Physicochemical and Biological Stability Assessment of SB11 (Ranibizumab Biosimilar) Under Ambient and In-Use Storage for Intravitreal Administration.
Peter K KaiserJihoon YunSoyeon KimJihyun KimSu Jin ParkPublished in: Ophthalmology and therapy (2023)
SB11 was stable for longer periods and at higher temperatures than what is stated in the labels of the reference product (Lucentis) and SB11. The physicochemical properties, biological activity, and sub-visible particulates of SB11 in both tested settings (unopened vials at room temperature and in-use product withdrawn into syringes) were maintained under the described storage periods. This information can help to avoid unnecessary delays in patient treatment without any loss in quality and biological activity, lower the workload of health care providers and reduce costs associated with drug waste.
Keyphrases
- room temperature
- healthcare
- diabetic retinopathy
- air pollution
- age related macular degeneration
- ionic liquid
- case report
- vascular endothelial growth factor
- heavy metals
- risk assessment
- emergency department
- quality improvement
- combination therapy
- health insurance
- municipal solid waste
- replacement therapy
- clinical evaluation