Global biotherapeutics company transforms mAb characterization and process development with 908 Devices’ point-of-need technologies
908 Devices (NASDAQ:MASS), a pioneer of purpose-built handheld and desktop mass spec devices for chemical and biomolecular analysis, today announced outcomes of its joint innovation partnership with Transcenta, a global biotherapeutics company. Transcenta has implemented 908 Devices’ technologies within its Process and Product Development Center and Manufacturing Facility in Hangzhou, China to facilitate their biopharma analytical workflows across large molecule characterization and formulation process development.
Rigorous characterization of biotherapeutics, and monoclonal antibodies in particular, is a challenging task in terms of ensuring safety, efficacy and potency of a therapeutic agent because of structural heterogeneity during cell culture, purification and storage.
908 Devices ZipChip®device enables the rapid measurement of Critical Quality Attributes (CQAs) of intact monoclonal antibodies (mAbs). Transcenta leveraged this platform to characterize intact mAbs and assess the root cause of increases in acidic and basic variants under stress at high temperature. The antibody was analyzed at multiple levels, including its intact state under native conditions, and subunit and peptide levels with the same device and method. ZipChip helped Transcenta to determine charge heterogeneity speciation and identification in under 10 minutes. This workflow is 100 times faster with fewer preparation requirements than conventional liquid chromatography methods (considering the step of harvesting fractions in traditional liquid chromatography methods). The company’s work with 908 Devices ZipChip platform resulted in a recent publication in the peer-reviewed journal, Analytical Biochemistry.
“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 Dr. Christopher Hwang, CTO of Transcenta. “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.”
Transcenta also has implemented 908 Devices’ REBEL®device, to accelerate media and process development, which is essential for its development of highly intensified continuous cell culture perfusion platform. Transcenta announced earlier this year that its continuous perfusion cell culture platform has achieved industry leading volumetric productivity of greater than 6 g/L PER day while maintaining process and product quality attributes in a state of control for a 4-week culture. REBEL has played an instrumental role in the group’s progress with amino acid analysis, and its ease of operation and small footprint has proved essential to its widespread implementation.
“REBEL can analyze a large number of samples in 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 leads 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. “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.”
908 Devices and Transcenta launched their partnership in mid-2018 and expanded the relationship in April 2020 to include the REBEL device – a first of its kind analyzer for at-line cell culture media analysis – to accelerate process development cycles and enhance the analytical lab’s productivity. ZipChip and REBEL have become a critical part of Transcenta’s analytical toolset, streamlining internal processes and enabling rapid measurement of CQAs, native proteins and small molecules.
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