Epitope Profiling of Diphtheria Toxoid Provides Enhanced Monitoring for Consistency Testing during Manufacturing...

Area of Science:

• Vaccinology
• Immunochemistry
• Analytical Chemistry

Background:

• Vaccine manufacturing relies on diverse analytical methods for quality control.
• Ensuring consistency during manufacturing process changes is critical for vaccine efficacy and safety.

Purpose of the Study:

• To introduce and qualify the Single Epitope Antigenicity Test (SEAT) for diphtheria toxoid (DTxd) antigenicity assessment.
• To utilize SEAT for evaluating the impact of manufacturing process changes on DTxd antigenicity.

Main Methods:

• Employed BioLayer Interferometry (BLI) with a panel of monoclonal antibodies (mAbs).
• Assessed nine individual antigenic sites on DTxd, distinguishing intact from heat-treated forms.
• Qualified the SEAT method for precision, accuracy, and linearity.

Main Results:

• Defined a preliminary comparability range for current manufacturing process DTxd.
• Assessed DTxd lots from alternate processes against this range.
• Demonstrated SEAT's ability to quantitatively assess the integrity of multiple DTxd antigenic regions.

Conclusions:

• SEAT provides valuable quantitative epitope profiling for DTxd.
• This method supports comprehensive analytical testing for vaccine manufacturing process changes.
• SEAT is a key tool for ensuring vaccine quality and consistency.