Search Results - "Ivens, Inge A."

PEGylation of Biopharmaceuticals: A Review of Chemistry and Nonclinical Safety Information of Approved Drugs by Turecek, Peter L, Bossard, Mary J, Schoetens, Freddy, Ivens, Inge A

“…Modification of biopharmaceutical molecules by covalent conjugation of polyethylene glycol (PEG) molecules is known to enhance pharmacologic and pharmaceutical…”
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Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies by Ponce, Rafael, Abad, Leslie, Amaravadi, Lakshmi, Gelzleichter, Thomas, Gore, Elizabeth, Green, James, Gupta, Shalini, Herzyk, Danuta, Hurst, Christopher, Ivens, Inge A., Kawabata, Thomas, Maier, Curtis, Mounho, Barbara, Rup, Bonita, Shankar, Gopi, Smith, Holly, Thomas, Peter, Wierda, Dan

“…An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile…”
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PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development by Ivens, Inge A., Achanzar, William, Baumann, Andreas, Brändli-Baiocco, Annamaria, Cavagnaro, Joy, Dempster, Maggie, Depelchin, B. Olympe, Irizarry Rovira, Armando R., Dill-Morton, Laura, Lane, Joan H., Reipert, Birgit M., Salcedo, Theodora, Schweighardt, Becky, Tsuruda, Laurie S., Turecek, Peter L., Sims, Jennifer

“…PEGylation (the covalent binding of one or more polyethylene glycol molecules to another molecule) is a technology frequently used to improve the half-life and…”
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Nonclinical Safety Assessment of a Long-Acting Recombinant PEGylated Factor Eight (BAY 94-9027) With a 60 kDa PEG by Ivens, Inge A., Banczyk, David, Gutberlet, Katrin, Jackman, Shawna, Vauléon, Stéphanie, Frisk, Anna-Lena

“…BAY 94-9027 (Jivi) is a site-specifically PEGylated human B-domain-deleted (BDD) recombinant factor VIII (FVIII), with a 60 kDa branched PEG molecule attached…”
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Subcutaneous administration of biotherapeutics: current experience in animal models by McDonald, Thomas A, Zepeda, Monica L, Tomlinson, Michael J, Bee, Walter H, Ivens, Inge A

“…In recent years, many peptide- and protein-based biotherapeutics have been approved for subcutaneous (SC) delivery. The mechanisms and factors affecting the…”
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BAY 94–9027, a PEGylated Recombinant Human FVIII, Shows Less Immunogenicity Compared to Un-PEGylated Recombinant FVIII by Ivens, Inge A, Zierz, Ruprecht, Haaning, Jesper, McDonald, Thomas

“…Abstract 2214 BAY 94–9027, a recombinant FVIII candidate containing a single, large, branched polyethylene glycol (PEG) molecule conjugated to a specific amino…”
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