{"product_id":"therapeutic-protein-drug-products-practical-approaches-to-formulation-in-the-laboratory-manufacturing-and-the-clinic-hardback-9781907568183","title":"Therapeutic Protein Drug Products; Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic (Hardback) 9781907568183","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eTherapeutic Protein Drug Products\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003ePractical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eBrian K Meyer (Edited by)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9781907568183, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 2 January 2012\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e200 pages\u003cbr\u003e23.4 x 15.6 x 2 cm, 0.48 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003eTherapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed.\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003eList of figures and tables\u003c\/p\u003e \u003cp\u003ePreface\u003c\/p\u003e \u003cp\u003eAbout the authors\u003c\/p\u003e \u003cp\u003eChapter 1: Commercial therapeutic protein drug products\u003c\/p\u003e \u003cp\u003eAbstract\u003c\/p\u003e \u003cp\u003e1.1 Introduction\u003c\/p\u003e \u003cp\u003e1.2 Lyophilized formulations\u003c\/p\u003e \u003cp\u003e1.3 Liquid formulations\u003c\/p\u003e \u003cp\u003e1.4 Protein formulations for radiologic and diagnostic use\u003c\/p\u003e \u003cp\u003e1.5 Summary\u003c\/p\u003e \u003cp\u003eChapter 2: A formulation method to improve the physical stability of macromolecular-based drug products\u003c\/p\u003e \u003cp\u003eAbstract\u003c\/p\u003e \u003cp\u003e2.1 Introduction\u003c\/p\u003e \u003cp\u003e2.2 Common techniques used for the construction of EPDs\u003c\/p\u003e \u003cp\u003e2.3 The peptide drug pramlintide\u003c\/p\u003e \u003cp\u003e2.4 Monoclonal antibodies at low and high concentration\u003c\/p\u003e \u003cp\u003e2.5 Static vs. dynamic EPDs: a case study using a humanized immunoglobulin (IgG1)\u003c\/p\u003e \u003cp\u003e2.6 Conclusion and future studies\u003c\/p\u003e \u003cp\u003eChapter 3: Properties of protein formulations\u003c\/p\u003e \u003cp\u003eAbstract\u003c\/p\u003e \u003cp\u003e3.1 Introduction\u003c\/p\u003e \u003cp\u003e3.2 Opalescence\u003c\/p\u003e \u003cp\u003e3.3 Phase separation\u003c\/p\u003e \u003cp\u003e3.4 Color\u003c\/p\u003e \u003cp\u003e3.5 Subvisible particles\u003c\/p\u003e \u003cp\u003eChapter 4: Material and process compatibility testing\u003c\/p\u003e \u003cp\u003eAbstract\u003c\/p\u003e \u003cp\u003e4.1 Introduction\u003c\/p\u003e \u003cp\u003e4.2 Material compatibility\u003c\/p\u003e \u003cp\u003e4.3 Process compatibility testing\u003c\/p\u003e \u003cp\u003e4.4 Antimicrobial preservative compatibility testing\u003c\/p\u003e \u003cp\u003eChapter 5: Compounding and filling: drug substance to drug product\u003c\/p\u003e \u003cp\u003eAbstract\u003c\/p\u003e \u003cp\u003e5.1 Introduction\u003c\/p\u003e \u003cp\u003e5.2 Aseptic processing\u003c\/p\u003e \u003cp\u003e5.3 Bulk drug substance\u003c\/p\u003e \u003cp\u003e5.4 Compounding of drug product\u003c\/p\u003e \u003cp\u003e5.5 Filling the drug product\u003c\/p\u003e \u003cp\u003eChapter 6: Administration in the clinic\u003c\/p\u003e \u003cp\u003eAbstract\u003c\/p\u003e \u003cp\u003e6.1 Introduction and background\u003c\/p\u003e \u003cp\u003e6.2 Diluents\u003c\/p\u003e \u003cp\u003e6.3 Components\u003c\/p\u003e \u003cp\u003e6.4 Construction materials\u003c\/p\u003e \u003cp\u003e6.5 Clinical dosing strategy: fixed volume versus fixed concentration\u003c\/p\u003e \u003cp\u003e6.6 Representative admixture concentration levels\u003c\/p\u003e \u003cp\u003e6.7 Exposure temperature and time\u003c\/p\u003e \u003cp\u003e6.8 Option of using syringes\u003c\/p\u003e \u003cp\u003e6.9 Analytical tests and acceptance criteria\u003c\/p\u003e \u003cp\u003e6.10 Sample preparation considerations\u003c\/p\u003e \u003cp\u003e6.11 Role of probe studies\u003c\/p\u003e \u003cp\u003e6.12 Bag overfill volume\u003c\/p\u003e \u003cp\u003e6.13 Pharmacy instructions\u003c\/p\u003e \u003cp\u003e6.14 Conclusions\u003c\/p\u003e \u003cp\u003eChapter 7: Regulatory guidelines for the development of a biotechnology drug product\u003c\/p\u003e \u003cp\u003eAbstract\u003c\/p\u003e \u003cp\u003e7.1 Introduction\u003c\/p\u003e \u003cp\u003e7.2 ICH overview\u003c\/p\u003e \u003cp\u003e7.3 Common Technical Document (CTD)\u003c\/p\u003e \u003cp\u003e7.4 Drug product dossier\u003c\/p\u003e \u003cp\u003e7.5 Regulatory considerations through the biotechnology product lifecycle\u003c\/p\u003e \u003cp\u003e7.6 Conclusions\u003c\/p\u003e \u003cp\u003eAppendix\u003c\/p\u003e \u003cp\u003eRecommended reading\u003c\/p\u003e \u003cp\u003eIndex\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Pharmacology [\u003ca title=\"See our other books on Pharmacology\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmacology%20%5BMMG%5D%22\"\u003eMMG\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Woodhead Publishing","offers":[{"title":"Default Title","offer_id":46651783708952,"sku":"9781907568183","price":89.79,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/products\/9781907568183.jpg?v=1696598750","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/therapeutic-protein-drug-products-practical-approaches-to-formulation-in-the-laboratory-manufacturing-and-the-clinic-hardback-9781907568183","provider":"Freshly Printed Books","version":"1.0","type":"link"}