Are Biotransformation Studies of Therapeutic Proteins Needed? Scientific Considerations and Technical Challenges
Schadt, Simone, Hauri, Simon, Lopes, Filipe, Edelmann, Martin R, Staack, Roland F, Villaseñor, Roberto, Kettenberger, Hubert, Roth, Adrian B, Schuler, Franz, Richter, Wolfgang F, Funk, Christoph
Published in Drug metabolism and disposition (01.12.2019)
Published in Drug metabolism and disposition (01.12.2019)
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Generation, Characterization, and Quantitative Bioanalysis of Drug/Anti-drug Antibody Immune Complexes to Facilitate Dedicated In Vivo Studies
Hoffmann, Eugenia, Jordan, Gregor, Lauer, Matthias, Ringler, Philippe, Kusznir, Eric A., Rufer, Arne C., Huber, Sylwia, Jochner, Anton, Winter, Gerhard, Staack, Roland F.
Published in Pharmaceutical research (01.09.2019)
Published in Pharmaceutical research (01.09.2019)
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Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution
Opolka-Hoffmann, Eugenia, Edelmann, Martin R., Otteneder, Michael B., Hauri, Simon, Jordan, Gregor, Schrag, Peter, Lechmann, Martin, Winter, Gerhard, Staack, Roland F.
Published in The AAPS journal (13.03.2024)
Published in The AAPS journal (13.03.2024)
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Journal Article
Validation of a method to analyze size distribution of crovalimab-complement C5–eculizumab complexes in human serum
Nishidate, Masanobu, Shibahara, Norihito, Hayasaka, Akira, Staack, Roland F, Miyayama, Takashi, Terao, Kimio, Jordan, Gregor
Published in Bioanalysis (01.07.2022)
Published in Bioanalysis (01.07.2022)
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Journal Article
The impact of immunogenicity on therapeutic antibody pharmacokinetics: A preclinical evaluation of the effect of immune complex formation and antibody effector function on clearance
Opolka-Hoffmann, Eugenia, Jordan, Gregor, Otteneder, Michael, Kieferle, Robin, Lechmann, Martin, Winter, Gerhard, Staack, Roland F.
Published in mAbs (01.01.2021)
Published in mAbs (01.01.2021)
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Journal Article
High ionic strength dissociation assay (HISDA) for high drug tolerant immunogenicity testing
Jordan, Gregor, Pöhler, Alexander, Guilhot, Florence, Zaspel, Meike, Staack, Roland F
Published in Bioanalysis (01.06.2020)
Published in Bioanalysis (01.06.2020)
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Journal Article
In Vivo Biotransformation of the Fusion Protein Tetranectin-Apolipoprotein A1 Analyzed by Ligand-Binding Mass Spectrometry Combined with Quantitation by ELISA
Zell, Manfred, Husser, Christophe, Staack, Roland F, Jordan, Gregor, Richter, Wolfgang F, Schadt, Simone, Pähler, Axel
Published in Analytical chemistry (Washington) (06.12.2016)
Published in Analytical chemistry (Washington) (06.12.2016)
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Journal Article
Analysis of erlotinib and its metabolites in rat tissue sections by MALDI quadrupole time-of-flight mass spectrometry
Signor, Luca, Varesio, Emmanuel, Staack, Roland F., Starke, Volkmar, Richter, Wolfgang F., Hopfgartner, Gérard
Published in Journal of mass spectrometry. (01.07.2007)
Published in Journal of mass spectrometry. (01.07.2007)
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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)
Piccoli, Steven, Mehta, Devangi, Vitaliti, Alessandra, Allinson, John, Amur, Shashi, Eck, Steve, Green, Cherie, Hedrick, Michael, Hopper, Shirley, Ji, Allena, Joyce, Alison, Litwin, Virginia, Maher, Kevin, Mathews, Joel, Peng, Kun, Safavi, Afshin, Wang, Yow-Ming, Zhang, Yan, Amaravadi, Lakshmi, Palackal, Nisha, Thankamony, Sai, Beaver, Chris, Bame, Eris, Emrich, Thomas, Grimaldi, Christine, Haulenbeek, Jonathan, Kakkanaiah, Vellalore, Lanham, David, Mayer, Andrew, Trampont, Paul C, Vermet, Laurent, Dakappagari, Naveen, Fleener, Catherine, Garofolo, Fabio, Rogers, Cynthia, Tangri, Shabnam, Xu, Yuanxin, Liang, Meina, Rajadhyaksha, Manoj, Richards, Susan, Schweighardt, Becky, Purushothama, Shobha, Baltrukonis, Daniel, Brumm, Jochen, Cherry, Elana, Delcarpini, Jason, Gleason, Carol, Kirshner, Susan, Kubiak, Robert, Pan, Luying, Partridge, Michael, Pedras-Vasconcelos, João, Qu, Qiang, Skibeli, Venke, Saunders, Therese Solstad, Staack, Roland F, Stubenrauch, Kay, Torri, Al, Verthelyi, Daniela, Yan, Haoheng, Gorovits, Boris, Palmer, Rachel, Milton, Mark, Long, Brian, Corsaro, Bart, Farrokhi, Vahid, Fiscella, Michele, Henderson, Neil, Jawa, Vibha, McNally, Jim, Murphy, Rocio, Waldner, Hanspeter, Yang, Tong-Yuan
Published in Bioanalysis (01.12.2019)
Published in Bioanalysis (01.12.2019)
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Phase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure
Spreafico, Anna, Couselo, Eva Muñoz, Irmisch, Anja, Bessa, Juliana, Au-Yeung, George, Bechter, Oliver, Svane, Inge Marie, Sanmamed, Miguel F, Gambardella, Valentina, McKean, Meredith, Callahan, Margaret, Dummer, Reinhard, Klein, Christian, Umaña, Pablo, Justies, Nicole, Heil, Florian, Fahrni, Linda, Opolka-Hoffmann, Eugenia, Waldhauer, Inja, Bleul, Conrad, Staack, Roland F, Karanikas, Vaios, Fowler, Stephen
Published in Frontiers in oncology (21.03.2024)
Published in Frontiers in oncology (21.03.2024)
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Journal Article
Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline
Timmerman, Philip, Barfield, Matthew, Cowan, Kyra, Ferrari, Luca, Golob, Michaela, Goodman, Joanne, Kall, Morten, Laurén, Anna, Love, Iain, McDougall, Stuart, Nelson, Robert, Pynaert, Gwenda, Staack, Roland F, Verhaeghe, Tom, White, Steve
Published in Bioanalysis (01.11.2022)
Published in Bioanalysis (01.11.2022)
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Journal Article
Increasing robustness, reliability and storage stability of critical reagents by freeze-drying
Emrich, Thomas, Stracke, Jan Olaf, Guo, Xiaoying, Damhjell, Kari, Moelleken, Joerg, Vogel, Rudolf, Stubenrauch, Kay-Gunnar, Staack, Roland F
Published in Bioanalysis (01.05.2021)
Published in Bioanalysis (01.05.2021)
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