【序号】:1
【作者】:Alexandre Ambrogelly Biologics Analytical Operations, Pharmaceutical & Biologics Development, Gilead Sciences, Ocean Ranch Blvd, Oceanside, CA, Stephen Gozo Analytical Research & Development-Biologics, Celgene Corporation, Morris Avenue, Summit, NJ, Amit Katiyar Analytical Development, Bristol-Myers Squibb, Pennington Rocky Road, Pennington, NJ, Shara Dellatore Biologics & Vaccines Bioanalytics, MRL, Merck & Co., Inc., Galloping Hill Road, Kenilworth, NJ USA, Yune Kune Fortress Biologicals, Sawyer Road, Suite, Waltham, MA, Ram Bhat【题名】:Analytical comparability study of recombinant monoclonal antibody therapeutics
【期刊】:mAbs Volume 10, 2018 - Issue 4
【年、卷、期、起止页码】:Pages 513-538
【全文链接】:https://www.tandfonline.com/doi/pdf/10.1080/19420862.2018.1438797?redirect=1
【序号】:2
【作者】:Cheng Du,Yunping Huang, Ameya Borwankar, Zhijun Tan,
【题名】:Using hydrogen peroxide to prevent antibody disulfide bond reduction during manufacturing process
【期刊】:mAbs
Volume 10, 2018 - Issue 3
【年、卷、期、起止页码】:Pages 500-510
【全文链接】:https://www.ncbi.nlm.nih.gov/pubmed/23506207
【序号】:3
【作者】:Neh Nupur, Nidhi Chhabra, Rozaleen Dash & Anurag S. Rathore
【题名】:Assessment of structural and functional similarity of biosimilar products: Rituximab as a case study
【期刊】:mAbs
Volume 10, 2018 - Issue 1
【年、卷、期、起止页码】:Pages 143-158
【全文链接】:https://www.tandfonline.com/doi/full/10.1080/19420862.2017.1402996
【序号】:4
【作者】:Brian Hassett, Ena Singh, Ehab Mahgoub, Julie O'Brien, Steven M. Vicik & Brian Fitzpatrick
【题名】:Manufacturing history of etanercept (Enbrel®): Consistency of product quality through major process revisions
【期刊】:mAbs
Volume 10, 2018 - Issue 1
【年、卷、期、起止页码】:Pages 159-165
【全文链接】:https://www.tandfonline.com/doi/full/10.1080/19420862.2017.1388483
【序号】:5
【作者】:Brian Hassett, Morton Scheinberg, Gilberto Castañeda-Hernández
【题名】:Variability of intended copies for etanercept (Enbrel®): Data on multiple batches of seven products
【期刊】:mAbs Volume 10, 2018 - Issue 1
【年、卷、期、起止页码】:Pages 166-176
【全文链接】:https://www.tandfonline.com/doi/full/10.1080/19420862.2017.1387346