Improving Efficiency & Data Accuracy in Biopharmaceutical Stability Testing with ARGEN’s Simultaneous Multi-Sample Light Scattering
In the fast-paced world of biopharmaceutical research and development, precision and efficiency are not just goals—they are imperative. Amidst the complex challenges faced by scientists, the ability to swiftly and accurately gauge the stability of formulations can significantly expedite the formulation development process and enhance the quality of final products before going to clinical trials.
The ARGEN platform is built upon patented, simultaneous multiple sample light scattering (SMSLS) technology, distinguishing it as the sole light scattering instrument capable of conducting up to 16 parallel static light scattering measurements. This functionality is akin to operating 16 individual static light scattering units simultaneously, all within a single device. Each cell offers independent temperature settings for static and ramping modes.
A standout feature of ARGEN is the ability to interchange samples mid-experiment without affecting the ongoing data collection in other cells. This flexibility extends to on-the-fly adjustments such as dilutions, titrations, and changes in pH, salts, and excipients. Traditional systems rely on well plate technology that requires serial data acquisition, a process that becomes particularly time-consuming, depending on the experimental parameters and the kinetic properties of the target biopolymer.
Moreover, ARGEN’s stationary cells eliminate the detrimental effects associated with the mechanical movements of plate reading devices. These movements can significantly influence the total light intensity measurements due to even minimal positional differences. Unlike well plate technologies, which may work for dynamic light scattering (DLS) and fluorescence measurements, ARGEN excels in static light scattering, where precision is critical.
Another innovative aspect of ARGEN is its capacity to simulate mechanical stress typical of bioprocessing environments. Each of the 16 cells is equipped with a stepper motor-driven micro stir bar, facilitating the study of mechanical agitation effects, a critical concern in biopharmaceutical research for assessing manufacturability.
The comprehensive capabilities of ARGEN are evidenced by its unparalleled performance in real-time monitoring of 16 independent samples undergoing dynamic processes such as aggregation, degradation, phase transitions, and dissolution kinetics. The ARGEN-LT system, which has an 8-cell configuration, offers a thermal range from 3°C to 100°C, making it ideal for prolonged, in situ studies needed for assessing lower-temperature shelf-life.
ARGEN’s unique capabilities have been crucial for a leading US pharmaceutical company, puzzled by the instability of their products despite employing a team of top-tier Ph.D. scientists and advanced analytical tools. The capabilities of ARGEN allowed us to precisely identify and address the root causes of their issues.
Connect with Yokogawa Fluence Analytics Today!