000			03307cam a2200337 a 4500
001			17709376
005			20220527085911.0
008			130422s2014 njua b 001 0 eng
010			_a 2013016301
020			_a9781118148891 (cloth)
035			_a(DNLM)101606602
040			_aDNLM/DLC _cDLC _dDLC
042			_apcc
050	0	0	_aRM301.25 _b.B57 2014
060	1	0	_aQV 241
082	0	0	_a615.19 _222
245	0	0	_aBiological drug products: development and strategies _cedited by Wei Wang, Manmohan Singh
260			_aHoboken, N.J. : _bWiley, _cc2014.
300			_axv, 728 p. : _bill. ; _c25 cm.
504			_aIncludes bibliographical references and index.
505	0		_aAn overview of discovery and development process for biologics / Heather H. Shih, Paula Miller, Douglas C. Harnish -- Nonclinical safety assessment of biologics, including vaccines / Liangbiao George Hu, David W. Clarke -- Clinical assessment of biologics agents / Lesley Ann Saketkoo, Shikha Mittoo, Luis R. Espinoza -- Key regulatory guidelines for development of biologics in the U.S. and Europe / Richard Kingham, Gabriela Klasa, Krista Hessler Carver -- Landscape and consideration of intellectual property for development of biosimilars / Srikumaran Melethil -- Scientific aspects of sterility assurance, sterility, asepsis, and sterilization / James E. Akers and James P. Agalloco -- Cell cell culture processes in monoclonal antibody production / Feng Li, Amy (Yijuan) Shen, Ashraf Amanullah -- Protein/peptide purification and virus reduction / Beckley K. Nfor, Esteban Freydell, and Marcel Ottens -- Chemical and genetic modification / M Farys ... [et al.] -- Analytical characterization of proteins/peptides / Yajun Jennifer Wang and Brian Hosken -- Protein/peptide formulation development / Satoshi Ohtake and Wei Wang -- Regulatory strategies and lessons in the development of biosimilars / Umang S. Shah -- Vaccine development : history, current status, and future trends / Leo Van Der Pol, Jean-Pierre Amorij -- Role and application of adjuvants and delivery systems in vaccines / Rajesh K. Gupta -- Methods for characterizing proteins in aluminum adjuvant formulations / Martinus A.H. Capelle, Emilie Poirier, Tudor Arvinte -- The state of the art and future of gene medicines / Frank Jacobs, Stephanie C. Gordts, Bart De Geest -- Nucleic acid vaccines / Rachel Buglione-Corbett ... [et al.] -- Multifunctional polymeric nano-systems for RNA interference therapy / Arun Iyer ... [et al.] -- Advent and maturation of regenerative medicine / Abner M. Mhashilkar, Anthony Atala -- Conventional and novel container closure/delivery systems / Joseph Wong, Mahesh V. Chaubal -- Controlled-release systems for biologics / Mayura Oak ... [et al.] -- Routes of delivery for biological drug products / Darrell J. Irvine, Xingfang Su, Brandon Kwong.
650	1	2	_aBiological Agents _xpharmacology.
650	1	2	_aBiological Agents _xtherapeutic use.
650	2	2	_aDrug Delivery Systems.
650	2	2	_aDrug Discovery.
700	1		_aWang, Wei, _d1957 March 10-
700	1		_aManmohan Singh, _d1964 November 8-
776	0	8	_iOnline version: _tBiological drug products _dHoboken, N.J. : John Wiley & Sons, c2014 _z9781118695036 _w(DLC) 2013016910
906			_a7 _bcbc _corignew _d1 _eecip _f20 _gy-gencatlg
942			_2ddc _cBK
999			_c9912 _d9912