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Subcutaneous delivery of monoclonal antibodies: How do we get there?

08:00 EDT 2nd August 2018 | BioPortfolio

Summary of "Subcutaneous delivery of monoclonal antibodies: How do we get there?"

The convenience of subcutaneous (SC) administration and the increase of monoclonal antibodies (mAbs) being studied for chronic diseases disclose that their potential to be delivered through SC injection is likely to continue to grow in the next years. In addition, there is a common interest among patients, clinicians and pharmaceutical industry in moving from intravenous to SC administration of mAbs due to benefits of improved patient compliance and reduced costs to the healthcare system. Despite the wide use of this route of administration in diseases like diabetes and rheumatoid arthritis, SC bioavailability of mAbs has been shown to be incomplete and variable in most preclinical and clinical studies. This evidences some gaps about the understanding of SC absorption process of mAbs and their drug development process. Likewise, challenges present in drug formulation, such as high viscosity and aggregation, and the inherent immunogenicity of mAbs have also been hampering the successful clinical application of SC administration of these drugs. This review provides a characterization of the subcutaneously delivered mAbs that had entered the market in the last 10 years as well as a snapshot of the landscape of currently undergoing clinical trials. Moreover, there is an overview of the factors influencing SC absorption of mAbs and the preclinical models in use to study SC pharmacokinetics. Considerations about drug formulation and immunogenicity of mAbs are also explored.

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This article was published in the following journal.

Name: Journal of controlled release : official journal of the Controlled Release Society
ISSN: 1873-4995
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Medical and Biotech [MESH] Definitions

Antibodies obtained from a single clone of cells grown in mice or rats.

Antibodies produced by clones of cells such as those isolated after hybridization of activated B LYMPHOCYTES with neoplastic cells. These hybrids are often referred to as HYBRIDOMAS.

Antibodies from non-human species whose protein sequences have been modified to make them nearly identical with human antibodies. If the constant region and part of the variable region are replaced, they are called humanized. If only the constant region is modified they are called chimeric. INN names for humanized antibodies end in -zumab.

Antibodies, often monoclonal, in which the two antigen-binding sites are specific for separate ANTIGENIC DETERMINANTS. They are artificial antibodies produced by chemical crosslinking, fusion of HYBRIDOMA cells, or by molecular genetic techniques. They function as the main mediators of targeted cellular cytotoxicity and have been shown to be efficient in the targeting of drugs, toxins, radiolabeled haptens, and effector cells to diseased tissue, primarily tumors.

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