Download or read book ENHANZE Drug Delivery Technology written by David W. Kang and published by Karger Medical and Scientific Publishers. This book was released on 2022-06-30 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: ‘ENHANZE® drug delivery technology: Advancing subcutaneous drug delivery using recombinant human hyaluronidase PH20’ provides readers with in-depth information on the potential benefits and challenges of subcutaneous (SC) drug delivery, the biology of hyaluronan and hyaluronidases in the SC space, and a comprehensive overview on the history of hyaluronidases and the development of recombinant human hyaluronidase PH20 (rHuPH20). Current applications of rHuPH20 as well as approved biotherapeutics utilizing HuPH20-facilitated SC drug delivery are summarized, and the underlying non-clinical and clinical development approaches are introduced as a basis for future application to biologics in various disease areas. Table of Contents: • Introduction to subcutaneous drug delivery • Biology of hyaluronan and hyaluronidases in the subcutaneous space • History of hyaluronidases and development of rHuPH20 • The ENHANZE® platform: Clinical applications of a subcutaneous drug delivery technology • Application of ENHANZE® drug delivery technology: Development of currently marketed products
Download or read book Innovative delivery systems for paediatric medicines written by and published by World Health Organization. This book was released on 2021-11-10 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book I Byte Healthcare July 2021 written by IT Shades and published by EGBG Services LLC. This book was released on 2021-08-06 with total page 89 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document brings together a set of the latest data points and publicly available information relevant to the Healthcare Industry. We are very excited to share this content and believe that readers will immensely benefit from this periodic publication.
Download or read book Biologics and Biosimilars written by Xiaodong Feng and published by CRC Press. This book was released on 2022-06-13 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.
Download or read book Biopharmaceutics written by Hannah Batchelor and published by John Wiley & Sons. This book was released on 2021-12-20 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore the latest research in biopharmaceutics from leading contributors in the field In Biopharmaceutics - From Fundamentals to Industrial Practice, distinguished Scientists from the UK's Academy of Pharmaceutical Sciences Biopharmaceutica Focus Group deliver a comprehensive examination of the tools used within the field of biopharmaceutics and their applications to drug development. This edited volume is an indispensable tool for anyone seeking to better understand the field of biopharmaceutics as it rapidly develops and evolves. Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow. Readers will find insightful discussions of physiologically based modeling as a valuable asset in the biopharmaceutics toolkit and how to apply the principles of the field to special populations. The book goes on to discuss: Thorough introductions to biopharmaceutics, basic pharmacokinetics, and biopharmaceutics measures Comprehensive explorations of solubility, permeability, and dissolution Practical discussions of the use of biopharmaceutics to inform candidate drug selection and optimization, as well as biopharmaceutics tools for rational formulation design In-depth examinations of biopharmaceutics classification systems and regulatory biopharmaceutics, as well as regulatory biopharmaceutics and the impact of anatomy and physiology Perfect for professionals working in the pharmaceutical and biopharmaceutical industries, Biopharmaceutics - From Fundamentals to Industrial Practice is an incisive and up-to-date resource on the practical, pharmaceutical applications of the field.
Download or read book Polymer Protein Conjugates written by Gianfranco Pasut and published by Elsevier. This book was released on 2019-10-30 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: Polymer–Protein Conjugates: From Pegylation and Beyond helps researchers by offering a unique reference and guide into this fascinating area. Sections cover the challenges surrounding the homogeneity of conjugates, their purity and polymer toxicity on long-term use, and how to deal with the risk of immunogenicity. These discussions help researchers design new projects by taking into account the latest innovations for safe and site selective polymer conjugation to proteins. PEG has been the gold standard and likely will play this role for many years, but alternatives are coming into the market, some of which have already been launched. After five decades of improvements, the ideas in this book are entering into a new era of innovation because of the advances in genetic engineering, biochemistry and a better understanding of the results from clinical use of PEG conjugates in humans. Provides an overview on the state-of-the-art of protein polymer conjugation Presents both the pros and cons of polymer-protein conjugates from the point-of-view of their clinical outcomes Outlines advantages and potential risks of present technology based on PEG Offers new alternatives for PEG and new approaches for on site-selective protein modification Identifies future direction of research in this field
Download or read book Handbook of Pharmacokinetics and Toxicokinetics written by Mehdi Boroujerdi and published by CRC Press. This book was released on 2023-08-22 with total page 905 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fully revised and expanded volume is an effort to blend the common approaches to pharmacokinetics and toxicokinetics. It integrates the principles held in common by both fields through a logical and systematic approach, which includes mathematical descriptions of physical and physiological processes employed in the approaches to pharmacokinetics and toxicokinetics modeling. It emphasizes general principles and concepts and related, isolated applications and case study observations. The systematic compilation of mathematical concepts and methodologies allows readers to decide on relevant concepts and approaches for their research, scientific or regulatory decisions, or for offering advanced courses/workshops and seminars. Features: Comprehensive handbook on principles and applications of PK/TK appealing to a diverse audience including scientists and students An excellent text fully revised and fully updated for anyone interested in the theoretical and practical pharmacokinetics The systematic compilation of mathematical concepts and methodologies allows readers to decide on relevant concepts and approaches for their research Incorporates research relevant to SDGs and of interest to industrial and regulatory environmental scientists involved in chemical contamination research and regulatory decision making related to soil, water, and ocean Includes sections on applications and case studies
Download or read book Novel Drug Delivery Technologies written by Ambikanandan Misra and published by Springer Nature. This book was released on 2020-02-12 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: The application of drug delivery is a valuable, cost-effective lifecycle management resource. By endowing drugs with new and innovative therapeutic benefits, drug delivery systems extend products’ profitable lifecycle, giving pharmaceutical companies competitive and financial advantages, and providing patients with improved medications. Formulation development is now being used to create new dosage forms for existing products, which not only reduces the time and expense involved in new drug development, but also helps with regard to patent protection and bypassing existing patents. Today’s culture demands convenience, a major factor determining adherence to drug therapy. Over the past few years, patient convenience-oriented research in the field of drug delivery has yielded a range of innovative drug-delivery options. As a result, various drug-delivery systems, including medicated chewing gums, oral dispersible tablets, medicated lozenges and lollipops, have now hit the market and are very popular. These dosage forms offer a highly convenient way to dose medications, not only for special population groups with swallowing difficulties, such as children and the elderly, but for the general populace as well. This book provides valuable insights into a number of formulation design approaches that are currently being used, or could be used, to provide new benefits from existing drug molecules.
Download or read book BioScan written by and published by . This book was released on 2009 with total page 1268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Genetic Engineering Biotechnology News written by and published by . This book was released on 2007 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Therapeutic Enzymes Function and Clinical Implications written by Nikolaos Labrou and published by Springer Nature. This book was released on 2019-09-03 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Therapeutic enzymes exhibit fascinating features and opportunities, and represent a significant and promising subcategory of modern biopharmaceuticals for the treatment of several severe diseases. Research and drug developments efforts and the advancements in biotechnology over the past twenty years have greatly assisted the introduction of efficient and safe enzyme-based therapies for a range of both rare and common disorders. The introduction and regulatory approval of twenty different recombinant enzymes has enabled effective enzyme-replacement therapy. This volume aims to overview these therapeutic enzymes, focusing in particular on more recently approved enzymes produced by recombinant DNA technology. This volume is composed of four sections. Section 1 provides an overview of the production process and biochemical characterization of therapeutic enzymes, while Section 2 focuses upon the engineering strategies and delivery methods of therapeutic enzymes. Section 3 highlights the clinical applications of approved therapeutic enzymes, including aspects on their structure, indications and mechanisms of action. Together with information on these mechanisms, safety and immunogenicity issues and various adverse events of the recombinant enzymes used for therapy are discussed. Section 4, provides discussion on the prospective and future developments of new therapeutic enzymes. This book is aimed at academics, researchers and students undertaking advanced undergraduate/postgraduate programs in the biopharmaceutical/biotechnology area who wish to gain a comprehensive understanding of enzyme-based therapeutic molecules.
Download or read book Oral Delivery of Macromolecular Drugs written by Andreas Bernkop-Schnürch and published by Springer Science & Business Media. This book was released on 2009-08-04 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent and rapid progress in the field of biotechnology has resulted in an increasing number of novel macromolecular drugs with great promise for further advanced research and clinical application. However, the delivery of these macromolecular drugs by routes other than the parenteral route is difficult. The pipeline of macromolecular drugs derived from biotechnology presents a challenging opportunity to develop practical dosage forms that could be dosed via the oral route. Given this, the successful oral delivery of macromolecular drugs presents an enormous opportunity. Oral Delivery of Macromolecular Drugs will provide an overview of the innovative oral delivery technologies that have demonstrated success in human testing and will go on to cite the challenges, strategies, and future trends that are to be expected.
Download or read book Current Trends in Monoclonal Antibody Development and Manufacturing written by Steven J. Shire and published by Springer Science & Business Media. This book was released on 2009-11-11 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.
Download or read book 3D Printing of Pharmaceuticals and Drug Delivery Devices written by Dimitrios A. Lamprou and published by MDPI. This book was released on 2020-07-01 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 3D printing (3DP) process was patented in 1986; however, only in the last decade has it begun to be used for medical applications, as well as in the fields of prosthetics, bio-fabrication, and pharmaceutical printing. 3DP or additive manufacturing (AM) is a family of technologies that implement layer-by-layer processes in order to fabricate physical models based on a computer aided design (CAD) model. 3D printing permits the fabrication of high degrees of complexity with great reproducibility in a fast and cost-effective fashion. 3DP technology offers a new paradigm for the direct manufacture of individual dosage forms and has the potential to allow for variations in size and geometry as well as control dose and release behavior. Furthermore, the low cost and ease of use of 3DP systems means that the possibility of manufacturing medicines and medical devices at the point of dispensing or at the point of use could become a reality. 3DP thus offers the perfect innovative manufacturing route to address the critical capability gap that hinders the widespread exploitation of personalized medicines for molecules that are currently not easy to deliver. This Special Issue will address new developments in the area of 3D printing and bioprinting for drug delivery applications, covering the recent advantages and future directions of additive manufacturing for pharmaceutical products.
Download or read book Challenges in Protein Product Development written by Nicholas W. Warne and published by Springer. This book was released on 2018-06-20 with total page 599 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.
Download or read book The Discovery of Insulin written by Michael Bliss and published by University of Toronto Press. This book was released on 2017-06-22 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: The discovery of insulin at the University of Toronto in 1921-22 was one of the most dramatic events in the history of the treatment of disease. Insulin was a wonder-drug with ability to bring patients back from the very brink of death, and it was no surprise that in 1923 the Nobel Prize for Medicine was awarded to its discoverers, the Canadian research team of Banting, Best, Collip, and Macleod. In this engaging and award-winning account, historian Michael Bliss recounts the fascinating story behind the discovery of insulin – a story as much filled with fiery confrontation and intense competition as medical dedication and scientific genius. Originally published in 1982 and updated in 1996, The Discovery of Insulin has won the City of Toronto Book Award, the Jason Hannah Medal of the Royal Society of Canada, and the William H. Welch Medal of the American Association for the History of Medicine.
Download or read book Carbohydrate Bioengineering written by S.B. Petersen and published by Elsevier. This book was released on 1995-12-08 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Carbohydrate Bioengineering Meeting held in Elsinore, Denmark, April 23-26, 1995, gathered 230 scientists, mostly from Europe, with interest in carbohydrate analysis and structure; carbohydrates in medicine and glycopathology; structure, function, application, and protein engineering of carbohydrate active enzymes; oligo- and polysaccharides of industrial interest; and production of carbohydrate containing new materials. The first chapters address glycoconjugates as modulatory and recognition molecules, structure determination using NMR and mass spectrometry, and microdialysis-chip enzyme-based sensors. Active site mutations coupled with crystal structures and synthetic substrate analogue interactions as well as new three-dimensional structures and binding domains for biotechnological applications are included in the chapters. Carbohydrate active enzymes turned out to be a predominant topic. The rapid development in glycobiology and glycotechnology has resulted in an enormous increase in our knowledge on the structure conversion, and application of carbohydrates in industry and medicine.
