460 Journal of Pharmacy and Pharmacology, 2021, Vol 73, 460–472 doi:10.1093/jpp/rgaa068 Research Paper Advance Access publication 1 February 2021 © The Author(s) 2021. Published by Oxford University Press on behalf of the Royal Pharmaceutical Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com Research Paper Anti-Aβ-scFv-loaded polymeric nano-micelles with enhanced plasma stability Farnaz Sotoudegan 1 , Farzaneh Sotoudegan 2 , Yeganeh Talebkhan Garoosi 1 , Sahar H. Afshar 3 , Farzaneh Barkhordari 1 and Fatemeh Davami 1, * , 1 Biotechnology Research Center, Pasteur Institute of Iran, Tehran, Iran, 2 Pharmaceutical Quality Assurance Research Center, The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran, Iran 3 Faculty of Pharmacy International Campus, Tehran University of Medical Sciences, Tehran, Iran *Correspondence: Fatemeh Davami, Biotechnology Research Center, Pasteur Institute of Iran, 12th Farvardin Avenue, Enghelab Square, Tehran, Iran. Email: f_davami@pasteur.ac.ir Received April 20, 2020; Accepted December 23, 2020. Abstract Objectives Immunotherapy using recombinant monoclonal antibodies specifically Anti-amyloid- beta (Anti-Aβ) scFv is envisaged as an appropriate therapeutic for Alzheimer through reduction of amyloid-beta aggregation. The solubilization of therapeutics using polymeric micelles facilitates an improved bioavailability and extended blood half-life. In this study, the optimum production condition for Anti-amyloid-beta (Anti-Aβ) scFv was obtained. To increase the stability of plasma, Anti-Aβ-loaded polymeric micelles were synthesized. Methods Escherichia coli SHuffle expression strain was used and purified by Ni-NTA. Pluronics P85 and F127 micelles were used for the Anti-Aβ delivery and were characterized in terms of morph- ology, drug loading and drug release in phosphate buffer and artificial cerebrospinal fluid. The stability profile was quantified at 4°C over a 30 days storage period. The stability in human plasma was also evaluated. Key findings Proteins expressed in SHuffle resulted in increased levels of protein expression and solubility. Low critical micelle concentration value and high micelle encapsulation efficiency (<200 nm) achieved via direct dissolution method. Anti-Aβ-loaded micelles were around 2.2-fold more stable than Anti-Aβ in plasma solution. A sustained in-vitro release of Anti-Aβ from micelles was observed. Conclusions Results confirmed that Pluronic-micelles pose benefits as a nano-carrier to increase the stability of Anti-Aβ scFvin in the plasma. Downloaded from https://academic.oup.com/jpp/article/73/4/460/6125379 by guest on 02 July 2022