ArticlemAbs
Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 68 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
68 citing papers in PubMed, 138 citations in OpenAlex.
- Near UV and Visible Light-Induced Degradation of IgG2: Photo-Fenton Reaction in Citrate Buffer.Pharmaceutical research · 2026Article
- Quantitative Prediction of Human Pharmacokinetics for Fc-Engineered Therapeutic Monoclonal Antibodies With Increased FcRn Binding Mutations After Subcutaneous Injection.Clinical and translational science · 2026Article
- Human and porcine IgG subclasses differentially engage porcine Fc receptors.Discovery immunology · 2026Article
- Hybrid mechanistic-machine learning PK/PD models with digital biomarkers: from cage to clinic.Frontiers in pharmacology · 2026Review
- Immunoglobulin G Fc engineering for localized therapy: Eliminating neonatal Fc receptor interactions and ensuring purification using protein A.Protein science : a publication of the Protein Society · 2025Article
- Assessment of Minipigs as a Non-clinical Model for Screening and Derisking Injection Site Reactions in Clinical Trials.Pharmaceutical research · 2025Article
- Rat as a Predictive Model for Human Clearance and Bioavailability of Monoclonal Antibodies.Antibodies (Basel, Switzerland) · 2024Article
- Development and Evaluation of Five-in-One Vaccine Microneedle Array Patch for Diphtheria, Tetanus, Pertussis, Hepatitis B, andPharmaceutics · 2024Article
- A minimal physiologically based pharmacokinetic model to study the combined effect of antibody size, charge, and binding affinity to FcRn/antigen on antibody pharmacokinetics.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- A pilot pharmacokinetic and Metabolite identification study of Erinacine A in a Single landrace pig model.Heliyon · 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
- Comparative pharmacokinetics of porcine and human anti-influenza hemagglutinin monoclonal antibodies in outbred pigs and minipigs.Frontiers in immunology · 2024Article
- Article
- A Quantitative Prediction Method for the Human Pharmacokinetics of Fc-Fusion Proteins.European journal of drug metabolism and pharmacokinetics · 2023Article
- Characterization of large volume subcutaneous injections using computed tomography imaging and simultaneous pressure measurements.Frontiers in drug delivery · 2023Article
- Monoclonal Antibody Pharmacokinetics in Cynomolgus Monkeys Following Subcutaneous Administration: Physiologically Based Model Predictions from Physiochemical Properties.The AAPS journal · 2022Article
- Characterization of a new potent and long-lasting single chain peptide agonist of RXFP1 in cells and in vivo translational models.Scientific reports · 2022Article
- Review of the Existing Translational Pharmacokinetics Modeling Approaches Specific to Monoclonal Antibodies (mAbs) to Support the First-In-Human (FIH) Dose Selection.International journal of molecular sciences · 2022Review
- Mathematical Models to Characterize the Absorption, Distribution, Metabolism, and Excretion of Protein Therapeutics.Drug metabolism and disposition: the biological fate of chemicals · 2022Review
- Targeting tau only extracellularly is likely to be less efficacious than targeting it both intra- and extracellularly.Seminars in cell & developmental biology · 2022Review
8 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
31 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Subcutaneous (SC) delivery is a common route of administration for therapeutic monoclonal antibodies (mAbs) with pharmacokinetic (PK)/pharmacodynamic (PD) properties requiring long-term or frequent drug administration. An ideal in vivo preclinical model for predicting human PK following SC administration may be one in which the skin and overall physiological characteristics are similar to that of humans. In this study, the PK properties of a series of therapeutic mAbs following intravenous (IV) and SC administration in Göttingen minipigs were compared with data obtained previously from humans. The present studies demonstrated: (1) minipig is predictive of human linear clearance; (2) the SC bioavailabilities in minipigs are weakly correlated with those in human; (3) minipig mAb SC absorption rates are generally higher than those in human and (4) the SC bioavailability appears to correlate with systemic clearance in minipigs. Given the important role of the neonatal Fc-receptor (FcRn) in the PK of mAbs, the in vitro binding affinities of these IgGs against porcine, human and cynomolgus monkey FcRn were tested. The result showed comparable FcRn binding affinities across species. Further, mAbs with higher isoelectric point tended to have faster systemic clearance and lower SC bioavailability in both minipig and human. Taken together, these data lend increased support for the use of the minipig as an alternative predictive model for human IV and SC PK 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.