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Cytokines
This book provides comprehensive coverage of the cytokines from a pharmacological approach. The chapters are presented in a consistent format allowing easy cross-reference, with sample diagrams and a summary table of essential facts for each chapter at the end of the book.Cytokines is unique in stressing cytokine biology and the application of research data to provide disease therapy. With 33 detailed and up-to-date chapters about individual cytokines, this comprehensive reference will provide both clinicians and researchers in immunology and pharmacology with invaluable information. - Genetic information and sequences - Protein structure - Cell sources and production - Biological activity - Cytokine receptor structure and signal transduction - Discussion of the role of cytokines in disease and the potential for therapy - Summary table of essential facts - Comprehensive bibliography
The United States Pharmacopeia, the National Formulary
The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. The current version of USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States.
Detection and Quantification of Antibodies to Biopharmaceuticals
The definitive book on the neutralization of recombinant biopharmaceuticals Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects. The first and only book to cover neutralization in connection with biopharmaceuticals and the measurement and application of neutralizing antibodies in modern medicine at any real length, Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations offers a comprehensi...
Immunogenicity of Therapeutic Biological Products
Immune responses to biological products have occurred with many approved therapeutics. The proportion of patients mounting an immune response is product dependent and the clinical significance of the immune response also varies with the nature of the product. Some products can induce production of significant levels of antibodies without any detectable effect on the activity of the product. However, neutralizing antibodies can attenuate the efficacy of the treatment and significant adverse clinical events can be seen if neutralizing antibodies cross-react with patients' endogenous proteins. Prediction of immunogenicity includes the use of bio-informatics to predict T-cell epitopes, T-cell stimulation assays and in vivo transgenic animal models. Approaches to prevent immunogenicity involve methods to design out immunogenic sequences, protein pegylation and inducing tolerance. Current methods for assessing and detecting immunogenicity include in vivo animal models, antibody assays and biological assays. The advantages and disadvantages of the various methods illustrate that a battery of tests is required to appropriately monitor patients' immune responses during clinical trials.
The Design and Analysis of Potency Assays for Biotechnology Products
The complexity of the structure and function of many biotechnology-derived products necessitates a wide range of analytical procedures to adequately characterize the product. Physicochemical techniques provide little, if any, information regarding the potency of biologicals. Therefore, the development and analysis of biological assays that measure the ability of a material to elicit a function are essential to successful product development. Bioassays such as in vivo or cell-based assays often exhibit inherent variability due to the use of living materials. It is necessary to design and execute bioassays to reduce variability as much as possible whilst enabling statistically valid measures of the reproducibility of potency estimates. The manuscripts in this volume aim to describe statistical approaches currently being used in the design and analysis of potency assays for biotechnology products, and to identify factors influencing the appropriate choice of these approaches. Issues that impact on assay design, implementation, validation and interpretation are discussed, both from the analysts and statisticians perspective.
Biological Characterization and Assay of Cytokines and Growth Factors
Cytokines and growth factors have vast therapeutic potentials for a wide range of diseases. Many have been cloned and produced, using recombinant DNA technology, by the biopharmaceutical industry. Of these, several have proved to be extremely successful biological medicines with increasing numbers undergoing clinical trials. One aspect of the successful development of these proteins as therapeutics is assuring quality control. This can mainly be achieved through thorough characterization of the product, both biologically and physico-chemically. In this book, leading scientists from industry, research and regulatory agencies present papers on the various methods currently available for analyz...
Biologics 2000
Reviews current scientific developments and regulatory issues relating to establishing comparability of biological products when manufactured within a single company or jointly with other companies.
Cancer FAX Directory
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State of the Art Analytical Methods for the Characterization of Biological Products and Assessment of Comparability
With the latest advances in analytical technologies, most biological products can now be extensively characterized in terms of their identity, heterogeneity and impurity profile. The currently available analytical methods (both physicochemical and biological) can characterize the primary, secondary and to some extent, the higher order structure of proteins. The sensitivity and selectivity of these methods allow for the identification and characterization not only of the desired protein component, but also many product-related substances and impurities as well as process-related impurities present in the drug preparations. Using an appropriate selection of analytical tools, it may be possible to demonstrate physicochemical and functional comparability between protein products manufactured before and after a manufacturing change or during product development. However, the extent of demonstrable comparability depends on the tests used, on the nature of the product and on the basic understanding of structure-function relationships. Assessment of immunogenicity is also a critical component of product characterization and is highly dependent on the types of assays used.
