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Adaptive Process Control and Advanced Sensing for Robust mAb Glycan Quality

The goal of this project is to implement enhanced glycan sensors with control algorithms to produce consistent, desirable glycosylation patterns to improve product quality of biotherapeutics.
Categories
Proteins/ Antibodies
Drug substance
Assays
Process control
Project status
100% Completed

Solution

Performance Period: 5/1/2018 to 10/31/2020

This work focuses on key post-translation modification impacting product quality of biotherapeutics, specifically the carbohydrate groups (glycans) that affect antibody function, stability, immunogenicity, and plasma half-life.

The goal of this multidisciplinary, multi-institute initiative is to implement enhanced glycan sensors with control algorithms to produce consistent, desirable glycosylation patterns. Lectin arrays generating quantitative electrical and fluorescence signals will be tested against antibody standards and samples from bioreactors and then integrated with nested glycan and nutrient control during fed-batch culture.

A bioprocess performance platform producing near real-time control of critical glycan attributes will be ready for pilot scale implementation by completion of the 18-month project.

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Project Lead

Carnegie Mellon University

Carnegie Mellon University

Participating Organizations

Johns Hopkins University

Johns Hopkins University

Tulane University

Tulane University

University of Delaware

University of Delaware

University of Maryland College Park

University of Maryland College Park