Panel Presentation: N-GLYcanyzer: An Automated Process Analytical Platform To Enable Continuous Manufacturing Of Biologics

The biopharmaceutical industry is transitioning towards continuous biomanufacturing processes that require advanced analytical tools to monitor and control bioprocesses to produce high-quality biologics. Post-translational modification of therapeutic proteins, such as N-linked glycosylation, are critical quality attributes (CQA) that affect biologics safety and efficacy, requiring close monitoring during biomanufacturing. The Chundawat group at Rutgers University has developed an automated analytical toolkit (called the N-GLYcanyzer) to monitor and control protein N-glycosylation during biologics manufacturing in near real-time (1-2). Here we highlight the key enabling features of this toolkit and provide examples of its use for monitoring a continuous upstream mammalian cell culture process for producing a commercially relevant Trastuzumab biosimilar with the desired CQA.

Learning Objectives:

1. Define what is Process Analytical Technology (PAT).

2. Explain and describe the influence of N-glycosylation as a post-translational modification for biotherapeutics.

3. Explain how glycans alter therapeutic efficacy.

4. Explain some ways that glycosylation can be altered during bioprocessing.