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Following a deal struck in mid-2018, 908 Devices’ ZipChip and REBEL technology have proven instrumental in facilitating Transcenta’s efficiency and volumetric production.
The innovation deal between 908 Devices and Transcenta in mid-2018 has materialized into concrete improvements in workflow efficiency. By utilizing 908 Devices’ technologies at their manufacturing facility in Hangzhou, China, Transcenta has been able to facilitate their biopharma analytical workflows across large molecule characterization and formulation process development.
908 Devices’ ZipChip enables the rapid measurement of critical quality attributes (CQAs) of intact monoclonal antibodies (mAbs). By utilizing this technology, Transcenta was able to characterize intact mAbs and determine what was causing increases in acidic and basic variants when placed under stress at high temperatures. The antibodies were similarly analyzed in their intact state under native conditions as well as their subunit and peptide levels. Ultimately, the analysis helped determine heterogeneity speciation and identification in under ten minutes, which resulted in a workflow that was 100 times faster for Transcenta.
“Technologies offered by 908 Devices enabled us to quickly obtain high-quality analytical data to help accelerate development of innovative biologics to ultimately reach patients sooner. Our recently published results demonstrate the positive impact,” said Christopher Hwang, chief technology officer of Transcenta, in a press release from July 22, 2021. “ZipChip is a capable platform for multiple CQA assays, and, for charge variant analysis, it is very straightforward to get separation and identification information with minimal method development needed for different types of proteins, especially for the analysis in native conditions. The sample preparation is simple and straightforward, and the sample requirements are at nanogram level.”
In addition to the ZipChip, Transcenta also found success with 908 Devices REBEL technology. REBEL is designed to accelerate media and process development, both of which are critical in the development of highly intensified continuous cell culture perfusion platforms. REBEL was instrumental in getting Transcenta to a point where its volumetric production rate rose to more than 6 g/L per day. More specifically, it was crucial in their amino acid analysis.
“REBEL can analyze a large number of samples in a short period of time to provide valuable data to accelerate cell culture process development,” continued Hwang. “Rather than obtaining amino acid profiles after the run is completed, REBEL can provide near real-time data for us to make process decisions while the experiments are in progress to maximize successful outcomes.”
“The pharmaceutical industry recognizes that enhanced process understanding and control lead to improved yields and predictability. Our ZipChip and REBEL products enable that understanding by making bioanalysis fast and accessible,” said Kevin J. Knopp, CEO and co-founder of 908 Devices, in the press release. “The outcomes of our collaboration with Transcenta are encouraging and serve as a beachhead for our expanding work in the Asia Pacific region. We’re proud of the successful work and discoveries developing from the use of our products in this region.”
Source: 908 Devices