Enabling subcutaneous delivery of therapeutic monoclonal antibodies via hydrogel microparticles

Ended Project Grant Awarded Last action

Award ID
R43TR004761
Recipient
Awarding agency
Obligated
$754,976

Award facts

Completion date
Place of performance
Massachusetts, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Monoclonal antibodies (MABS) provide unchallenged specificity compared to small molecules, representing a growing market of 150+ billion dollars. Due to their structural complexity and poor stability, however, they remain difficult to formulate at high concentrations, making intravenous (IV) delivery of MABS the "gold standard". IV injections present major drawbacks, such as patient discomfort, long INJECTION times, and high medical costs associated with in-hospital administration. Subcutaneous (SC) delivery is a convenient route of administration for large molecules, as IT allows for rapid injections (SECONDS), requires minimal skills (SELF-INJECTION), and allows for systemic delivery. IT remains an open challenge to reformulate MABS to a SC form. Most MABS requires large dosage to be effective (>300 MG), and SC administration volumes are constrained to only 1-2 ML, hundreds of times smaller than typical IV formulations SC injections using hydrogel microparticles (HMP) offer a promising method for encapsulating and delivering protein-based drugs. The composition, size, and mechanical properties of hmps can be widely tuned to facilitate their INJECTION through needles for subcutaneous delivery. Alginate-based MP are becoming increasingly popular due to their rheological properties and high biocompatibility. Additionally, the anionic nature of alginate enables electrostatic entrapment of cationic proteins independently of the hydrogel porosity, making IT a candidate for hydrogel-based antibody formulations. However, current manufacturing technologies are limited to low concentration of polymer (100MG/ML), including alginate (>10%); low particle size variation (coefficient of variation of 1-3%) reducing costly sieving steps, consistency in cargo encapsulation and delivery - hence significantly improving good manufacturing practices - even at extreme loading. This project aims to: (1) manufacture MABS loaded hydrogel-based microparticles for SC delivery and characterize them in-vitro, including encapsulation efficiency, release profile, and injectability. (2) conduct in vivo study to investigate safety, bioavailability, and bioactivity of the MP-based formulations in murine models.

Transactions

Action Obligated Date
Amendment $0
Amendment $52,988
Amendment $52,988
Amendment $324,500
Original award $324,500

Quick answers

Who received award R43TR004761?

R43TR004761 was awarded to Acousticabio, Inc. by National Center for Advancing Translational Sciences (National Institutes of Health) on August 1, 2023.

How much is award R43TR004761 worth?

$754,976 has been obligated on R43TR004761.

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