ArticleThe AAPS journal2023
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point.
Article in The AAPS journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 15 citations in OpenAlex.
- A Review on Lymphatic Uptake of Large Therapeutic Proteins after Subcutaneous Injection.Pharmaceutical research · 2026Review
- Predicting Aberrant Fc-fusion Protein Pharmacokinetics from In Silico Structural Properties and Physiologically Based Pharmacokinetic (PBPK) Modeling.The AAPS journal · 2026Article
- Fifty years of monoclonals: the past, present and future of antibody therapeutics.Nature reviews. Immunology · 2025Article
- Rat as a Predictive Model for Human Clearance and Bioavailability of Monoclonal Antibodies.Antibodies (Basel, Switzerland) · 2024Article
- A Physiologically Based Pharmacokinetic Model Relates the Subcutaneous Bioavailability of Monoclonal Antibodies to the Saturation of FcRn-Mediated Recycling in Injection-Site-Draining Lymph Nodes.Antibodies (Basel, Switzerland) · 2024Article
- Human Dose and Pharmacokinetic Predictions for Biologics at Boehringer Ingelheim: A Retrospective Analysis.Advances in therapy · 2024Article
- Predicting Human Bioavailability of Subcutaneously Administered Monoclonal Antibodies Using Non-human Primate Linear Clearance and Antibody Isoelectric Point.The AAPS journal · 2023Article
- Review
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Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
There has been an increasing trend towards subcutaneous (SC) delivery of fusion proteins and monoclonal antibodies (mAbs) in recent years versus intravenous (IV) administration. The prediction of bioavailability is one of the major barriers in clinical translation of SC-administered therapeutic proteins due to a lack of reliable in vitro and preclinical in vivo predictive models. In this study, we explored the relationships between human SC bioavailability and physicochemical or pharmacokinetic properties of 19 Fc- or albumin-fusion proteins and 98 monoclonal antibodies. An inverse linear correlation was observed between human SC bioavailability and intravenous clearance (CL) or isoelectric point (pI). Multivariate regression models were developed using intravenous CL and pI of a training set (N = 59) as independent variables. The predictive models of mAbs were validated with an independent test set (N = 33). Two linear regression models resulted in 24 (73%) and 27 (82%) among 33 predictions within 0.8- to 1.2-fold deviations. Due to the small sample size of dataset, regression model validation was not conducted for fusion proteins. Overall, this study demonstrated that CL- and pI-based multivariate regression models could be used to predict human SC bioavailability of mAbs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.