Pharmacokinetic de-risking tools for selection of monoclonal antibody lead candidates
Open accessAbstract
Pharmacokinetic studies play an important role in all stages of drug discovery and development. Recent advancements in the tools for discovery and optimization of therapeutic proteins have created an abundance of candidates that may fulfill target product profile criteria. Implementing a set of in silico, small scale in vitro and in vivo tools can help to identify a clinical lead molecule with promising properties at the early stages of drug discovery, thus reducing the labor and cost in advancing multiple candidates toward clinical development. In this review, we describe tools that should be considered during drug discovery, and discuss approaches that could be included in the pharmacokinetic screening part of the lead candidate generation process to de-risk unexpected pharmacokinetic behaviors of Fc-based therapeutic proteins, with an emphasis on monoclonal antibodies.
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Dostalek et al. summarized the various in silico, in vitro, and in vivo tools in predicting PK liability of lead candidates.
“A comprehensive review by Dostalek et al. summarized the various in silico, in vitro, and in vivo tools in predicting PK liability of lead candidates.59”
From Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development (2018) · cites this paper as [59]
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References 75 · Cited by 45
Research works printed but not linked: 1
- Prueksaritanont T, Tang C. ADME of Biologics-What Have We Learned from Small Molecules? AAPS J. 2012; 14(3):410-9; PMID:22484625
- Authors
- Dostalek, M., Prueksaritanont, T., & Kelley, R. F.
- Affiliations
- Drug Metabolism and Pharmacokinetics, Global Nonclinical Development, Shire, Lexington, MA, USA
- Chulalongkorn University (TH)
- Genentech (US)
- Corresponding author
- Kelley, Robert F.
- Venue
- mAbs
- Publisher
- Informa UK Limited
- Published
- 2017-05-02
- Volume
- 9
- Issue
- 5
- Pages
- 756-766
- ISSN
- 1942-0862 (ISSN-L)
- 1942-0870
- PMC
- PMC5524161
- OpenAlex
- W2610167700
- Cited by
- 45
- References
- 75
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 4 · 2023: 5 · 2022: 6 · 2021: 7 · 2020: 4 · 2019: 2 · 2018: 8 · 2017: 2
- FWCI
- 0.66
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- mAbs (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Genentech
- UCB Pharma
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
- Keywords
- monoclonal antibodies, lead candidate selection, virtual screening, in vitro screening, in vivo screening, target product profile, drug discovery, therapeutic proteins
- MeSH terms
- Animals, Antibodies, Monoclonal, Computer Simulation, Humans, Immunoglobulin Fc Fragments, Drug Discovery
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