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The ELISA Detectability and Potency of Pegfilgrastim Decrease in Physiological Conditions: Key Roles for Aggregation

Tao Xie¹, Hui Fang¹, Weiming Ouyang¹

¹Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.

Scientific Reports

|February 14, 2020

Summary

This summary is machine-generated.

Pegylated G-CSF (pegfilgrastim) biosimilar development faces challenges due to aggregate formation and detection variability. Understanding these factors is crucial for accurate pharmacokinetic assessments and successful biosimilarity studies.

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Area of Science:

Biopharmaceuticals
Pharmacokinetics
Drug Development

Background:

Pegylated recombinant human granulocyte colony stimulating factor (pegfilgrastim) is vital for immune reconstitution post-chemotherapy.
Biosimilar development for pegfilgrastim requires establishing pharmacokinetic (PK) similarity, complicated by inherent PK variability.
Pegfilgrastim can form aggregates in vitro under physiological conditions, impacting its bioactivity and detection.

Purpose of the Study:

To investigate the impact of pegfilgrastim aggregate formation on detection methods.
To assess the variability in pegfilgrastim stability and detectability in human sera.
To identify key factors influencing serum pegfilgrastim measurements for biosimilar development.

Main Methods:

Utilized SDS-PAGE, size-exclusion chromatography, dynamic light scattering, and real-time NMR to characterize pegfilgrastim aggregates.
Employed ELISA kits to evaluate detection capacities for pegfilgrastim and its aggregates.
Analyzed pegfilgrastim stability and concentration in human sera from healthy donors at 37°C.

Main Results:

Commercially available ELISA kits exhibit differential capacities in detecting pegfilgrastim aggregates.
Pegfilgrastim aggregates are associated with reduced bioactivity, including decreased cellular proliferation and STAT3 phosphorylation.
Significant inter-individual variability in pegfilgrastim stability and serum levels was observed, mirroring filgrastim stability patterns.

Conclusions:

Individual variability in pegfilgrastim stability and ELISA specificity for inactive aggregates are critical considerations.
These factors significantly influence the design and interpretation of studies measuring serum pegfilgrastim concentrations.
Addressing these challenges is essential for successful pegfilgrastim biosimilar development and accurate PK assessment.