Challenges in the subcutaneous (SC) administration of monoclonal antibodies (mAbs)

Shire, Steven J.

doi:10.1016/b978-0-08-100296-4.00006-3

Cited by 2 publications

(1 citation statement)

References 24 publications

(22 reference statements)

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“…In general, the bioavailability of mAbs after a subcutaneous administration is incomplete because of presystemic catabolism at subcutaneous administration site and/or systemic catabolism in draining lymphatics and blood vessels [30]. Variability between patients related to the subcutaneous layer morphology, the depth of the injections, molecular properties of the mAbs, stability of the mAbs, and mAb formulation are other cited factors that govern the bioavailability of mAbs when they are administered subcutaneously [31].…”

Section: Absorptionmentioning

confidence: 99%

Monoclonal antibodies for severe asthma: Pharmacokinetic profiles

Matera

Calzetta

Rogliani

et al. 2019

Respiratory Medicine

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Several monoclonal antibodies (mAbs) (omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab) are currently approved for the treatment of severe asthma. They have complex pharmacokinetic profiles. These profiles are unique in that they are dependent on their structure as well as can be markedly influenced by the biology of their target antigen, but their general behaviour can still be considered a class property, similar to their endogenous IgG counterpart. They cannot be administered by oral route, have a slow distribution into tissue, are metabolized to peptides and amino acids in several tissues but are protected from degradation by binding to protective receptors (the FcRn), which explains their long elimination half-lives. Their clearance is nonlinear because of the saturation of the target-mediated elimination. Also anti-drug antibody (ADA) response and off-target binding, as well as their glycosylation pattern, can influence the pharmacokinetics of mAbs.

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Section: Absorptionmentioning

confidence: 99%

Monoclonal antibodies for severe asthma: Pharmacokinetic profiles

Matera

Calzetta

Rogliani

et al. 2019

Respiratory Medicine

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Enhancing the Injectability of High Concentration Drug Formulations Using Core Annular Flows

Jayaprakash

Costalonga

Dhulipala

2020

Adv Healthcare Materials

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Highly concentrated biological drug formulations would offer tremendous benefits to global health, yet they cannot be manually injected using commercial syringes and needles due to their high viscosities. Current approaches to address this problem face several challenges such as crosscontamination, high cost, needle clogging, and protein inactivation. This work reports a simple method to enhance formulation injectability using a core annular flow, where the transport of highly viscous fluids through a needle is enabled by coaxial lubrication by a less viscous fluid. A phase diagram to ensure optimally lubricated flow while minimizing the volume fraction of lubricant injected is established. The technique presented here allows for up to a 7x reduction in injection force for the highest viscosity ratio tested. The role of buoyancy‐driven eccentricity in governing nominal pressure reduction is also examined. Finally, the findings are implemented into the development of a double barreled syringe that significantly expands the range of injectable concentrations of several biologic formulations.

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Challenges in the subcutaneous (SC) administration of monoclonal antibodies (mAbs)

Cited by 2 publications

References 24 publications

Monoclonal antibodies for severe asthma: Pharmacokinetic profiles

Monoclonal antibodies for severe asthma: Pharmacokinetic profiles

Enhancing the Injectability of High Concentration Drug Formulations Using Core Annular Flows

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