Masters Theses in the Pure and Applied Sciences


Book Description

Masters Theses in the Pure and Applied Sciences was first conceived, published, and disseminated by the Center for Information and Numerical Data Analysis and Synthesis (CINDAS)* at Purdue University in 1957, starting its coverage of theses with the academic year 1955. Beginning with Volume 13, the printing and dis semination phases of the activity were transferred to University Microfilms/Xerox of Ann Arbor, Michigan, with the thought that such an arrangement would be more beneficial to the academic and general scientific and technical community. After five years of this jOint undertaking we had concluded that it was in the interest of all concerned if the printing and distribution of the volumes were handled by an international publishing house to assure improved service and broader dissemination. Hence, starting with Volume 18, Masters Theses in the Pure and Applied Sciences has been disseminated on a worldwide basis by Plenum Publishing Corporation of New York, and in the same year the coverage was broadened to include Canadian universities. All back issues can also be ordered from Plenum. We have reported in Volume 40 (thesis year 1995) a total of 10,746 thesis titles from 19 Canadian and 144 United States universities. We are sure that this broader base for these titles reported will greatly enhance the value of this impor tant annual reference work. While Volume 40 reports theses submitted in 1995, on occasion, certain uni versities do report theses submitted in previous years but not reported at the time.




Protein Instability at Interfaces During Drug Product Development


Book Description

Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas.




Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition


Book Description

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology The physicochemical characteristics and stability of peptides and proteins The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids The opportunities and challenges of non-parenteral delivery of peptides and proteins Risk factors, specifically the development of an unwanted immune response A simulation approach to describe the fate of peptides and proteins upon administration to a biological system The documentation required to register a protein-based drug Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.




Food Proteins and Their Applications


Book Description

Reviews the physiochemical properties of the main food proteins and explores the interdependency between the structure-function relationship of specific protein classes and the processing technologies applied to given foods. The book offers solutions to current problems related to the complexity of food composition, preparation and storage, and includes such topics as foams, emulsions, gelation by macromolecules, hydrolysis, microparticles/fat replacers, protein-based edible films, and extraction procedures.




Biopharmaceutical Production Technology


Book Description

Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.




Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing


Book Description

Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing is a highly topical resource on a subject of interest for scientists and researchers working on monoclonal antibodies' characterization, release testing, stability testing and similarity assessments of monoclonal antibodies in the biopharmaceutical industry. Monoclonal antibodies (mAbs) are large, extremely complex and dynamic biomolecules, so it can be challenging to develop well-characterized therapeutic antibodies that meet regulatory expectations that are also in-line with commercialized standards for different drug markets. Lot release testing and understanding the stability of the mAb over a period of time, and in different environmental conditions, is an indispensable aspect of mAb physicochemical characterization. This book covers the process, including extensive analysis that starts with quantifying the purity attribute to glycan profiling and identifying the mAb primary structure. The book has a primary purpose of focusing on both Lot release testing and stability testing of monoclonal antibodies (subjects not covered in any great detail in other books). - Discusses, in detail, the Lot release methods for both drug substance and drug product, along with their importance in process sample analysis - Gives specific attention to general characteristics tests, such as pH determination, osmolality, sub-visible particle count, appearance and visible tests, and regulatory/pharmacopeial guidelines - Includes different kinds of stability testing (real time, accelerated and stressed) and their importance and determinations on product shelf life - Presents regulatory guidelines on ICH Q2R1, ICHQ6B and ICHQ5C, which are discussed along with analytical method validation, monoclonal antibodies physicochemical characterization and stability testing - Provides different characterization methods and validation and development case studies of monoclonal antibodies, including biosimilars and innovators




Pharmaceutical Excipients


Book Description

This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients







Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals


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.




Advances in Agronomy


Book Description

This volume in Advances in Agronomy contains seven outstanding reviews that discuss cutting edge developments in the crop and soil sciences. Chapter 1 addresses desertification and its relation to climate change. Chapter 2 discusses fate and transport of viruses in porous media. Chapter 3 is a comprehensive treatment of the future needs of root water and nutrient uptake modeling. Chapter 4 is a review on micronutrients in crop production, including a discussion on improving the supply and acquisition. Chapter 5 provides information on soils in tropical and temperate regions. Chapter 6 desribes free-air CO2 enrichment in agriculture. Lastly, chapter 7 discusses break crops and their application in organic agriculture.Advances in Agronomy continues to be recognized as a leading reference and a first-rate source of the latest and best research in agronomy. Major reviews deal with cutting edge issues of interest to agronomists, as well as crop and soil scientists. As always, the topics covered are varied and exemplary of the panoply of subject matter dealt with by this long-running serial. Donald Sparks is the editor and has been a president of the Soil Science Society of America.Advances in Agronomy has the highest impact factor among serial publications in Agriculture. The Science Citation Index, 1986, reports an impact factor over 2,459 and a cited half-life over 10 years.