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Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations
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Zeitschriftentitel: | Advanced Therapeutics |
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Personen und Körperschaften: | , , , , |
In: | Advanced Therapeutics, 4, 2021, 4 |
Format: | E-Article |
Sprache: | Englisch |
veröffentlicht: |
Wiley
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Schlagwörter: |
author_facet |
Schieferstein, Jeremy M. Reichert, Paul Narasimhan, Chakravarthy N. Yang, Xiaoyu Doyle, Patrick S. Schieferstein, Jeremy M. Reichert, Paul Narasimhan, Chakravarthy N. Yang, Xiaoyu Doyle, Patrick S. |
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author |
Schieferstein, Jeremy M. Reichert, Paul Narasimhan, Chakravarthy N. Yang, Xiaoyu Doyle, Patrick S. |
spellingShingle |
Schieferstein, Jeremy M. Reichert, Paul Narasimhan, Chakravarthy N. Yang, Xiaoyu Doyle, Patrick S. Advanced Therapeutics Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations Pharmacology (medical) Biochemistry (medical) Genetics (clinical) Pharmaceutical Science Pharmacology Medicine (miscellaneous) |
author_sort |
schieferstein, jeremy m. |
spelling |
Schieferstein, Jeremy M. Reichert, Paul Narasimhan, Chakravarthy N. Yang, Xiaoyu Doyle, Patrick S. 2366-3987 2366-3987 Wiley Pharmacology (medical) Biochemistry (medical) Genetics (clinical) Pharmaceutical Science Pharmacology Medicine (miscellaneous) http://dx.doi.org/10.1002/adtp.202000216 <jats:title>Abstract</jats:title><jats:p>Monoclonal antibodies are therapeutic molecules known for their high specificity and versatility in the treatment of cancer and autoimmune disorders, but dosage forms are typically limited to low concentrations and large fluid volumes due to formulation challenges. Hydrogel microsphere formulations offer a route to quicker, patient‐friendly dosing regimens for monoclonal antibodies with high loading and favorable flow properties needed for injection through a narrow syringe needle under moderate applied force. Crystals of an intact monoclonal antibody are prepared as a concentrated suspension (>300 mg mL<jats:sup>−1</jats:sup>) which is then encapsulated within hydrogel microspheres with diameters as small as 30 µm. The hydrogel microspheres contain up to 56 wt% (dry basis) monoclonal antibody and release within 4 days under in vitro dissolution conditions. The hydrogel microspheres are concentrated into densely packed suspensions containing up to 300 mg mL<jats:sup>−1</jats:sup> monoclonal antibody to evaluate their flow. These hydrogel formulations shear‐thin and have lower viscosity when compared to both liquid and suspended crystal forms of the monoclonal antibody, demonstrating the potential of hydrogel microsphere encapsulants as a carrier which can mask undesirable flow properties of concentrated antibody therapeutics.</jats:p> Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations Advanced Therapeutics |
doi_str_mv |
10.1002/adtp.202000216 |
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Chemie und Pharmazie Medizin |
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Advanced Therapeutics |
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title |
Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_unstemmed |
Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_full |
Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_fullStr |
Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_full_unstemmed |
Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_short |
Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_sort |
hydrogel microsphere encapsulation enhances the flow properties of monoclonal antibody crystal formulations |
topic |
Pharmacology (medical) Biochemistry (medical) Genetics (clinical) Pharmaceutical Science Pharmacology Medicine (miscellaneous) |
url |
http://dx.doi.org/10.1002/adtp.202000216 |
publishDate |
2021 |
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<jats:title>Abstract</jats:title><jats:p>Monoclonal antibodies are therapeutic molecules known for their high specificity and versatility in the treatment of cancer and autoimmune disorders, but dosage forms are typically limited to low concentrations and large fluid volumes due to formulation challenges. Hydrogel microsphere formulations offer a route to quicker, patient‐friendly dosing regimens for monoclonal antibodies with high loading and favorable flow properties needed for injection through a narrow syringe needle under moderate applied force. Crystals of an intact monoclonal antibody are prepared as a concentrated suspension (>300 mg mL<jats:sup>−1</jats:sup>) which is then encapsulated within hydrogel microspheres with diameters as small as 30 µm. The hydrogel microspheres contain up to 56 wt% (dry basis) monoclonal antibody and release within 4 days under in vitro dissolution conditions. The hydrogel microspheres are concentrated into densely packed suspensions containing up to 300 mg mL<jats:sup>−1</jats:sup> monoclonal antibody to evaluate their flow. These hydrogel formulations shear‐thin and have lower viscosity when compared to both liquid and suspended crystal forms of the monoclonal antibody, demonstrating the potential of hydrogel microsphere encapsulants as a carrier which can mask undesirable flow properties of concentrated antibody therapeutics.</jats:p> |
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author | Schieferstein, Jeremy M., Reichert, Paul, Narasimhan, Chakravarthy N., Yang, Xiaoyu, Doyle, Patrick S. |
author_facet | Schieferstein, Jeremy M., Reichert, Paul, Narasimhan, Chakravarthy N., Yang, Xiaoyu, Doyle, Patrick S., Schieferstein, Jeremy M., Reichert, Paul, Narasimhan, Chakravarthy N., Yang, Xiaoyu, Doyle, Patrick S. |
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description | <jats:title>Abstract</jats:title><jats:p>Monoclonal antibodies are therapeutic molecules known for their high specificity and versatility in the treatment of cancer and autoimmune disorders, but dosage forms are typically limited to low concentrations and large fluid volumes due to formulation challenges. Hydrogel microsphere formulations offer a route to quicker, patient‐friendly dosing regimens for monoclonal antibodies with high loading and favorable flow properties needed for injection through a narrow syringe needle under moderate applied force. Crystals of an intact monoclonal antibody are prepared as a concentrated suspension (>300 mg mL<jats:sup>−1</jats:sup>) which is then encapsulated within hydrogel microspheres with diameters as small as 30 µm. The hydrogel microspheres contain up to 56 wt% (dry basis) monoclonal antibody and release within 4 days under in vitro dissolution conditions. The hydrogel microspheres are concentrated into densely packed suspensions containing up to 300 mg mL<jats:sup>−1</jats:sup> monoclonal antibody to evaluate their flow. These hydrogel formulations shear‐thin and have lower viscosity when compared to both liquid and suspended crystal forms of the monoclonal antibody, demonstrating the potential of hydrogel microsphere encapsulants as a carrier which can mask undesirable flow properties of concentrated antibody therapeutics.</jats:p> |
doi_str_mv | 10.1002/adtp.202000216 |
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spelling | Schieferstein, Jeremy M. Reichert, Paul Narasimhan, Chakravarthy N. Yang, Xiaoyu Doyle, Patrick S. 2366-3987 2366-3987 Wiley Pharmacology (medical) Biochemistry (medical) Genetics (clinical) Pharmaceutical Science Pharmacology Medicine (miscellaneous) http://dx.doi.org/10.1002/adtp.202000216 <jats:title>Abstract</jats:title><jats:p>Monoclonal antibodies are therapeutic molecules known for their high specificity and versatility in the treatment of cancer and autoimmune disorders, but dosage forms are typically limited to low concentrations and large fluid volumes due to formulation challenges. Hydrogel microsphere formulations offer a route to quicker, patient‐friendly dosing regimens for monoclonal antibodies with high loading and favorable flow properties needed for injection through a narrow syringe needle under moderate applied force. Crystals of an intact monoclonal antibody are prepared as a concentrated suspension (>300 mg mL<jats:sup>−1</jats:sup>) which is then encapsulated within hydrogel microspheres with diameters as small as 30 µm. The hydrogel microspheres contain up to 56 wt% (dry basis) monoclonal antibody and release within 4 days under in vitro dissolution conditions. The hydrogel microspheres are concentrated into densely packed suspensions containing up to 300 mg mL<jats:sup>−1</jats:sup> monoclonal antibody to evaluate their flow. These hydrogel formulations shear‐thin and have lower viscosity when compared to both liquid and suspended crystal forms of the monoclonal antibody, demonstrating the potential of hydrogel microsphere encapsulants as a carrier which can mask undesirable flow properties of concentrated antibody therapeutics.</jats:p> Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations Advanced Therapeutics |
spellingShingle | Schieferstein, Jeremy M., Reichert, Paul, Narasimhan, Chakravarthy N., Yang, Xiaoyu, Doyle, Patrick S., Advanced Therapeutics, Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations, Pharmacology (medical), Biochemistry (medical), Genetics (clinical), Pharmaceutical Science, Pharmacology, Medicine (miscellaneous) |
title | Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_full | Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_fullStr | Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_full_unstemmed | Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_short | Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
title_sort | hydrogel microsphere encapsulation enhances the flow properties of monoclonal antibody crystal formulations |
title_unstemmed | Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations |
topic | Pharmacology (medical), Biochemistry (medical), Genetics (clinical), Pharmaceutical Science, Pharmacology, Medicine (miscellaneous) |
url | http://dx.doi.org/10.1002/adtp.202000216 |