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PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development
Inge A Ivens1, William Achanzar2, Andreas Baumann3
1Bayer HealthCare, San Francisco, California, USA inge.ivens@bayer.com.
Toxicologic Pathology
|August 5, 2015
Summary
PEGylation improves drug properties, with most adverse effects from the active drug, not polyethylene glycol (PEG). Cellular vacuolation is observed in toxicology studies but does not impact organ function.
Area of Science:
- Pharmaceutical Science
- Toxicology
- Biotechnology
Background:
- PEGylation is a common technology to enhance the properties of biopharmaceuticals.
- Eleven PEGylated biopharmaceuticals are approved, with more in development.
- Adverse effects are typically linked to the active molecule, not PEG.
Purpose of the Study:
- To assess the nonclinical safety of large polyethylene glycol (PEG) molecules in PEGylated biopharmaceuticals.
- To discuss the impact of PEG on safety assessments.
- To summarize toxicological data from an industry survey.
Main Methods:
- Review of toxicological data from industry surveys.
- Histological examination for cellular vacuolation.
- Analysis of adverse effects in PEGylated biopharmaceuticals.
Main Results:
- Cellular vacuolation observed in toxicology studies of some PEGylated biopharmaceuticals.
- Vacuolation primarily occurs in phagocytes and is not linked to organ dysfunction.
- No other adverse effects attributed solely to PEG have been reported.
Conclusions:
- Large PEG molecules in PEGylated biopharmaceuticals exhibit a generally favorable nonclinical safety profile.
- Cellular vacuolation is a notable but generally benign finding.
- Further data contributes to the understanding of PEG safety in drug development.
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