title: Safety, sterility and stability of direct-from-vial multiple dosing intravitreal injection of bevacizumab.
abstract: BACKGROUND
  This study aims to determine the stability, sterility and safety of bevacizumab multiple dosing from a single vial without prior aliquoting.
  
  
  METHODS
  In-vitro and human study. Six bevacizumab vials, used in multiple patients on a single day by direct withdrawal from the vial, and stored in 4°C up to a variable period, were tested for stability (high-performance liquid chromatography; [HPLC]), sterility (culture), conformational stability by circular dichroism and fluorescence spectroscopy and the rubber cork structural integrity (electron microscopy [EM]).
  
  
  RESULTS
  HPLC of all six samples of used bevacizumab and the control bevacizumab sample were similar; culture was negative; and the EM of rubber corks did not show an open communication. Spectroscopic studies indicated drug conformational stability. Further, there was no infection or inflammation in 221 consecutive patients (973 injections) when bevacizumab was stored at 4°C and used for one week.
  
  
  CONCLUSIONS
  Bevacizumab does not lose stability when stored at 4°C. It may be used for a week by direct withdrawal from the vial without fear of infection or inflammation if all standard precautions related to intravitreal injection are adhered to.
authors.affiliation: Retina Vitreous, L V Prasad Eye Institute, Bhubaneswar, India.|Microbiology, L V Prasad Eye Institute, Bhubaneswar, India.
authors.forename: Taraprasad
authors.initials: T
authors.lastname: Das
authors.affiliation: Centre for Cellular and Molecular Biology, Hyderabad, India.
authors.forename: Srinivas
authors.initials: S
authors.lastname: Volety
authors.affiliation: Centre for Cellular and Molecular Biology, Hyderabad, India.
authors.forename: Saad M
authors.initials: SM
authors.lastname: Ahsan
authors.affiliation: Centre for Cellular and Molecular Biology, Hyderabad, India.
authors.forename: Abhay K
authors.initials: AK
authors.lastname: Thakur
authors.affiliation: Retina Vitreous, L V Prasad Eye Institute, Bhubaneswar, India.|Microbiology, L V Prasad Eye Institute, Bhubaneswar, India.
authors.forename: Savitri
authors.initials: S
authors.lastname: Sharma
authors.affiliation: Retina Vitreous, L V Prasad Eye Institute, Bhubaneswar, India.
authors.forename: Tapas R
authors.initials: TR
authors.lastname: Padhi
authors.affiliation: Retina Vitreous, L V Prasad Eye Institute, Bhubaneswar, India.
authors.forename: Soumyava
authors.initials: S
authors.lastname: Basu
authors.affiliation: Centre for Cellular and Molecular Biology, Hyderabad, India.
authors.forename: Ch Mohan
authors.initials: ChM
authors.lastname: Rao
mesh_terms: D020533:Angiogenesis Inhibitors / Q000737:chemistry*; D001419:Bacteria / Q000254:growth & development; D000068258:Bevacizumab / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D002942:Circular Dichroism; D004340:Drug Contamination; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D058449:Intravitreal Injections; D013050:Spectrometry, Fluorescence; D013242:Sterilization; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors
chemical_list: D020533:Angiogenesis Inhibitors; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab
keywords: age-related macular degeneration; diabetic retinopathy; ocular drug therapy