UMBC Biotechnology at Shady Grove
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Item A-VAX: Applying Quality by Design to Vaccines(CASSS, 2012-05) CMC Vaccines Working Group Consortium; Schenerman, MarkItem A–Mab: A Case Study in Bioprocess Development(ISPE, 2009-10-30) Phillips, Joseph; Ericson, Lisa; Karunatilake, Chulani; Schenerman, Mark; et alThis is a detailed case study to stimulate discussion around how the core principles contained in Q8(R2), Q9 and Q10 guidelines could be applied to product realisation programs for a biotechnology-derived monoclonal antibody.Item The Roles of Bioactivity Assays in Lot Release and Stability Testing(BioProcess International, 2010-06) Rieder, Noel; Gazzano-Santoro, Hélène; Schenerman, Mark; Strause, Robert; Fuchs, Chana; Mire-Sluis, Anthony; McLeod, Lorna D.