Continuity of Methods: Characterizing Protein Therapeutic Stability From Developability Assessment to Release With Aura PTx
Bernardo leads application and business development and is one of Halo Labs’ founders. He was previously CEO and CTO and played a pivotal role in bringing over $6M in federal grant funding. Prior to starting Halo Labs, Bernardo was a Postdoctoral Associate at Cornell University, where he also obtained his M.S. and PhD. degrees in Mechanical Engineering. His wide range of technical experience includes particle analysis, detection and manipulation, drug delivery devices, microfluidics, nanophotonics and bioenergy production. In 2012, Bernardo was named one of Philadelphia’s top 30 under 30 entrepreneurs, the same year Halo Labs was named Philadelphia Life Science Startup of the year by the Greater Philadelphia Alliance for Capital and Technologies.
About this event:
Date: March 10, 2022
Time: 11 am EST | 8 am PST | 5 pm CET
Duration: 15 minutes
Aura PTx is a complete protein therapeutic stability solution that enables characterization of subvisible particle aggregates from developability assessment through product release. Aura PTx is a high throughput analytical instrument that images, counts, sizes, and identifies subvisible particle aggregates, a critical quality attribute and the most important biologic stability parameter. Using volumes as low as 10 µL and with measurements of one minute per sample, Aura PTx enables rapid, highly contrast and thorough subvisible particle screening and absolute particle quantification.
In addition, it is powered by fluorescence membrane microscopy, a proprietary technique than enables individual particle identification analysis, which is helpful to identify and segment particles as protein aggregates, degraded polysorbate particles and other particulate impurities relevant to protein therapeutic development.
In this talk, we overview ability to perform subvisible particle analysis from cell line development through developability assessment, into product development and release as it is USP 1788 Method 2 compliant.