{
  "abstract": "Objective After patent expiry of the bevacizumab originator product, several biosimilars were approved by the European Medicines Agency. In centralised preparation units, product-specific in-use stability data must be considered. Based on the available data, stability information was missing for the concentrate for solution of the bevacizumab biosimilar CT-P16 (Vegzelma, Celltrion) after first opening and prolonged storage. The aim of the study was to investigate the physicochemical stability of CT-P16 25 mg/mL concentrate for solution stored in punctured original glass vials at two different storage temperatures over a 28-day period.Methods Three bevacizumab 25 mg/mL vials (CT-P16) were stored punctured either light protected at 2–8°C or at 25±2°C for 28 days. Samples were withdrawn on day 0, 1, 7, 14, 21, 28 and analysed by size-exclusion chromatography (SE-HPLC), ion-exchange chromatography (IE-HPLC), and dynamic light scattering (DLS). In parallel, pH values were measured and test vials visually inspected for visible particles and colour changes.Results After the 28-day storage period, the quantitative SE-HPLC analysis indicated bevacizumab concentrations above 95% of the initial concentration in each test vial. IE-HPLC analysis revealed no signs of instability. DLS measurements showed no significant variation in the mean hydrodynamic diameter and no appearance of small-sized aggregates. The pH values of all samples remained constant, and no visible particles or colour changes were observed.Conclusion CT-P16 25 mg/mL concentrate was found to be physicochemically stable in the original glass vial after first opening for at least 28 days when stored light protected at 2–8°C or at 25±2°C.",
  "authors": [
    {
      "affiliations": [
        "Pharmacy, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Rheinland-Pfalz, Germany"
      ],
      "name": "Laura Kirsch"
    },
    {
      "affiliations": [
        "Pharmacy, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Rheinland-Pfalz, Germany"
      ],
      "name": "Helen Linxweiler"
    },
    {
      "affiliations": [
        "Pharmacy, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Rheinland-Pfalz, Germany"
      ],
      "name": "Judith Thiesen"
    },
    {
      "affiliations": [
        "Pharmacy, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Rheinland-Pfalz, Germany"
      ],
      "name": "Irene Kraemer"
    }
  ],
  "title": "Physicochemical stability of bevacizumab biosimilar CT-P16 (Vegzelma) concentrate for solution stored in original vials after first opening",
  "uid": "0e58a4b1-2caf-58e1-9abc-c4c14f9d7bbe"
}