Injectable hydrogel particles for amorphous solid formulation of biologics
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...
| Main Authors: | , , , |
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| Other Authors: | |
| Format: | Article |
| Language: | English |
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Elsevier BV
2025
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| Online Access: | https://hdl.handle.net/1721.1/158265 |
| _version_ | 1826198641649385472 |
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| author | Erfani, Amir Reichert, Paul Narasimhan, Chakravarthy N Doyle, Patrick S |
| author2 | Massachusetts Institute of Technology. Department of Chemical Engineering |
| author_facet | Massachusetts Institute of Technology. Department of Chemical Engineering Erfani, Amir Reichert, Paul Narasimhan, Chakravarthy N Doyle, Patrick S |
| author_sort | Erfani, Amir |
| collection | MIT |
| description | 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. |
| first_indexed | 2025-03-10T09:25:41Z |
| format | Article |
| id | mit-1721.1/158265 |
| institution | Massachusetts Institute of Technology |
| language | English |
| last_indexed | 2025-03-10T09:25:41Z |
| publishDate | 2025 |
| publisher | Elsevier BV |
| record_format | dspace |
| spelling | mit-1721.1/1582652025-02-25T18:09:33Z Injectable hydrogel particles for amorphous solid formulation of biologics Erfani, Amir Reichert, Paul Narasimhan, Chakravarthy N Doyle, Patrick S Massachusetts Institute of Technology. Department of Chemical Engineering 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. 2025-02-25T18:09:32Z 2025-02-25T18:09:32Z 2023-08 2025-02-25T17:54:26Z Article http://purl.org/eprint/type/JournalArticle https://hdl.handle.net/1721.1/158265 Erfani, Amir, Reichert, Paul, Narasimhan, Chakravarthy N and Doyle, Patrick S. 2023. "Injectable hydrogel particles for amorphous solid formulation of biologics." iScience, 26 (8). en 10.1016/j.isci.2023.107452 iScience Creative Commons Attribution-NonCommercial-NoDerivatives https://creativecommons.org/licenses/by-nc-nd/4.0/ application/pdf Elsevier BV Elsevier BV |
| spellingShingle | Erfani, Amir Reichert, Paul Narasimhan, Chakravarthy N Doyle, Patrick S Injectable hydrogel particles for amorphous solid formulation of biologics |
| title | Injectable hydrogel particles for amorphous solid formulation of biologics |
| title_full | Injectable hydrogel particles for amorphous solid formulation of biologics |
| title_fullStr | Injectable hydrogel particles for amorphous solid formulation of biologics |
| title_full_unstemmed | Injectable hydrogel particles for amorphous solid formulation of biologics |
| title_short | Injectable hydrogel particles for amorphous solid formulation of biologics |
| title_sort | injectable hydrogel particles for amorphous solid formulation of biologics |
| url | https://hdl.handle.net/1721.1/158265 |
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