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Development of Improved High-Performance Liquid Chromatography Method for the Determination of Residual Caprylic Acid in Formulations of Human Immunoglobulins.
Stimac, Adela; Kurtovic, Tihana; Pavlovic, Nediljko; Halassy, Beata.
  • Stimac A; Centre for Research and Knowledge Transfer in Biotechnology, University of Zagreb, Rockefellerova 10, 10000 Zagreb, Croatia.
  • Kurtovic T; Centre for Research and Knowledge Transfer in Biotechnology, University of Zagreb, Rockefellerova 10, 10000 Zagreb, Croatia.
  • Pavlovic N; Institute of Immunology, Inc., Rockefellerova 10, 10000 Zagreb, Croatia.
  • Halassy B; Centre for Research and Knowledge Transfer in Biotechnology, University of Zagreb, Rockefellerova 10, 10000 Zagreb, Croatia.
Molecules ; 27(5)2022 Mar 03.
Article in English | MEDLINE | ID: covidwho-1732129
ABSTRACT
Quality control of human immunoglobulin formulations produced by caprylic acid precipitation necessitates a simple, rapid, and accurate method for determination of residual caprylic acid. A high-performance liquid chromatography method for that purpose was developed and validated. The method involves depletion of immunoglobulins, the major interfering components that produce high background noise, by precipitation with acetonitrile (11, v/v). Chromatographic analysis of caprylic acid, preserved in supernatant with no loss, was performed using a reverse-phase C18 column (2.1 × 150 mm, 3 µm) as a stationary phase and water with 0.05% TFA-acetonitrile (5050, v/v) as a mobile phase at a flow rate of 0.2 mL/min and run time of 10 min. The developed method was successfully validated according to the ICH guidelines. The validation parameters confirmed that method was linear, accurate, precise, specific, and able to provide excellent separation of peaks corresponding to caprylic acid and the fraction of remaining immunoglobulins. Furthermore, a 24-1 fractional factorial design was applied in order to test the robustness of developed method. As such, the method is highly suitable for the quantification of residual caprylic acid in formulations of human immunoglobulins for therapeutic use, as demonstrated on samples produced by fractionation of convalescent anti-SARS-CoV-2 human plasma at a laboratory scale. The obtained results confirmed that the method is convenient for routine quality control.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulins / Caprylates / Chromatography, High Pressure Liquid / Drug Compounding Type of study: Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal subject: Biology Year: 2022 Document Type: Article Affiliation country: Molecules27051665

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulins / Caprylates / Chromatography, High Pressure Liquid / Drug Compounding Type of study: Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal subject: Biology Year: 2022 Document Type: Article Affiliation country: Molecules27051665