scientists working in the differing areas of pharmacy, pharmaceutics, and phar
Generic Drug Product Development
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Author : Isadore Kanfer
language : en
Publisher: CRC Press
Release Date : 2007-11-15
Generic Drug Product Development written by Isadore Kanfer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-15 with Medical categories.
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important comp
Integrated Pharmaceutics
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Author : Antoine Al-Achi
language : en
Publisher: John Wiley & Sons
Release Date : 2022-09-07
Integrated Pharmaceutics written by Antoine Al-Achi and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-09-07 with Medical categories.
This work is an examination of all aspects of the science in developing effective dosage form for drug delivery Pharmaceutics refers to the subfield of pharmaceutical sciences that develops drug delivery products or devices to optimize the drug's performance once administered. This multidisciplinary field draws on physical chemistry, organic chemistry, and biophysics to generate and refine these crucial elements of medical care. Moreover, incorporating such disparate dimensions of drug product design as material properties and legal regulation bridges the gap between effective chemicals and viable medical treatments. Integrated Pharmaceutics provides a comprehensive introduction to the creation and manufacture of effective dosage forms for drug delivery. It presents its subject following the principles of physical pharmacy, product design, and drug regulations. This tripartite structure allows readers to move from theory to practice, beginning from a firm foundation of physical pharmacy principles, including drug solubility and stability estimation, rheology, and interfacial properties. From there, it proceeds to discussions of drug product design and of harmonizing pharmaceutical design with the regulatory regimens and technological standards of the United States, European Union, and Japan. Readers of the second edition of Integrated Pharmaceutics will also find: A glossary defining key terms, extensive informative appendices, and a list of references leading to the primary literature in the field for each chapter Earlier chapters are expanded, with additional new chapters including one entitled “Biotechnology Products” Supplementary instructor guide with questions and solutions available online for registered professors Updated regulatory guidelines including quality by design, design space analysis, process analytical technology, polymorphism characterization, blend sample uniformity, and stability protocols Integrated Pharmaceutics is a useful textbook for graduate students in pharmaceutical sciences, drug formulation and design, and biomedical engineering. In addition, professionals in the pharmaceutical industry, including regulatory bodies, will find it a helpful reference guide.
Validation Of Pharmaceutical Processes
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Author : James P. Agalloco
language : en
Publisher: CRC Press
Release Date : 2007-09-25
Validation Of Pharmaceutical Processes written by James P. Agalloco and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-09-25 with Medical categories.
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Intelligent Control In Drying
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Author : Alex Martynenko
language : en
Publisher: CRC Press
Release Date : 2018-09-03
Intelligent Control In Drying written by Alex Martynenko and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Technology & Engineering categories.
Despite the available general literature in intelligent control, there is a definite lack of knowledge and know-how in practical applications of intelligent control in drying. This book fills that gap. Intelligent Control in Drying serves as an innovative and practical guide for researchers and professionals in the field of drying technologies, providing an overview of control principles and systems used in drying operations, from classical to model-based to adaptive and optimal control. At the same time, it lays out approaches to synthesis of control systems, based on the objectives and control strategies, reflecting complexity of drying process and material under drying. This essential reference covers both fundamental and practical aspects of intelligent control, sensor fusion and dynamic optimization with respect to drying.
Sterile Drug Products
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Author : Michael J. Akers
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Sterile Drug Products written by Michael J. Akers and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This
Challenges In Protein Product Development
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Author : Nicholas W. Warne
language : en
Publisher: Springer
Release Date : 2018-06-20
Challenges In Protein Product Development written by Nicholas W. Warne and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-20 with Medical categories.
In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.