title: Quality of bevacizumab compounded for intravitreal administration.
abstract: OBJECTIVE
  To compare the quality and stability of unlicensed, repackaged bevacizumab intended for intravitreal injection, as provided by five licensed compounding pharmacies in the United Kingdom, with bevacizumab in its original glass vial.
  
  
  METHODS
  Repackaged bevacizumab was obtained from five UK suppliers. Samples were analyzed at two time points (day 1 and day 14). Microflow imaging was performed to evaluate subvisible particle size, particle density, and particle size distribution. Protein concentration, immunoglobulin G (IgG) content, and molecular weight were also determined.
  
  
  RESULTS
  A significant difference in subvisible particle density was observed between bevacizumab batches from the five suppliers on day 1 (P<0.001). An increase in subvisible particle density was observed between day 1 and 14 for repackaged bevacizumab from all suppliers (all P<0.05), but not the reference compound. Protein concentration, IgG content, and molecular weight were comparable between batches from each supplier and the reference bevacizumab.
  
  
  CONCLUSIONS
  The study results indicate that the quality of bevacizumab repackaged into prefilled plastic syringes is variable among the different compounding pharmacies in the United Kingdom. Furthermore, particle density may increase with storage in repackaged syringes. It is noteworthy that particle size distribution in both the repackaged and reference bevacizumab fell outside of the range specified by the United States Pharmacopeia for injectable ophthalmic solutions. These data highlight the need for further research into the use of unlicensed, repackaged bevacizumab intended for intravitreal injection.
authors.affiliation: Institute of Cellular Medicine, Newcastle University, Newcastle Upon Tyne, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Palmer
authors.forename: W M
authors.initials: WM
authors.lastname: Amoaku
authors.forename: F
authors.initials: F
authors.lastname: Kamali
mesh_terms: D020533:Angiogenesis Inhibitors / Q000737:chemistry*; D061067:Antibodies, Monoclonal, Humanized / Q000737:chemistry*; D000068258:Bevacizumab; D004339:Drug Compounding / Q000592:standards; D004349:Drug Packaging / Q000592:standards*; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods; D007074:Immunoglobulin G / Q000032:analysis; D058449:Intravitreal Injections; D010316:Particle Size; D011506:Proteins / Q000032:analysis; D013594:Syringes; D006113:United Kingdom
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D011506:Proteins; D000068258:Bevacizumab