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Robust Process Development and Scientific Molding

Robust Process Development and Scientific Molding Book
Author : Suhas Kulkarni
Publisher : Carl Hanser Verlag GmbH Co KG
Release : 2017-01-16
ISBN : 1569905878
Language : En, Es, Fr & De

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Book Description :

The book introduces the reader to the concepts of Scientific Molding and Scientific Processing for Injection Molding, geared towards developing a robust, repeatable, and reproducible (3Rs) molding process. The effects of polymer morphology, thermal transitions, drying, and rheology on the injection molding process are explained in detail. The development of a robust molding process is broken down into two sections and is described as the Cosmetic Process and the Dimensional Process. Scientific molding procedures to establish a 3R process are provided. The concept of Design of Experiments (DOEs) for and in injection molding is explained, providing an insight into the cosmetic and dimensional process windows. A plan to release qualified molds into production with troubleshooting tips is also provided. Topics that impact a robust process such as the use of regrind, mold cooling, and venting are also described. Readers will be able to utilize the knowledge gained from the book in their day-to-day operations immediately. The second edition includes a completely new chapter on Quality Concepts, as well as much additional material throughout the book, covering fountain flow, factors affecting post mold shrinkage, and factor selections for DOEs. There are also further explanations on several topics, such as in-mold rheology curves, cavity imbalances, intensification ratios, gate seal studies, holding time optimization of hot runner molds, valve gated molds, and parts with large gates. A troubleshooting guide for common molded defects is also provided.

Robust Process Development and Scientific Molding Second Edition

Robust Process Development and Scientific Molding  Second Edition   Book
Author : Anonim
Publisher : Unknown
Release : 2015
ISBN : 9781523111862
Language : En, Es, Fr & De

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Book Description :

Download Robust Process Development and Scientific Molding Second Edition book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Industrial Applications of Robust Process Development Project Planning

Industrial Applications of Robust Process Development Project Planning Book
Author : P. K. Basu,B. Houston,R. A. Mack,American Institute of Chemical Engineers
Publisher : Unknown
Release : 1998
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Industrial Applications of Robust Process Development Project Planning book written by P. K. Basu,B. Houston,R. A. Mack,American Institute of Chemical Engineers, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book
Author : Feroz Jameel,Susan Hershenson
Publisher : John Wiley & Sons
Release : 2010-08-09
ISBN : 0470118121
Language : En, Es, Fr & De

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Book Description :

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.

Development of a Mold Trial Procedure for Establishing a Robust Process

Development of a Mold Trial Procedure for Establishing a Robust Process Book
Author : Marc R. Vander Kooi
Publisher : Unknown
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Development of a Mold Trial Procedure for Establishing a Robust Process book written by Marc R. Vander Kooi, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Process Development for the Robust Production of Polyhydroxyalkanoates

Process Development for the Robust Production of Polyhydroxyalkanoates Book
Author : Anna Ferré
Publisher : Unknown
Release : 2018
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Process Development for the Robust Production of Polyhydroxyalkanoates book written by Anna Ferré, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Handbook of Pharmaceutical Biotechnology

Handbook of Pharmaceutical Biotechnology Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2007-05-25
ISBN : 9780470117101
Language : En, Es, Fr & De

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Book Description :

A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and validation methods Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry.

Vaccine Development and Manufacturing

Vaccine Development and Manufacturing Book
Author : Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Publisher : John Wiley & Sons
Release : 2014-11-17
ISBN : 0470261943
Language : En, Es, Fr & De

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Book Description :

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies Authors from different major pharmaceutical and biotechnology companies Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

Advanced Nanoscale ULSI Interconnects Fundamentals and Applications

Advanced Nanoscale ULSI Interconnects  Fundamentals and Applications Book
Author : Yosi Shacham-Diamand,Tetsuya Osaka,Madhav Datta,Takayuki Ohba
Publisher : Springer Science & Business Media
Release : 2009-09-19
ISBN : 9780387958682
Language : En, Es, Fr & De

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Book Description :

In Advanced ULSI interconnects – fundamentals and applications we bring a comprehensive description of copper-based interconnect technology for ultra-lar- scale integration (ULSI) technology for integrated circuit (IC) application. In- grated circuit technology is the base for all modern electronics systems. You can ?nd electronics systems today everywhere: from toys and home appliances to a- planes and space shuttles. Electronics systems form the hardware that together with software are the bases of the modern information society. The rapid growth and vast exploitation of modern electronics system create a strong demand for new and improved electronic circuits as demonstrated by the amazing progress in the ?eld of ULSI technology. This progress is well described by the famous “Moore’s law” which states, in its most general form, that all the metrics that describe integrated circuit performance (e. g. , speed, number of devices, chip area) improve expon- tially as a function of time. For example, the number of components per chip d- bles every 18 months and the critical dimension on a chip has shrunk by 50% every 2 years on average in the last 30 years. This rapid growth in integrated circuits te- nology results in highly complex integrated circuits with an increasing number of interconnects on chips and between the chip and its package. The complexity of the interconnect network on chips involves an increasing number of metal lines per interconnect level, more interconnect levels, and at the same time a reduction in the interconnect line critical dimensions.

Pharmaceutical Process Development

Pharmaceutical Process Development Book
Author : John Blacker,Michael T Williams
Publisher : Royal Society of Chemistry
Release : 2011-08-17
ISBN : 1849733074
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.

Materials for Advanced Packaging

Materials for Advanced Packaging Book
Author : Daniel Lu,C.P. Wong
Publisher : Springer
Release : 2016-11-18
ISBN : 3319450980
Language : En, Es, Fr & De

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Book Description :

Significant progress has been made in advanced packaging in recent years. Several new packaging techniques have been developed and new packaging materials have been introduced. This book provides a comprehensive overview of the recent developments in this industry, particularly in the areas of microelectronics, optoelectronics, digital health, and bio-medical applications. The book discusses established techniques, as well as emerging technologies, in order to provide readers with the most up-to-date developments in advanced packaging.

How to Integrate Quality by Efficient Design QbED in Product Development

How to Integrate Quality by Efficient Design  QbED  in Product Development Book
Author : Bhavishya Mittal
Publisher : Academic Press
Release : 2019-08-24
ISBN : 0128173041
Language : En, Es, Fr & De

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Book Description :

The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development Discusses relevant literature references in quality risk management, business strategy, QbD, and product development Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand

Microbial Process Development

Microbial Process Development Book
Author : H W Doelle
Publisher : World Scientific Publishing Company
Release : 1994-02-24
ISBN : 981310466X
Language : En, Es, Fr & De

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Book Description :

This book outlines the vast potential of the microbial catalyst for present and future microbial process development without waste formation, leading to a clean environment. It is intended to inspire scientists and biochemical engineers to isolate new microorganisms from nature and to explore the optimal potential of the genotype before altering its code through genetical engineering. This book is structured to encourage the reader to use basic scientific and biochemical engineering concepts for the development of new and improved fermentation technology industries. It leads the reader from aspects of isolation, identification and preservation of microbial strains to the use of thermodynamics and their biochemistry to the final endproducts and their purification. Special emphasis is given to the restoration of our present and the preservation of our future environment using socioecological and biotechnological concepts. Drawing on many years of experience teaching and working in the Asia-Pacific and Africa, the author presents an interesting, informative and enlightening account of his knowledge in this field. Request Inspection Copy

Animal Cell Biotechnology

Animal Cell Biotechnology Book
Author : Hansjörg Hauser,Roland Wagner
Publisher : Walter de Gruyter GmbH & Co KG
Release : 2014-11-10
ISBN : 3110278960
Language : En, Es, Fr & De

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Book Description :

This book introduces fundamental principles and practical application of techniques used in the scalable production of biopharmaceuticals with animal cell cultures. A broad spectrum of subjects relevant to biologics production and manufacturing are reviewed, including the generation of robust cell lines, a survey of functional genomics for a better understanding of cell lines and processes, as well as advances in regulatory compliant upstream and downstream development. The book is an essential reference for all those interested in translational animal cell-based pharmaceutical biotechnology.

Handbook of Industrial Cell Culture

Handbook of Industrial Cell Culture Book
Author : Victor A. Vinci,Sarad R. Parekh
Publisher : Springer Science & Business Media
Release : 2002-12-06
ISBN : 1592593461
Language : En, Es, Fr & De

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Book Description :

A diverse team of researchers, technologists, and engineers describe, in simple and practical language, the major current and evolving technologies for improving the biocatalytic capabilities of mammalian, microbial, and plant cells. The authors present state-of-the-art techniques, proven methods, and strategies for industrial screening, cultivation, and scale-up of these cells, and describe their biotech and industrial uses. Special emphasis is given to the solving critical issues encountered during the discovery of new drugs, process development, and the manufacture of new and existing compounds. Other topics include recombinant protein expression, bioinformatics, high throughput screening, analytical tools in biotechnology, DNA shuffling, and genomics discovery.

Amorphous Solid Dispersions

Amorphous Solid Dispersions Book
Author : Navnit Shah,Harpreet Sandhu,Duk Soon Choi,Hitesh Chokshi,A. Waseem Malick
Publisher : Springer
Release : 2014-11-21
ISBN : 1493915983
Language : En, Es, Fr & De

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Book Description :

This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. In twenty-three inclusive chapters, the book examines thermodynamics and kinetics of the amorphous state and amorphous solid dispersions, ASD technologies, excipients for stabilizing amorphous solid dispersions such as polymers, and ASD manufacturing technologies, including spray drying, hot melt extrusion, fluid bed layering and solvent-controlled micro-precipitation technology (MBP). Each technology is illustrated by specific case studies. In addition, dedicated sections cover analytical tools and technologies for characterization of amorphous solid dispersions, the prediction of long-term stability, and the development of suitable dissolution methods and regulatory aspects. The book also highlights future technologies on the horizon, such as supercritical fluid processing, mesoporous silica, KinetiSol®, and the use of non-salt-forming organic acids and amino acids for the stabilization of amorphous systems. Amorphous Solid Dispersions: Theory and Practice is a valuable reference to pharmaceutical scientists interested in developing bioavailable and therapeutically effective formulations of poorly soluble molecules in order to advance these technologies and develop better medicines for the future.

Process Scale Purification of Antibodies

Process Scale Purification of Antibodies Book
Author : Uwe Gottschalk
Publisher : John Wiley & Sons
Release : 2017-03-07
ISBN : 1119126932
Language : En, Es, Fr & De

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Book Description :

Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing

Novel Process Windows

Novel Process Windows Book
Author : Volker Hessel,Dana Kralisch,Norbert Kockmann
Publisher : John Wiley & Sons
Release : 2014-12-22
ISBN : 3527328580
Language : En, Es, Fr & De

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Book Description :

This book introduces the concept of novel process windows, focusing on cost improvements, safety, energy and eco-efficiency throughout each step of the process. The first part presents the new reactor and process-related technologies, introducing the potential and benefit analysis. The core of the book details scenarios for unusual parameter sets and the new holistic and systemic approach to processing, while the final part analyses the implications for green and cost-efficient processing. With its practical approach, this is invaluable reading for those working in the pharmaceutical, fine chemicals, fuels and oils industries.

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design Book
Author : Sarwar Beg,Md Saquib Hasnain
Publisher : Academic Press
Release : 2019-03-27
ISBN : 0128163720
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies