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.
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 (&gt;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
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series Advanced Therapeutics
source_id 49
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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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 (&gt;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.
author_sort schieferstein, jeremy m.
container_issue 4
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container_title Advanced Therapeutics
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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 (&gt;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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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 (&gt;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