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LONG-TERM PHYSICAL STABILITY, STERILITY, AND ANTI-VEGF BIOACTIVITY OF REPACKAGED BEVACIZUMAB IN 2-ML GLASS VIALS

Peterson, Jan, S., MS, RAC*; Rockwell, Kenneth, Jr, PharmD, MS; Scott, Ingrid, U., MD, MPH; Ip, Michael, S., MD§; VanVeldhuisen, Paul, C., PhD*; Blodi, Barbara, A., MDfor the SCORE2 Investigator Group

doi: 10.1097/IAE.0000000000002212
Original Study: PDF Only

Purpose: Repackaged bevacizumab in single-dose, prefilled syringes for intravitreal injection is available, but with shelf life limited from 60 days to 90 days. For the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2), 2-mL sterile glass vials were used rather than prefilled syringes to provide a longer shelf life for study supplies.

Methods: Repackaged bevacizumab in glass vials was tested at release and, for 1 lot, after 1, 3, 6, and 12 months for physical stability, including concentration, purity and appearance, and for sterility and endotoxins. Vials from 2 lots were tested at release and after 20 months and 21 months, respectively. One lot was tested at 21 months for anti-VEGF bioactivity compared with a fresh supply of commercial bevacizumab.

Results: Repackaged bevacizumab in 2-mL glass vials continued to meet all quality release specifications and remain sterile for up to 21 months. In addition, no degradation in anti-VEGF bioactivity was observed at 21 months compared with a fresh bevacizumab control.

Conclusion: Bevacizumab can be repackaged into small, single-dose glass vials for intravitreal injection and the qualities of the commercial product maintained, including anti-VEGF bioactivity, for up to 21 months in refrigerated storage. Consideration should be given to repackaging bevacizumab for ophthalmic use in small glass vials as opposed to plastic syringes.

Repackaged clinical trial supplies of bevacizumab in small, single-use glass vials for SCORE2 maintained physical stability and sterility with no degradation of anti-VEGF bioactivity for up to 21 months.

*The Emmes Corporation, Rockville, Maryland;

Investigational Drug Service, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;

Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania;

§Doheny Eye Institute, University of California-Los Angeles, Los Angeles, California; and

Fundus Photograph Reading Center, University of Wisconsin, Madison, Wisconsin.

Reprint requests: Paul C. VanVeldhuisen, PhD, The Emmes Corporation, 401 N Washington Street, Suite 700, Rockville, MD 20850; e-mail: pvanveldhuisen@emmes.com

Research reported in this publication was supported by the National Eye Institute of the National Institutes of Health under Award Number U10EY023529.

None of the authors has any financial/conflicting interests to disclose.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Clinical trial identifier: NCT01969708.

© 2018 by Ophthalmic Communications Society, Inc.