Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

The book addresses the basics, applications, and manufacturing of plasmid biopharmaceuticals. The survey of the most relevant characteristics of plasmids provides the basics for designing plasmid products (applications) and processes (manufacturing). Key features that the authors include in the book are: i) consistency and clear line of direction, ii) an extensive use of cross-referencing between the individual chapters, iii) a rational integration of chapters, iv) appellative figures, tables and schemes, and v) an updated, but selected choice of references, with a focus on key papers.

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

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

This book describes recent progress in enzyme-driven green syntheses of industrially important molecules. The first three introductory chapters overview recent technological advances in enzymes and cell-based transformations, and green chemistry metrics for synthetic efficiency. The remaining chapters are directed to case studies in biotechnological production of pharmaceuticals (small molecules, natural products and biologics), flavors, fragrance and cosmetics, fine chemicals, value-added chemicals from glucose and biomass, and polymeric materials. The book is aimed to facilitate the industrial applications of this powerful and emerging green technology, and catalyze the advancement of the technology itself.

A practical guide to semiconductor manufacturing from process control to yield modeling and experimental design Fundamentals of Semiconductor Manufacturing and Process Control covers all issues involved in manufacturing microelectronic devices and circuits, including fabrication sequences, process control, experimental design, process modeling, yield modeling, and CIM/CAM systems. Readers are introduced to both the theory and practice of all basic manufacturing concepts. Following an overview of manufacturing and technology, the text explores process monitoring methods, including those that focus on product wafers and those that focus on the equipment used to produce wafers. Next, the text sets forth some fundamentals of statistics and yield modeling, which set the foundation for a detailed discussion of how statistical process control is used to analyze quality and improve yields. The discussion of statistical experimental design offers readers a powerful approach for systematically varying controllable process conditions and determining their impact on output parameters that measure quality. The authors introduce process modeling concepts, including several advanced process control topics such as run-by-run, supervisory control, and process and equipment diagnosis. Critical coverage includes the following: * Combines process control and semiconductor manufacturing * Unique treatment of system and software technology and management of overall manufacturing systems * Chapters include case studies, sample problems, and suggested exercises * Instructor support includes electronic copies of the figures and an instructor's manual Graduate-level students and industrial practitioners will benefit from the detailed exami?nation of how electronic materials and supplies are converted into finished integrated circuits and electronic products in a high-volume manufacturing environment. An Instructor's Manual presenting detailed solutions to all the problems in the book is available from the Wiley editorial department. An Instructor Support FTP site is also available.

Green, clean and renewable are the hottest keywords for catalysis and industry. This handbook and ready reference is the first to combine the fields of advanced experimentation and catalytic process development for biobased materials in industry. It describes the entire workflow from idea, approach, research, and process development, right up to commercialization. A large part of the book is devoted to the use of advanced technologies and methodologies like high throughput experimentation, as well as reactor and process design models, with a wide selection of real-life examples included at each stage. The contributions are from authors at leading companies and institutes, providing firsthand information and knowledge that is hard to find elsewhere. This work is aimed at decision makers, engineers and chemists in industry, chemists and engineers working with/on renewables, chemists in the field of catalysis, and chemical engineers.

This book covers recent developments in process systems engineering (PSE) for efficient resource use in biomass conversion systems. It provides an overview of process development in biomass conversion systems with focus on biorefineries involving the production and coproduction of fuels, heating, cooling, and chemicals. The scope includes grassroots and retrofitting applications. In order to reach high levels of processing efficiency, it also covers techniques and applications of natural-resource (mass and energy) conservation. Technical, economic, environmental, and social aspects of biorefineries are discussed and reconciled. The assessment scales vary from unit- to process- and life-cycle or supply chain levels. The chapters are written by leading experts from around the world, and present an integrated set of contributions. Providing a comprehensive, multi-dimensional analysis of various aspects of bioenergy systems, the book is suitable for both academic researchers and energy professionals in industry.

In today’s competitive economy, companies often augment in-house production by outsourcing chemical reaction processes and distillation, drying, formulating, blending, and packaging operations. While most of these tolling, or contracted manufacturing services, proceed without incident, recent major accidents have pointed to weaknesses in some tolling arrangements, such as reactivity of materials and processes. This Guidelines book provides the reader with proven procedures to improve process safety throughout the life cycle of a contracted manufacturing operation. Extensive checklists and examples used throughout the book make it a valuable learning tool and reference for companies conducting toll manufacturing, or considering outsourcing manufacturing operations.

Guiding readers through all steps of the complex process, this book covers the most diverse aspects of chemicals production, including those not or insufficiently covered in natural science courses. These comprise economic feasibility, patenting and licensing, demands on the location and the problem of waste disposal. Throughout, the author does not rely on simple references to other literature but instead reiterates many facts and places them in context, as well as succinctly explaining formulas, thus removing the need to look up items in secondary reference works. As such, the book is suitable for both newcomers as well as those already working in the field. Those working in R&D as well as plant managers will learn how to avoid pitfalls, resulting in higher safety. A common basis and indispensable ready reference for engineers and chemists.

This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that promotes safe laboratory practices, procedures and use of containment equipment and facilities. Additionally, biomedical engineers, biologists, or other professionals without chemical engineering training or knowledge of inherently safe design are designing many of these facilities.