Biopharmaceutical manufacturers require accurate glycan profiling for monoclonal antibodies (mAbs) to ensure product quality and regulatory compliance. Traditional methods can be time-consuming and complex, limiting throughput and reproducibility. Industry needs rapid, high-throughput analytical platforms that can quantify glycans consistently across labs, reducing variability and accelerating process development.
Carnegie Mellon implemented glycan analysis using the PerkinElmer LabChip GXII Touch Protein Characterization System, which offers:
At project completion, the LabChip System will be available on a priority basis for NIIMBL-related technology and workforce activities, within any necessary constraints of the host institution, to be negotiated with NIIMBL.
Evaluate whether “community performance metrics” can be defined for NISTmAb released and/or released/labeled methods
Evaluate modes of implementation of a new quantitative glycan standard, SRM 3655
Understand if SRM 3655 can assist in harmonizing or standardizing glycan measurements
LabChip GXII Touch analysis achieved consistent glycan quantitation across triplicate runs, with minimal day-to-day variability. Absolute glycan amounts were benchmarked using NIST standards, supporting robust QC metrics. This approach can reduce glycan analysis turnaround time and improve inter-lab comparability.
Purchased and installed PerkinElmer LabChip GXII Touch system.
Completed glycan analysis of NISTmAb and 13 glycan calibrants in triplicate.
Generated reproducibility data for inter-lab benchmarking.
Delivered recommendations for future collaborative studies and orthogonal method integration.
Supported training for graduate and MS students in advanced glycan analysis workflows.
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Carnegie Mellon University
