Injectable hydrogel particles for amorphous solid formulation of biologics
Summary: 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 tha...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-08-01
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| Series: | iScience |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589004223015298 |
| _version_ | 1797753885963583488 |
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| author | Amir Erfani Paul Reichert Chakravarthy N. Narasimhan Patrick S. Doyle |
| author_facet | Amir Erfani Paul Reichert Chakravarthy N. Narasimhan Patrick S. Doyle |
| author_sort | Amir Erfani |
| collection | DOAJ |
| description | Summary: 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 | 2024-03-12T17:25:23Z |
| format | Article |
| id | doaj.art-517305317ae34b71952ac7edde0d210c |
| institution | Directory Open Access Journal |
| issn | 2589-0042 |
| language | English |
| last_indexed | 2024-03-12T17:25:23Z |
| publishDate | 2023-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | iScience |
| spelling | doaj.art-517305317ae34b71952ac7edde0d210c2023-08-05T05:17:44ZengElsevieriScience2589-00422023-08-01268107452Injectable hydrogel particles for amorphous solid formulation of biologicsAmir Erfani0Paul Reichert1Chakravarthy N. Narasimhan2Patrick S. Doyle3Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA 02142, USAMerck & Co., Inc., Kenilworth, NJ 07033, USAMerck & Co., Inc., Kenilworth, NJ 07033, USADepartment of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA 02142, USA; Harvard Medical School Initiative for RNA Medicine, Boston, MA 02215, USA; Corresponding authorSummary: 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.http://www.sciencedirect.com/science/article/pii/S2589004223015298BioengineeringMaterials scienceBiomaterialsPolymers |
| spellingShingle | Amir Erfani Paul Reichert Chakravarthy N. Narasimhan Patrick S. Doyle Injectable hydrogel particles for amorphous solid formulation of biologics iScience Bioengineering Materials science Biomaterials Polymers |
| 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 |
| topic | Bioengineering Materials science Biomaterials Polymers |
| url | http://www.sciencedirect.com/science/article/pii/S2589004223015298 |
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