Aron Gyorgypal

Harvard Medical School | HMS

Continuous bioprocessing is significantly changing the biological drugs or biologics manufacturing landscape by potentially improving product quality, process stability and/or overall profitability, as similarly seen during adoption of advanced manufacturing processes for small molecule drugs in the past decade. However, implementation of continuou...

With the transition toward continuous bioprocessing, process analytical technology (PAT) is becoming necessary for rapid and reliable in-process monitoring during biotherapeutics manufacturing. Bioprocess 4.0 is looking to build an end-to-end bioprocesses that includes PAT-enabled real-time process control. This is especially important for drug pro...

Monoclonal antibodies (mAbs) represent a majority of biotherapeutics on the market today. These glycoproteins undergo post-translational modifications, such as N-linked glycosylation, that influence the structural & functional characteristics of the antibody. Glycosylation is a heterogenous post-translational modification that may influence therape...

N-glycosylation is a post-translational modification that occurs during the production of monoclonal antibody (mAb) therapeutics. During production of mAb based therapeutics the use of various hosts and cell culture additives attribute to glycan heterogeneity. The safety and efficacy of monoclonal antibodies with mechanism of actions that utilize F...

With the transition toward continuous bioprocessing, Process Analytical Technology (PAT) is becoming necessary for rapid and reliable in-process monitoring during biotherapeutics manufacturing. Bioprocess 4.0 is looking to build end-to-end bioprocesses...

Post-translational modification such as N-Glycosylation on biologics during the production of monoclonal antibody (mAb) based therapeutics is a critical quality attribute that dictates safety and efficacy. Variability is introduced in the cell culture process which influences, the glycosylation pattern which is known to be highly heterogenous and m...

The biopharmaceutical industry is transitioning towards adoption of continuous biomanufacturing practices that are often more flexible and efficient than traditional batch processes. Regulatory agencies such as the Food and Drug Administration (FDA) are further urging use of advanced PAT to analyze the design space to increase process knowledge and...