Download or read book Protein Adsorption to Vial Surfaces Quantification Structural and Mechanistic Studies written by Johannes Mathes and published by Cuvillier Verlag. This book was released on 2010-09-21 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adsorption of therapeutic proteins to different surfaces in the course of fill and finish, storage, or administration is critical and has shown to cause severe problems which should not be underestimated. Among them is the loss of content but also, potentially, protein structural changes, accompanied by the risk of therapy failure or immunological reactions. In this context, special attention has to be paid to primary packaging containers, to which the protein has an enduring surface contact. Against this background, the adsorption of a modern therapeutic protein, i.e. an IgG1 antibody, to vials was investigated within the scope of this thesis. The first priority had borosilicate glass, followed by siliconized borosilicate glass and polyolefin plastic. The use of model surfaces was almost completely avoided. The studies comprise the quantification of surface-bound protein subject to variable formulation compositions and surface qualities as well as a detailed characterization of the adsorbed protein layer including protein structural alterations caused by the adsorption process. In the presented investigations, the main focus was on the equilibrium state of adsorption at conditions mainly within the scope of pharmaceutical relevance, but also beyond, if necessary, for the acquisition of fundamental knowledge on the adsorption mechanism.
Download or read book Protein Adsorption to Vial Surfaces written by Johannes Maximilian Mathes and published by . This book was released on 2010 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Investigations on Protein Adsorption to Coated Glass Vials written by Kerstin Höger and published by . This book was released on 2014 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Dosage Forms written by Sandeep Nema and published by CRC Press. This book was released on 2010-08-26 with total page 1168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products
Download or read book Pharmaceutical Dosage Forms Parenteral Medications written by Sandeep Nema and published by CRC Press. This book was released on 2016-04-19 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the
Download or read book Proteins at Solid Liquid Interfaces written by Philippe Déjardin and published by Springer Science & Business Media. This book was released on 2006-09-28 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book opens with a description of fundamental aspects of protein adsorption to surfaces, a phenomenon that plays a key role in biotechnological applications, especially at solid-liquid interfaces. Presented here are methods for studying adsorption kinetics and conformational changes such as optical waveguide lightmode spectroscopy (OWLS). Also described are sensitive bench techniques for measuring the orientation and structure of proteins at solid-liquid interfaces, including total internal reflection ellipsometry (TIRE), dual polarisation interferometry (DPI) and time of flight - secondary ion mass spectrometry (TOF–SIMS). A model study of fibronectin at polymer surfaces is included, as are studies using microporous membranes and textiles with immobilized enzymes for large-scale applications. Biocompatibility, anti-fouling properties and surface modification to modulate the adsorption and activity of biomolecules are among the other topics addressed in this invaluable book.
Download or read book Proteins at Surfaces written by Yulia Mikhailovna Efimova and published by IOS Press. This book was released on 2006 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding protein adsorption is of vital importance in many fields of medicine and industry that can be divided into two categories: those in which it is desired to minimize adsorption, and those in which protein adsorption is desired. The first category covers materials for kidney dialysis membranes, implants in the bloodstream, vessels for storing pharmaceutical products, marine antifouling paints, etc. The second covers mainly materials for surgical implants, e.g., bone replacement, teeth implants, which must be assimilated with the living tissue. For example, bones or tooth implants require good protein adhesion to allow the growth of the bone and the formation of a stable and strong interphase between the implants and the bone. In contrast, the protein adhesion has to be poor for catheters or contact lenses, where a low contact with the tissue is required...
Download or read book Parenteral Medications Fourth Edition written by Sandeep Nema and published by CRC Press. This book was released on 2019-07-19 with total page 1125 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements
Download or read book Studies on Stable Formulations for a Hydrophobic Cytokine written by Andrea Hawe and published by Cuvillier Verlag. This book was released on 2006 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Protein Adsorption to Surfaces with Varying Characteristics written by Yeong-Shang Lin and published by . This book was released on 1993 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biological Drug Products written by Wei Wang and published by John Wiley & Sons. This book was released on 2013-08-29 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
Download or read book Pharmaceutical Inhalation Aerosol Technology Third Edition written by Anthony J. Hickey and published by CRC Press. This book was released on 2019-03-26 with total page 730 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Download or read book Protein Instability at Interfaces During Drug Product Development written by Jinjiang Li and published by Springer Nature. This book was released on 2021-02-12 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Protein adsorption on hydrophobic surfaces from intrinsically unstructured proteins to antibodies written by and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Excipients written by Otilia M. Y. Koo and published by John Wiley & Sons. This book was released on 2016-10-03 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Adsorption of Proteins and Interactions with Surfactants at the Solid liquid Interface written by Marie Wahlgren and published by . This book was released on 1992 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt:
