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Novel Enzyme/DNA/inorganic Materials
The very first examples of protein/DNA/inorganic nanocomposite materials are described. Surprisingly, the presence of DNA enhanced the properties of the bound protein. The layered inorganic solid, alpha-Zr(IV) phosphate (alpha-Zr(HPO4)2.H2O, abbreviated as alpha-ZrP) served as an excellent host for these studies, and the binding has been carried out under benign conditions (aqueous solutions at room temperature and neutral pH). These novel nanobiocomposite materials provide a simple method for the binding of DNA to negatively charged solids, and such approaches aid in engineering more effective synthetic materials for gene-delivery, RNA-delivery and drug delivery applications.
Development of Biopharmaceutical Drug-Device Products
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) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most...
Advanced Materials Research Trends
Advanced materials can be defined in numerous ways; the broadest definition is to refer to all materials that represent advances over the traditional materials that have been used for hundreds or even thousands of years. From this perspective advanced materials refer to all new materials and modifications to existing materials to obtain superior performance in one or more characteristics that are critical for the application under consideration. A more insightful and focused approach to advanced materials is to consider materials that are early in their product and/or technology lifecycle. In other words, there is significant room for growth in terms of the improvement of the performance characteristics (technology lifecycle) and their product lifecycle. The book presents new and important research in the field.
Drying Technologies for Biotechnology and Pharmaceutical Applications
A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during dr...
Handbook of Layered Materials
Focusing on layered compounds at the core of materials intercalation chemistry, this reference comprehensively explores clays and other classes of materials exhibiting the ability to pillar, or establish permanent intracrystalline porosity within layers. It offers an authoritative presentation of their fundamental properties as well as summaries of
Principles and Practices of Lyophilization in Product Development and Manufacturing
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 ...
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
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 pa...
Lyophilized Biologics and Vaccines
This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to...
Therapeutic Protein Drug Products
Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations...
Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies
Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies takes a look at the current strategies, successes and challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest trends in the development of diverse modalities will appeal to a broad community of scientists, students and clinicians. Written by leading authors across academia and industry, this book covers important topics such as unique drug delivery devices, non-parenteral delivery trends, novel approaches to the treatment of cancer, immunotherapy and more. It includes real-world cases and examples which highlight formulations wit...
