Biopharmaceutical companies are experiencing greater demand to develop novel biologic therapeutics in less time, and this requires a paradigm shift in the way teams approach formulation development efforts. Most analytical tools used to monitor biopolymer stability only provide a periodic “snapshot” of solution behavior at a specific time point. There is a need for analytical tools, like ARGEN, to rapidly understand biopolymer stability under various conditions in real time, accelerating the development of novel biotherapeutics.
ARGEN and ARGEN-LT are high throughput biotechnology instruments designed for the rapid or long-term assessment of the stability and viability of proteins, peptides and other biopolymers. The instruments include intuitive data processing packages and a multi-stressor platform that is powered by static light scattering detection. These features enable teams to expedite the development and validation of biologic formulations.
Fluence Analytics recently announced the addition of ARGEN-LT to its biopharma applications product portfolio. ARGEN-LT is suitable for thermal stability studies from 0⁰C-100⁰C, making it an ideal instrument to determine viability and shelf-life at low temperature(s). The device is engineered with eight sample cells, permitting the user to establish thermal and mechanical (stirring) stress parameters on each sample at the same time and independently. Data generated using the instrument provides quantitative and qualitative insights into the early detection of aggregation and degradation, which saves discovery and formulation development teams valuable time and resources.
ARGEN and ARGEN-LT utilize fixed angle (90°), SMSLS (simultaneous multiple sample light scattering) technology which provides rapid, real-time, continuous data collection for characterizing qualitative and quantitative properties of target molecules. Both devices are equipped with independently controlled sample cells, permitting the user to conduct thermal, mechanical or chemical stress experiments on each sample concurrently. ARGEN, designed with 16 sample cells, is well-suited for isothermal or temperature ramping experiments from 18⁰C-100⁰C. This allows for a highly flexible approach to experimental design.
Up to 16-fold reduction in time and resources required to identify optimal target formulations.
Continuous and flexible operation for temporal stability studies and establishing shelf-life
Matrix DOE capability for rapid screening of thermal, chemical, and mechanical stress impacts
Proprietary control and analysis software with intuitive interface for all aspects of experimental design and independent control of cells