Literature DB >> 9181460

Points to consider in the manufacture and testing of monoclonal antibody products for human use (1997). U.S. Food and Drug Administration Center for Biologics Evaluation and Research.

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Year:  1997        PMID： 9181460     DOI： 10.1097/00002371-199705000-00007

Source DB:  PubMed          Journal:  J Immunother        ISSN： 1524-9557            Impact factor:   4.456


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  52 in total

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Review 4.  The present state of the art in expression, production and characterization of monoclonal antibodies.

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Review 5.  Practical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies.

Authors:  Carmel M Lynch; Bruce W Hart; Iqbal S Grewal
Journal:  MAbs       Date:  2009 Jan-Feb       Impact factor: 5.857

Review 6.  Bridging the gap: facilities and technologies for development of early stage therapeutic mAb candidates.

Authors:  Trent P Munro; Stephen M Mahler; Edwin P Huang; David Y Chin; Peter P Gray
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7.  Species-Specific Involvement of Integrin αIIbβ3 in a Monoclonal Antibody CH12 Triggers Off-Target Thrombocytopenia in Cynomolgus Monkeys.

Authors:  Yiting Zhang; Jianhua Sun; Minjia Tan; Yongzhen Liu; Qian Li; Hua Jiang; Huamao Wang; Zonghai Li; Wei Wan; Hualiang Jiang; Henglei Lu; Bingshun Wang; Jin Ren; Likun Gong
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8.  Recurring genomic structural variation leads to clonal instability and loss of productivity.

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9.  A pilot study: 131I-antitenascin monoclonal antibody 81c6 to deliver a 44-Gy resection cavity boost.

Authors:  David A Reardon; Michael R Zalutsky; Gamal Akabani; R Edward Coleman; Allan H Friedman; James E Herndon; Roger E McLendon; Charles N Pegram; Jennifer A Quinn; Jeremy N Rich; James J Vredenburgh; Annick Desjardins; Sridharan Guruangan; Susan Boulton; Renee H Raynor; Jeanette M Dowell; Terence Z Wong; Xiao-Guang Zhao; Henry S Friedman; Darell D Bigner
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10.  Filter preconditioning enables representative scaled-down modelling of filter capacity and viral clearance by mitigating the impact of virus spike impurities.

Authors:  Navid Z Khan; Joseph J Parrella; Paul W Genest; Michael S Colman
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