Principles Of Parenteral Solution Validation
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Principles Of Parenteral Solution Validation
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Author : Igor Gorsky
language : en
Publisher: Academic Press
Release Date : 2019-11-27
Principles Of Parenteral Solution Validation written by Igor Gorsky and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-27 with Medical categories.
Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area.
Handbook Of Cell And Gene Therapy
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Author : Hazel Aranha
language : en
Publisher: CRC Press
Release Date : 2023-03-17
Handbook Of Cell And Gene Therapy written by Hazel Aranha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-17 with Science categories.
This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish, as well as delivery options. Planning steps for compliance with current good manufacturing practice (cGMP) to readiness for chemistry, manufacturing and controls (CMC) are also discussed. This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor. Features Provides the most up-to-date information on the development of gene therapy, from the technology involved to gene correction and genome editing Discusses siRNA, mRNA, and plasmid manufacturing Describes the importance of supplier-sponsor synergies on the path to commercialization Written for a diverse audience with a large number of individuals in the core technologies and supportive practices It is intended as a one-stop resource for the availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions.
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
Russell Hugo And Ayliffe S Principles And Practice Of Disinfection Preservation And Sterilization
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Author : Adam P. Fraise
language : en
Publisher: John Wiley & Sons
Release Date : 2013-02-18
Russell Hugo And Ayliffe S Principles And Practice Of Disinfection Preservation And Sterilization written by Adam P. Fraise 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 2013-02-18 with Medical categories.
The new edition of this established and highly respected text is THE definitive reference in its field. It details methods for the elimination or prevention/control of microbial growth, and features: New chapters on bioterrorism and community healthcare New chapters on microbicide regulations in the EU, USA and Canada Latest material on microbial resistance to microbicides Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Practical advice on problems of disinfection and antiseptics in healthcare A systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action with respect to current regulations The differences between European and North American regulations are highlighted throughout, making this a truly global work, ideal for worldwide healthcare professionals working in infectious diseases and infection control.
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.
Process Validation In Manufacturing Of Biopharmaceuticals
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Author : Anurag Singh Rathore
language : en
Publisher: CRC Press
Release Date : 2012-05-09
Process Validation In Manufacturing Of Biopharmaceuticals written by Anurag Singh Rathore and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-09 with Medical categories.
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.
Solid Oral Dose Process Validation
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Author : Ajay Babu Pazhayattil
language : en
Publisher: Springer
Release Date : 2018-11-16
Solid Oral Dose Process Validation written by Ajay Babu Pazhayattil and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-16 with Science categories.
Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.
Parenteral Medications Fourth Edition
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Author : Sandeep Nema
language : en
Publisher: CRC Press
Release Date : 2019-07-19
Parenteral Medications Fourth Edition written by Sandeep Nema and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-07-19 with Business & Economics categories.
Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements
Proceedings Of The International Conference On Computer Science Electronics And Industrial Engineering Csei 2023
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Author : Marcelo V. Garcia
language : en
Publisher: Springer Nature
Release Date : 2024-12-22
Proceedings Of The International Conference On Computer Science Electronics And Industrial Engineering Csei 2023 written by Marcelo V. Garcia and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-12-22 with Computers categories.
The Proceedings of the International Conference on Computer Science, Electronics and Industrial Engineering (CSEI 2023) focuses on "Innovations in Industrial Engineering and Robotics in Industry - Bridging the Gap Between Theory and Practical Application." This collection presents cutting-edge research and developments in the rapidly evolving fields of industrial engineering and robotics. Featuring peer-reviewed papers from leading researchers and practitioners, this volume explores the latest advancements in automation, smart manufacturing, and Industry 4.0 technologies. It offers valuable insights into how these innovations are reshaping industrial processes and driving efficiency across various sectors. The book addresses key challenges in implementing theoretical concepts in real-world industrial settings, providing practical solutions and case studies. Topics covered include advanced robotics systems, industrial IoT applications, sustainable manufacturing practices, and emerging trends in industrial automation. This volume is an essential resource for academics, engineers, and industry professionals seeking to stay at the forefront of industrial engineering and robotics. It serves as a bridge between academic research and industrial application, making it invaluable for both theoretical understanding and practical implementation in the field.
Principles Of Sterile Product Preparation
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Author :
language : en
Publisher: Amer Soc Health-System Pharmacists
Release Date : 1995
Principles Of Sterile Product Preparation written by and has been published by Amer Soc Health-System Pharmacists this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995 with Medical categories.