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UID:cbf48dbc-9632-40e9-bda1-e33c5617be9f.215807@calendar.missouristate.edu
CREATED:20210304T200738Z
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SUMMARY:Chemistry Seminar - Dr. Mary Krause
DESCRIPTION:High Concentration Formulation Development of Biologic Drug Pr
 oducts\n\n\nDr. Mary Krause\, an alumna of MSU\, is an associate scientif
 ic director in the drug product development department of Bristol Myers S
 quibb\, a global biopharmaceutical company. Her current research focuses 
 on physical and chemical degradation of proteins that can occur during de
 velopment and manufacturing\; in particular\, she is a subject matter exp
 ert on metal catalyzed oxidation of proteins.\n\n\nIn this presentation\,
  we will explore a case study where a formulation screening DoE approach 
 was applied to an Fc fusion protein to optimize the formulation for a hig
 h concentration drug product presentation for subcutaneous administration
 . The formulations that provided the most optimal stability profiles were
  then screened using small-scale tools to assess the impact of interfacia
 l and shear stresses present during drug product development. Combining f
 ormulation screening with formulation performance informed not only the s
 torage stability but also the processing operational space needed to main
 tain integrity of this unique protein drug product in different formulati
 ons.
X-ALT-DESC;FMTTYPE=text/html:&lt;html&gt;&lt;head&gt;&lt;title&gt;&lt;/title&gt;&lt;/head&gt;&lt;body&gt;&lt;p&gt;&lt;s
 trong&gt;High Concentration Formulation Development of Biologic Drug Product
 s&lt;/strong&gt;&lt;/p&gt;\n&lt;p&gt;Dr. Mary Krause\, an alumna of MSU\, is an associate s
 cientific director in the drug product development department of Bristol 
 Myers Squibb\, a global biopharmaceutical company. Her current research f
 ocuses on physical and chemical degradation of proteins that can occur du
 ring development and manufacturing\; in particular\, she is a subject mat
 ter expert on metal catalyzed oxidation of proteins.&lt;/p&gt;\n&lt;p&gt;In this pres
 entation\, we will explore a case study where a formulation screening DoE
  approach was applied to an Fc fusion protein to optimize the formulation
  for a high concentration drug product presentation for subcutaneous admi
 nistration. The formulations that provided the most optimal stability pro
 files were then screened using small-scale tools to assess the impact of 
 interfacial and shear stresses present during drug product development. C
 ombining formulation screening with formulation performance informed not 
 only the storage stability but also the processing operational space need
 ed to maintain integrity of this unique protein drug product in different
  formulations.&lt;/p&gt;&lt;/body&gt;&lt;/html&gt;
DTSTART;TZID=America/Chicago:20210310T153500
DTEND;TZID=America/Chicago:20210310T163500
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CATEGORIES:Public,Alumni,Current Students,Faculty,Future Students,Staff
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