Best Technology Application – ANALYTICAL
WINNER: High Throughput Glycosylation Analysis – Sciex
Business Application
There is a growing demand in the biopharmaceutical industry for high throughput and, large scale N-glycosylation profiling of therapeutic antibodies in all phases of product development, but especially during clone selection where hundreds of samples should be analyzed in a short period of time to assure their glycosylation based biological activity. Therefore development of a novel fully automatable protocol was necessary and the magnetic bead based protocol for N-glycosylation analysis of glycoproteins alleviated the hard-to-automate centrifugation and vacuum-centrifugation steps of the currently used protocols.
Short/Long Term Benefits
Automated liquid handling processing offered fast and precise sample preparation, reduced flow-induced shear strain on native biological sample matrices and minimized contamination risks. Fully automated sample preparation in this instance means no human intervention need from the beginning to the end of the sample preparation process. The approach was capable of large scale sample processing to accommodate rapid glycan analysis of therapeutic antibodies for the biopharmaceutical industry. In addition to the comparison of the glycosylation profile of an innovator drug to its biosimilar counterpart, the biological significance of the differences can also be addressed with the technology
Applying this magnetic bead based glycan sample preparation protocol with a laboratory automation workstation, a large number of samples can be processed in 96 well plate format within a couple hours requiring no centrifugation or vacuum-centrifugation steps.
FINALISTS
iLine F – OVIZIO
Business Application
The iLine F is a smart device for continuous real-time suspension cell monitoring in bioreactors or disposable bags, limiting the number of operations and improving reproducibility of the cell culture process. The automated system combined with the OsOne machine learning software offers user-independent reproducible quantitative 3D live cell imaging thanks to differential digital holography microscopy.
Short/Long Term Benefits
Existing offline manual sampling methods lead to high workload, variability and contamination risk. Differential Digital Holographic Microscopy is a new quantitative technique allowing automated cell counting as well as cell viability monitoring in a continuous, label-free set-up, eliminating the need of sampling (risk of contamination, workload and variability), staining and waiting for the results generated by an off-line counter. The iLine F is an innovative and efficient solution to comply with the PAT guidance from regulatory agencies. Cost comparison with traditional counters showed that the iLine system enables to decrease yearly operational costs by 40% for medium-sized facilities and up to 60% for large facilities. It can be used in R&D, process development and production.
BioLayer Interferometry (Octet) – Catalent Pharma Solutions
Business Application
The system defined is, essentially, a toolbox approach for assessing mAb/Fc receptor binding kinetics. The intent is to eventually use the analytical panel both for characterization of biosimilar molecules and comparison to originator molecules, as well as for CMC-related release and stability testing.
Short/Long Term Benefits
It is important to test therapeutic mAb for binding with the complete panel of human IgG-Fc-binding receptors for characterization of original therapeutics and/or testing of biosimilar mAbs. If the mAb is an effector mAb, then it is necessary to show consistency in binding to the high and low affinity receptors CD64, CD32 and CD16. If the mAb is a neutralizing moiety, only (no effector function), one might then expect altered binding, if any, to the Fc* receptors. However, all antibodies will bind in some fashion to the Fc* receptors. More importantly, all antibodies will bind to FcRN, which despite the name ‘neonatal’ is present in adult bone marrow-derived cells, as well as other tissue. It is essential that the established Fc Receptor panel test a) not require derivatization of the mAb (analyte), and b) be easily adaptable to other mAb’s.