Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters. Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure HOS or conformation of protein based drugs.
Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly. This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytica.
Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than , with at least more in various stages of development. That alone would be grounds for a new edition. Add to that the fact. Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational.
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. In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns.
As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control.
The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sc.
Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods.
Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps , computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology.
All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications.
Handbook of Preformulation Author : Sarfaraz K. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this fully revised and updated Handbook of Preforumulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.
Razinkov Publisher : Woodhead Publishing Release Date : Genre: Medical Pages : ISBN 10 : GET BOOK High Throughput Formulation Development of Biopharmaceuticals Book Description : High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development.
The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary. Presents applications of high-throughput methodologies to accelerate drug formulation development Provides the latest technologies in the field Includes key statistical approaches, such as design of experiment and multivariate data analysis Written by highly respected formulation development experts.
Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. Presents basic protein characterization methods and tools applicable to bio pharmaceutical research and development Highlights the capabilities and limitations of each technique Discusses the underlining science of each tool Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry.
The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Formulation and process development strategies for manufacturing biopharmaceuticals.
Hawe A, et al. Forced degradation of therapeutic proteins. Houde D, Berkowitz S, editors. Biophysical characterization of proteins in developing biopharmaceuticals. Elsevier B. Jiskoot W, et al. Protein instability and immunogenicity: roadblocks to clinical application of injectable protein delivery systems for sustained release.
Jiskoot W, Crommelin D, editors. Methods for structural analysis of protein pharmaceuticals. Joshi SB, et al. An empirical phase diagram-high-throughput screening approach to the characterization and formulation of biopharmaceuticals. Kalonia C, et al. Radar chart array analysis to visualize effects of formulation variables on IgG1 particle formation as measured by multiple analytical techniques.
Kerwin BA. Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways. Analysis methods of polysorbate a new method to assess the stability of polysorbate 20 and established methods that may overlook degraded polysorbate Kirshner LS. Regulatory expectations for analysis of aggregates and particles. In: Colorado protein stability conference. Breckenridge, CO. Development of formulations for therapeutic monoclonal antibodies and Fc fusion proteins.
In: Jameel J, Hershenson S, editors. New Jersey, NJ: Wiley; Labrenz SR. Ester hydrolysis of polysorbate 80 in mAb drug product: evidence in support of the hypothesized risk after the observation of visible particulate in mAb formulations.
Pain perception after subcutaneous injections of media containing different buffers. Basic Clin Pharm Toxycology. Mahler H-C, et al. Behaviour of polysorbate 20 during dialysis, concentration and filtration using membrane separation techniques. Mahler HC, Jiskoot W, editors. Analysis of aggregates and particles in protein pharmaceuticals. New York, NY: Wiley; Manning MC, et al. Stability of protein pharmaceuticals: an update.
Overcoming the challenges in administering biopharmaceuticals: formulation and delivery strategies. Nat Rev Drug Discovery. Monnier VM. Nonenzymatic glycosylation, the maillard reaction and the aging process. J Gerontol. Nayar R, Manning MC. High throughput formulation: strategies for rapid development of stable protein products.
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