Injectable hydrogel particles for amorphous solid formulation of biologics
Name
1-s2.0-S2589004223015298-main.pdf
Description
Published version
Size
5.33 MB
Format
Adobe PDF
Checksum (MD5)
1847ac1510fe9f512f561ad6102af018
Author(s)
Erfani, Amir
Reichert, Paul
Narasimhan, Chakravarthy N
Doyle, Patrick S
Date Issued
August 2023
Journal
iScience
Publisher
Elsevier BV
Citation
Erfani, Amir, Reichert, Paul, Narasimhan, Chakravarthy N and Doyle, Patrick S. 2023. "Injectable hydrogel particles for amorphous solid formulation of biologics." iScience, 26 (8).
Version
Final published version
Abstract
The fast pace of breakthroughs in cancer immunotherapy, combined with the new paradigm of moving toward high-concentration dosages and combinatorial treatments, is generating new challenges in the formulation of biologics. To address these challenges, we describe a method of formulation that enables high-concentration injectable and stable formulation of biologics as amorphous solids in aqueous suspension. This technology combines the benefits of liquid formulation with the stability of solid formulation and eliminates the need for drying and reconstitution. This widely applicable formulation integrates the amorphous solid forms of antibodies with the injectability, lubricity, and tunability of soft alginate hydrogel particles using a minimal process. The platform was evaluated for anti-PD-1 antibody pembrolizumab and human immunoglobulin G at concentrations up to 300 mg/mL with confirmed quality after release. The soft nature of the hydrogel matrix allowed packing the particles to high volume fractions.
MIT Department
Massachusetts Institute of Technology. Department of Chemical Engineering
Terms of Use
Creative Commons Attribution-NonCommercial-NoDerivatives
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DOI of Published Version
https://doi.org/10.1016/j.isci.2023.107452
