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PDA Journal of Pharmaceutical Science and Technology|January 17, 2017
Mycoplasma Clearance and Risk Analysis in a Model BioprocessJulie Wang, Sarah Johnson, Matthew Brown, et al.Biotechnology Progress|May 11, 2016
Mechanistic failure mode investigation and resolution of parvovirus retentive filtersDaniel LaCasse, Scott Lute, Marcus Fiadeiro, et al.Annals of the New York Academy of Sciences|December 1, 2012
Scientific considerations for complex drugs in light of established and emerging regulatory guidanceChris Holloway, Jan Mueller-Berghaus, Beatriz Silva Lima, et al.Carbohydrate Polymers|February 20, 2020
In-depth structural characterization of pentosan polysulfate sodium complex drug using orthogonal analytical toolsAnna Alekseeva, Rahul Raman, Giorgio Eisele, et al.Applied and Environmental Microbiology|August 6, 2004
Characterization of coliphage PR772 and evaluation of its use for virus filter performance testingScott Lute, Hazel Aranha, Denise Tremblay, et al.Journal of Pharmaceutical and Biomedical Analysis|September 19, 2018
An ICP-MS platform for metal content assessment of cell culture media and evaluation of spikes in metal concentration on the quality of an IgG3:κ monoclonal antibody during productionAdil Mohammad, Cyrus Agarabi, Sarah Rogstad, et al.Journal of Chromatography. A|April 23, 2005
Impact of multiple re-use of anion-exchange chromatography media on virus removalLenore Norling, Scott Lute, Rachel Emery, et al.Journal of Chromatography. A|August 30, 2008
Robustness of virus removal by protein A chromatography is independent of media lifetimeScott Lute, Lenore Norling, Michael Hanson, et al.Biotechnology and Bioengineering|October 25, 2017
Comparison of purification strategies for antibodies used in a broad spectrum host cell protein immunoassayPhoebe A Baldus, Matthew Brown, Richard S Wright, et al.Biologicals : Journal of the International Association of Biological Standardization|February 16, 2002
Evaluation of a quantitative product-enhanced reverse transcriptase assay to monitor retrovirus in mAb cell-cultureKurt Brorson, Yuan Xu, Patrick G Swann, et al.Pageof 6