BACKGROUND: Recent reports have demonstrated that refrigerated bevacizumab can be stored for up to 3 weeks at 4 degrees C without loss of efficacy. There have been no previous reports addressing bevacizumab's sterility when stored and used as multiple doses from a single-use vial. OBJECTIVE: To evaluate the sterility of bevacizumab when used as multiple doses from a single-use vial. METHODS: Four groups of vials were used to simulate the storage and use conditions for bevacizumab. Each group contained 11 doses of 0.2 mL of bevacizumab. One sample from each group was cultured once each day at 37 degrees C for 10 days; one sample from each group was left for 15 days. MacConkey agar, blood agar, thioglycollate broth, and Sabouraud medium were used to assess bacterial and fungal growth. RESULTS: A total of 44 samples of bevacizumab were included in this study. Each sample was placed on 4 growth media for microbial readings. All samples were found to be negative for microbial growth. No significant differences were observed among the groups. Possible limitations of this study included the number of samples for each group and in vitro design of the study, which might have affected the growth of bacterial organisms. CONCLUSIONS: Storage and multiple use of bevacizumab from single-use vials does not seem to result in microbial contamination.
BACKGROUND: Recent reports have demonstrated that refrigerated bevacizumab can be stored for up to 3 weeks at 4 degrees C without loss of efficacy. There have been no previous reports addressing bevacizumab's sterility when stored and used as multiple doses from a single-use vial. OBJECTIVE: To evaluate the sterility of bevacizumab when used as multiple doses from a single-use vial. METHODS: Four groups of vials were used to simulate the storage and use conditions for bevacizumab. Each group contained 11 doses of 0.2 mL of bevacizumab. One sample from each group was cultured once each day at 37 degrees C for 10 days; one sample from each group was left for 15 days. MacConkey agar, blood agar, thioglycollate broth, and Sabouraud medium were used to assess bacterial and fungal growth. RESULTS: A total of 44 samples of bevacizumab were included in this study. Each sample was placed on 4 growth media for microbial readings. All samples were found to be negative for microbial growth. No significant differences were observed among the groups. Possible limitations of this study included the number of samples for each group and in vitro design of the study, which might have affected the growth of bacterial organisms. CONCLUSIONS: Storage and multiple use of bevacizumab from single-use vials does not seem to result in microbial contamination.
Authors: Peter K Kaiser; Alan F Cruess; Peter Bogaert; Kamlesh Khunti; Simon P Kelly Journal: Graefes Arch Clin Exp Ophthalmol Date: 2012-08-12 Impact factor: 3.117