Email this article Development of a Pharmaceutical Composition and Stablity of Liquid Dosage Forms Based on Monoclonal IgG1 Antibodies
- Authors: Lomkova E.A.1, Shitikova V.O.1, Tsukur A.A.1,2, Sozonova A.A.1, Ryakhovskaya A.M.1
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Affiliations:
- BIOCAD Biotechnology Co.
- St. Petersburg State Chemical Pharmaceutical Academy
- Issue: Vol 53, No 8 (2019)
- Pages: 748-754
- Section: Drug Synthesis Methods and Manufacturing Technology
- URL: https://journals.rcsi.science/0091-150X/article/view/245980
- DOI: https://doi.org/10.1007/s11094-019-02073-1
- ID: 245980
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Abstract
A scheme for developing an excipient composition for liquid dosage forms based on monoclonal antibodies(mAbs) is proposed and used to develop a stable formulation of an active pharmaceutical ingredient (API) and finished dosage form (FDF) for s.c. injection of mAbs IgG1 against a tumor necrosis factor (TNF-α) with API concentrations from 50 to 150 mg/mL.
About the authors
E. A. Lomkova
BIOCAD Biotechnology Co.
Author for correspondence.
Email: lomkova@anchem.pro
Russian Federation, Strelna, St. Petersburg, 198515
V. O. Shitikova
BIOCAD Biotechnology Co.
Email: lomkova@anchem.pro
Russian Federation, Strelna, St. Petersburg, 198515
A. A. Tsukur
BIOCAD Biotechnology Co.; St. Petersburg State Chemical Pharmaceutical Academy
Email: lomkova@anchem.pro
Russian Federation, Strelna, St. Petersburg, 198515; St. Petersburg, 197376
A. A. Sozonova
BIOCAD Biotechnology Co.
Email: lomkova@anchem.pro
Russian Federation, Strelna, St. Petersburg, 198515
A. M. Ryakhovskaya
BIOCAD Biotechnology Co.
Email: lomkova@anchem.pro
Russian Federation, Strelna, St. Petersburg, 198515
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