Development of a Pharmaceutical Composition and Stablity of Liquid Dosage Forms Based on Monoclonal IgG1 Antibodies


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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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