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Development and Validation of RPH-104 Quantification Method in Blood Serum as a Tool for Personalization of Pharmacotherapy

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Pharmaceutical Chemistry Journal Aims and scope

Amethod for quantitative determination of the innovative recombinant heterodimeric protein RPH-104 in human blood serum by enzyme immunoassay (ELISA) was developed. The method was validated in terms of minimum required dilution (MRD), selectivity, calibration curve and sensitivity, accuracy and precision (within a cycle and between cycles), dilution linearity, specificity, and stability. The MRD was 1:100; sensitivity of the technique, 10 ng/mL (with allowance for the MRD). The validated method could be recommended for RPH-104 quantification in patient blood serum to personalize the efficacy of pharmacotherapy and to monitor treatment.

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Authors and Affiliations

  1. LLC Center of Pharmaceutical Analytics, 20/3 Nauchnyi Proezd, Moscow, 117246, Russia

    M. A. Kolganova, E. N. Fisher, N. V. Gorpinchenko, O. V. Saltykova & I. E. Shokhin

  2. I. M. Sechenov Moscow State Medical University (Sechenov University), Ministry of Health of the Russian Federation, 8/2 Trubetskaya St, Moscow, 119991, Russia

    E. V. Melnik, E. N. Fisher, V. I. Gegechkori, A. A. Zamyatnin, D. O. Neymysheva & G. V. Ramenskaya

Authors
  1. M. A. Kolganova
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  2. E. V. Melnik
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  3. E. N. Fisher
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  4. V. I. Gegechkori
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  5. A. A. Zamyatnin
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  6. D. O. Neymysheva
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  7. N. V. Gorpinchenko
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  8. O. V. Saltykova
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  9. I. E. Shokhin
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  10. G. V. Ramenskaya
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Corresponding author

Correspondence to V. I. Gegechkori.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 56, No. 12, pp. 66 – 70, December, 2022.

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Kolganova, M.A., Melnik, E.V., Fisher, E.N. et al. Development and Validation of RPH-104 Quantification Method in Blood Serum as a Tool for Personalization of Pharmacotherapy. Pharm Chem J 56, 1677–1681 (2023). https://doi.org/10.1007/s11094-023-02843-y

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  • DOI: https://doi.org/10.1007/s11094-023-02843-y

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