Pegylated Protein Drugs Basic Science And Clinical Applications

PEGylation technology and key applications are introduced by this topical volume. Basic physical and chemical properties of PEG as basis for altering/improving in vivo behaviour of PEG-conjugates such as increased stability, improved PK/PD, and decreased immunogenicity, are discussed. Furthermore, chemical and enzymatic strategies for the coupling and the conjugate characterization are reported. Following chapters describe approved and marketed PEG-proteins and PEG-oligonucleotides as well as conjugates in various stages of clinical development.

A comprehensive discussion of various types of nanoengineered biomaterials and their applications In Nanoengineering of Biomaterials: Drug Delivery & Biomedical Applications, an expert team of chemists delivers a succinct exploration of the synthesis, characterization, in-vitro and in-vivo drug molecule release, pharmacokinetic activity, pharmacodynamic activity, and the biomedical applications of several types of nanoengineered biomaterials. The editors have also included resources to highlight the most current developments in the field. The book is a collection of valuable and accessible reference sources for researchers in materials chemistry and related disciplines. It uses a functions-directed approach to using organic and inorganic source compounds that translate into biological systems as scaffolds, micelles, dendrimers, and other delivery systems. Nanoengineering of Biomaterials offers readers up-to-date chemistry and material science insights that are readily transferrable to biomedical systems. The book also includes: Thorough introductions to alginate nanoparticle delivery of therapeutics and chitosan-based nanomaterials in biological applications Comprehensive explorations of nanostructured carrageenan as a drug carrier, gellan gum nanoparticles in drug delivery, and guar-gum nanoparticles in the delivery of bioactive molecules Practical discussions of protein-based nanoparticles for drug delivery, solid lipid nanoparticles as drug carriers, and pH-responsive nanoparticles in therapy In-depth examinations of stimuli-responsive nano carriers in drug targeting Perfect for pharmaceutical chemists, materials scientists, polymer chemists, life scientists, and medicinal chemists, Nanoengineering of Biomaterials: Drug Delivery and Biomedical Applications is also an indispensable resource for biologists and bioengineers seeking a one-stop reference on the transferability of materials chemistry and nanotechnology to biomedicine.

This book is the second in a series presenting articles that received the most citations in recent years in nanomedicine. The series is edited by, a prominent nanotechnology researcher and editor-in-chief of Precision Nanomedicine. The theme of the second volume is about nano-enabled medical applications. The 19 articles collected here have already acquired more than 12,500 citations highlighting the importance and professional recognition of the work of these scientists in nanomedicine. The content includes the general overview of the field and a wide variety of applications that have been impossible without nanoscience and nanotechnology.

Engineering of Biomaterials for Drug Delivery Systems: Beyond Polyethylene Glycol examines the combined issues of PEGylation and viable biomaterials as alternatives. With a strong focus on polymeric biomaterials, the book first reviews the major issues associated with PEGylation and its use in vivo. Chapters then focus on alternative polymer systems for drug delivery systems. Finally, nanoparticles and future perspectives are examined. This book is a valuable resource for scientists and researchers in biomaterials, pharmaceuticals and nanotechnology, and all those who wish to broaden their knowledge in this field. Provides a self-contained work for the field of biomaterials for drug delivery Summarizes the current knowledge on PEGylation and strategies for bypassing it Presents research on an important, though under-represented issue in biomaterials Written by a world-class team of research scientists, engineers and clinicians

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

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

This book surveys the field of long acting injections and implants, which improve therapy, enhance patient compliance, and enhance dosing convenience. Topics include the historical development of drugs and diseases, and clinical applications for long acting injections and implants.

This book describes preparation techniques for well-defined, customizable poly(organo)phosphazene materials and their applications in nanomedicine, i.e. as macromolecular carriers for drug delivery, immunology, gene therapy, or tissue regeneration. This 2nd edition of Polyphosphazenes for Medical Applications has been updated and extended for researchers in the field as well as those considering using polyphosphazenes for a specific application.