Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look

Ling, Jie; Zhou, Honghui; Jiao, Qun; Davis, Hugh M.

doi:10.1177/0091270009337134

Cited by 144Monoclonal and Polyclonal Antibodies ResearchBiosimilars and Bioanalytical MethodsPharmaceutical studies and practices

Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look

Ling, Jie, Zhou, Honghui, Jiao, Qun, Davis, Hugh M.·2009·The Journal of Clinical Pharmacology

DOI 10.1177/0091270009337134

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Abstract

The authors evaluated interspecies scaling for the prediction of human clearance of 18 therapeutic monoclonal antibodies (mAbs). Human and monkey/chimpanzee data of 14 mAbs were classified based on the targeted antigens (soluble or membrane bound). Simple allometry and/or a time‐invariant method (elementary Dedrick plot) were performed. Results indicate that human clearance might be accurately predicted from monkey data for mAbs targeting soluble receptors or membrane‐bound receptors with limited tissue distribution using simplified allometry. The optimal exponents were estimated to be 0.85 or 0.90. If nonlinearity is anticipated at the human efficacious dose, pharmacokinetic parameters obtained at high doses in animals might not be sufficient for full pharmacokinetic characterization and prediction. Using prespecified criteria, including predicted human clearance (≤ or > 10 mL/d/kg), simplified allometric scaling might be helpful in predicting the effect of receptor‐mediated clearance for mAbs targeting membrane‐bound antigens. Furthermore, simplified allometry and an elementary Dedrick plot provide similar results in predicted clearance. Given the significant advantages offered by simplified allometry, it should be used when data are available from only 1 species. When reasonable data from ≥3 species are available, traditional allometry should be explored. Overall, clearance prediction is useful for human dose prediction in drug discovery and development.

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The practice of projecting mAb PK in humans is well established.
“The practice of projecting mAb PK in humans is well established,63, 64, 65, 66, 67”
From Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development (2018) · cites this paper as [64]
Two general approaches for antibodies with linear PK are commonly used to project mAb PK in humans.
“two general approaches for antibodies with linear PK are commonly used.”
From Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development (2018) · cites this paper as [64]

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Authors: Ling, J., Zhou, H., Jiao, Q., & Davis, H. M.
Corresponding author: Ling, Jie
ORCID: Ling, Jie
Zhou, Honghui
Venue: The Journal of Clinical Pharmacology
Publisher: Wiley
Published: 2009-12
Volume: 49
Issue: 12
Pages: 1382-1402
ISSN: 0021-9754 (ISSN-L)
0091-2700
1552-4604
DOI: 10.1177/0091270009337134
OpenAlex: W2011077241
Cited by: 144
References: 68
Citations by year: 2026: 4 · 2025: 4 · 2024: 15 · 2023: 5 · 2022: 7 · 2021: 10 · 2020: 6 · 2019: 8 · 2018: 6 · 2017: 9 · 2016: 10 · 2015: 14 · 2014: 11 · 2013: 11 · 2012: 10
FWCI: 1.15
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor, 1192 d)
Locations: The Journal of Clinical Pharmacology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords: interspecies scaling, therapeutic monoclonal antibodies, soluble receptor, cell surface receptors, receptor-mediated clearance
MeSH terms: Animals, Antibodies, Monoclonal, Humans, Metabolic Clearance Rate, Species Specificity, Models, Animal

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Interspecies Scaling of Therapeutic Monoclonal Antibodies: Initial Look

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