Research ArticleArticle
Are Biotransformation Studies of Therapeutic Proteins Needed? Scientific Considerations and Technical Challenges
Simone Schadt, Simon Hauri, Filipe Lopes, Martin R. Edelmann, Roland F. Staack, Roberto Villaseñor, Hubert Kettenberger, Adrian B. Roth, Franz Schuler, Wolfgang F. Richter and Christoph Funk
Drug Metabolism and Disposition December 2019, 47 (12) 1443-1456; DOI: https://doi.org/10.1124/dmd.119.088997
Simone Schadt
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
Simon Hauri
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
Filipe Lopes
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
Martin R. Edelmann
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
Roland F. Staack
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
Roberto Villaseñor
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
Hubert Kettenberger
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
Adrian B. Roth
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
Franz Schuler
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
Wolfgang F. Richter
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
Christoph Funk
Roche Pharma Research and Early Development, Pharmaceutical Sciences (S.S., S.H., F.L., R.V., A.B.R., F.S., W.F.R., C.F.) and Roche Pharma Research and Early Development, Therapeutic Modalities (M.R.E.), Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland; and Roche Pharma Research and Early Development, Pharmaceutical Sciences (R.F.S.) and Roche Pharma Research and Early Development, Therapeutic Modalities (H.K.), Roche Innovation Center Munich, Roche Diagnostics, Penzberg, Germany
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In this issue
Research ArticleArticle
Therapeutic Protein Biotransformation
Simone Schadt, Simon Hauri, Filipe Lopes, Martin R. Edelmann, Roland F. Staack, Roberto Villaseñor, Hubert Kettenberger, Adrian B. Roth, Franz Schuler, Wolfgang F. Richter and Christoph Funk
Drug Metabolism and Disposition December 1, 2019, 47 (12) 1443-1456; DOI: https://doi.org/10.1124/dmd.119.088997
Research ArticleArticle
Therapeutic Protein Biotransformation
Simone Schadt, Simon Hauri, Filipe Lopes, Martin R. Edelmann, Roland F. Staack, Roberto Villaseñor, Hubert Kettenberger, Adrian B. Roth, Franz Schuler, Wolfgang F. Richter and Christoph Funk
Drug Metabolism and Disposition December 1, 2019, 47 (12) 1443-1456; DOI: https://doi.org/10.1124/dmd.119.088997
Jump to section
- Article
- Abstract
- Introduction
- Clearance Versus Biotransformation of Therapeutic Proteins
- Strategic Considerations
- Regulatory Considerations
- Technical Approaches To Study Therapeutic Protein Biotransformation
- Radiolabeling and Orthogonal Labeling Approaches
- Affinity Purification
- Separation
- HPLC Radiometric Detection
- Mass Spectrometry
- Sample Preparation to Facilitate MS Analysis
- Conclusions and Future Perspective
- Acknowledgments
- Authorship Contributions
- Footnotes
- Abbreviations
- References
- Figures & Data
- Info & Metrics
- eLetters
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