Search Results - "De Felippis, Michael R"

A Novel Sample Preparation for Shotgun Proteomics Characterization of HCPs in Antibodies by Huang, Lihua, Wang, Ning, Mitchell, Charles E, Brownlee, Tammy, Maple, Steven R, De Felippis, Michael R

“…Residual host cell proteins (HCPs) in biopharmaceuticals derived from recombinant DNA technology can present potential safety risks to patients or compromise…”
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Endotoxin recovery using limulus amebocyte lysate (LAL) assay by Bolden, Jay S., Warburton, Rob E., Phelan, Robert, Murphy, Marie, Smith, Kelly R., De Felippis, Michael R., Chen, Dayue

“…A phenomenon initially reported by Chen and Vinther in 2013 [1], and now commonly referred to as low endotoxin recovery (LER), has prompted the Food and Drug…”
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Identification of Racemization Sites Using Deuterium Labeling and Tandem Mass Spectrometry by Huang, Lihua, Lu, Xiaojun, Gough, P. Clayton, De Felippis, Michael R

“…Racemization of amino acids is a common chemical degradation pathway observed in biopharmaceuticals and is particularly prevalent in synthetic peptides. The…”
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Subcutaneous Injection Site Pain of Formulation Matrices by Shi, Galen H., Pisupati, Karthik, Parker, Jonathan G., Corvari, Vincent J., Payne, Christopher D., Xu, Wen, Collins, David S., De Felippis, Michael R.

“…Purpose The objective of this work was to systematically evaluate the effects of formulation composition on subcutaneous injection site pain (ISP) using…”
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Method for Characterization of PEGylated Bioproducts in Biological Matrixes by Liu, Qingyuan, De Felippis, Michael R., Huang, Lihua

“…PEGylation of peptides and proteins has been widely used to enhance stability and reduce immunogenicity of biotherapeutics. Characterizing the degradation of…”
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How long should insulin be used once a vial is started? by GRAJOWER, Martin M, FRASER, Charles G, HOLCOMBE, John H, DAUGHERTY, Marci L, HARRIS, William C, DE FELIPPIS, Michael R, SANTIAGO, Olga M, CLARK, Nathaniel G

“…Grajower et al examine the potency of opened and refrigerated human insulin vials. The stability of human insulin vials is dependent upon a number of factors…”
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Non-native intermediate conformational states of human growth hormone in the presence of organic solvents by Sukumar, Muppalla, Storms, Sacha M, De Felippis, Michael R

“…Manufacturing processes expose protein pharmaceuticals to organic solvents that may perturb the native folded state, increasing the potential for irreversible…”
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How Long Should Insulin Be Used Once a Vial Is Started? by Holcombe, John H., Daugherty, Marci L., De Felippis, Michael R.

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How long should insulin be used once a vial is started? Response to Molitch by Holcombe, John H, Daugherty, Marci L, De Felippis, Michael R

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How long should insulin be used once a vial is started? Response to Grajower et al by Molitch, Mark E

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