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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Li, Yi Stella, Cinzia Zheng, Laura Bechtel, Charity Gruenhagen, Jason Jacobson, Fred Medley, Colin D. |
| Description | Country affiliation: United States Author Affiliation: Li Y ( Small Molecule Pharmaceutical Sciences, Genentech, South San Francisco, CA 94080, United States.); Stella C ( Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, United States.); Zheng L ( Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, United States.); Bechtel C ( Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, United States.); Gruenhagen J ( Small Molecule Pharmaceutical Sciences, Genentech, South San Francisco, CA 94080, United States.); Jacobson F ( Protein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, United States.); Medley CD ( Small Molecule Pharmaceutical Sciences, Genentech, South San Francisco, CA 94080, United States. Electronic address: medley.colin@gene.com.) |
| Abstract | Antibody drug conjugates (ADCs) are complex therapeutic agents combining the selectivity of monoclonal antibodies and highly efficacious small molecule drugs to successfully eliminate tumor cells while limiting the general toxicity and side effects of the therapeutic to protect patient safety. One unique attribute critical to the safety of ADCs is the residual content of unconjugated small molecule drug present from either incomplete conjugation or degradation of the ADC. Typically for quality control assays, quantifying the amount of the free drug is performed through precipitation of the protein species using an organic solvent and then assaying the amount of free drug left in the supernatant. During the validation of an assay of this type for a maleimide based linker drug, issues were experienced with low and variable recovery in the spiked samples of the drug substance and drug product. A two-dimensional heart-cutting method coupling Size Exclusion Chromatography (SEC) with Reverse Phase (RP) chromatography was utilized to explore possible mechanisms leading to the low recovery of the free linker drug. The results of the investigation indicated that the spiked linker drug reacts with residual reactive groups on the ADC; a conclusion which was confirmed by the observed increase of average Drug to Antibody Ratio (DAR) determined by Hydrophobic Interaction Chromatography (HIC). Finally, several approaches were evaluated to minimize the recovery loss. Capping the residual reactive groups on the ADC with maleimide containing reagents effectively mitigated the low recovery issue. |
| File Format | HTM / HTML |
| ISSN | 15700232 |
| Journal | Journal of Chromatography B |
| Volume Number | 1032 |
| e-ISSN | 1873376X |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2016-10-01 |
| Publisher Place | Netherlands |
| Access Restriction | One Nation One Subscription (ONOS) |
| Content Type | Text |
| Resource Type | Article |
| Subject | Cell Biology Medicine Analytical Chemistry Clinical Biochemistry Biochemistry |
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