Pharmacokinetics and Exposure–Response Relationship of Luspatercept in Patients with Anemia Due to Lower-Risk MDS: Preliminary Results from Phase 2 Studies

Chen, N.; Laadem, Abderrahmane; Wilson, Dorian; Zhang, X.; Sherman, Michael; Ritland, S; Attie, K M; Platzbecker, Uwe

doi:10.1016/s0145-2126(17)30190-x

Cited by 1 publication

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“…The validation results are summarized in Table 2. However, as several clinical trials indicate that the post-administration serum levels of both protein drugs can be much higher, [28][29][30] additional precautions should be taken for doping control routine analysis. The identification capability was successfully demonstrated at the LOD which was estimated as 50 ng/mL (S/N > 3).…”

Section: Methods Characterizationmentioning

confidence: 99%

Combined detection of the ActRII‐Fc fusion proteins Sotatercept (ActRIIA‐Fc) and Luspatercept (modified ActRIIB‐Fc) in serum by means of immunoaffinity purification, tryptic digestion, and LC‐MS/MS

Walpurgis

Thomas

Lange

et al. 2018

Drug Testing and Analysis

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Therapeutic proteins are a continuously growing class of pharmaceuticals and comprise several drug candidates with potential performance-enhancing properties. In particular, activin receptor competitors, such as the ActRII-Fc fusion proteins Sotatercept (ActRIIA-Fc) and Luspatercept (modified ActRIIB-Fc), have the potential for being misused as doping agents in sports as they were found to inhibit negative regulators of late-stage erythropoiesis.Within this study, ammonium sulfate precipitation, immunoaffinity purification, tryptic digestion, and liquid chromatography-tandem mass spectrometry (LC-MS/MS) were employed to develop an assay for the combined detection of Sotatercept and Luspatercept in doping control serum samples. The assay was optimized, comprehensively characterized, and found to be fit-for-purpose for application to sports drug testing. It complements existing tests for ActRII-Fc fusion proteins and expands the range of available detection methods for novel protein therapeutics.

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Section: Methods Characterizationmentioning

confidence: 99%