Kim Shepard*, Molly Adam, John Baumann, Julia Oddo, Amanda Pluntze, Lauren Switala & David Vodak
Co-authors: Philip Kuehl, David Revelli and Yue Zhou (Lovelace Biomedical, Albuquerque, NM)
Shepard et al, “Local Treatment of Non-small cell lung cancer with a spray-dried bevacizumab formulation” AAPS PharmSciTech (2021)
BACKGROUND
Bevacizumab
Bevacizumab is a monoclonal antibody VEGF-inhibitor which is an approved product for treatment of cancers, as well as age-related macular degeneration. It works by inhibiting the growth of blood vessels, which are essential for growth of tumors in cancer.
Use for NSCLC
PURPOSE
Project goals
Demonstrate a platform for inhaled biologics manufactured by spray drying, which can be shared in a peer-reviewed article
Product goals
Develop a formulation of bevacizumab for local delivery to the lung using a dry powder inhaler. Potential to:
Formulation goals
Manufacture an SDD using bevacizumab, trehalose and L-leucine which achieves:
MANUFACTURING
SDD formulation:
40/40/20 bevacizumab/ trehalose/ L-leucine by weight
Spray drying parameters
Develop a formulation of bevacizumab for local delivery to the lung using a dry powder inhaler. Potential to:
RESULTS
Particle size and respirability
VEGF inhibition
Physical state and stability
Efficacy study in rats
CONCLUSIONS
Inhalation particle size
Next-Generation Impactor shows a high fine particle fraction, meaning much of the powder will be delivered to the deep lung.
Retains anti-VEGF activity
Bevacizumab retains similar biological anti-VEGF activity to control solution after spray drying, as measured by a Promega luminescence assay kit.
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