Colloidal stability characterization is key to creating effective and safe protein-based therapeutics. To be sustainable, the target biotherapeutic must remain stable during production, storage, and patient delivery.
Image Credit: Yokogawa Fluence Analytics
Successful monitoring and characterization methods for colloidal stability involve in situ and real-time analysis under modeled stress conditions. This enables real-time analysis of sample solution behavior in response to stressors without extrinsic perturbation.
A biopolymer sample is often exposed to a stressor before an aliquot is removed for further investigation. Sample transfer to an analysis vessel may disrupt loosely associated aggregates, inhibiting accurate representation.
The size exclusion chromatography (SEC) technique determines particle size distributions upon experiment completion. However, it cannot successfully monitor the formation of higher-order species and aggregates or degradation in real-time.
Shear forces generated throughout elution and nonspecific interactions with resin may also influence native solution behavior, preventing accurate delineation.
ARGEN™ confronts biopharmaceutical research challenges by enabling in situ, real-time colloidal stability monitoring, manufacturing stress modeling, shelf-life determination, and rapid parallel analysis.
This new tool improves formulation development efficiency while ensuring the final therapeutic product’s quality and stability.
Real-time stability monitoring
One of AGEN’s core features is the real-time monitoring of biopolymer colloidal stability. Conventional approaches often necessitate post-stress analysis, which might not accurately capture the dynamic processes of aggregation and degradation as they happen.
ARGEN delivers instant feedback on these critical stability parameters, enabling rapid adjustments during formulation development. This capability is key in decreasing stable formulation development time, a significant benefit for biopharmaceutical companies aiming to get their biologics to market quicker.
Oligomerization kinetics
Understanding biopolymer behavior, especially their transition between oligomeric states such as monomer to dimer, is critical for predicting performance in therapeutic operations.
ARGEN evaluates these transitions in real time to provide critical insight into biopolymer kinetics over traditional approaches like gel permeation chromatography. This knowledge assists in developing stable and effective formulations under physiological conditions.
Bioprocessing stress modeling
Biopolymers are exposed to numerous stress environments throughout bioprocessing, including shear mechanical and thermal stress.
ARGEN’s versatile platform, with several independently controlled cells for accurate modeling of these stressors, enables biopolymer formation to withstand such environments without sacrificing therapeutic stability or efficacy.
This feature is especially useful for guaranteeing biopolymer stability during production, storage, and drug delivery.
Parallel analysis and low-temperature analysis
Analyzing several samples concurrently in an experimental design format significantly accelerates formulation development. ARGEN’s parallel analysis capability considerably lowers the time needed to detect optimum formulations.
ARGEN’s capacity to examine samples at low temperatures is crucial for evaluating biopolymer stability for cold storage, ensuring they keep their therapeutic properties over time.
Versatility and impact on R&D
ARGEN’s adaptability extends beyond formulation development to pre-formulation studies, excipient selection, formulation development and optimization, analytical development and validation, and stability studies.
ARGEN complements numerous analytical techniques, including size exclusion chromatography, native polyacrylamide gel electrophoresis, dynamic light scattering, and Raman spectroscopy. This technique enables a comprehensive understanding of biopolymer behavior under diverse conditions, simplifying R&D.
Its time-saving advantages equate to having up to multiple individual static light scattering instruments in one, accelerating formulation development, enabling faster iterations and quicker market entry of novel biologics.
Integrating ARGEN into the R&D of protein-based therapeutics is a major development in the industry.
ARGEN addresses the key demands in biopolymer formulation R&D by providing real-time data insights into stability, facilitating the modeling of bioprocessing stress, and enabling rapid parallel analysis. This creates more stable, effective, reliable therapeutics and improved patient outcomes.
About Yokogawa Fluence Analytics
Yokogawa Fluence Analytics, which was named as a Top 50 global advanced manufacturing startup by CB Insights, provides patented process analytics and control solutions to polymer and biopharmaceutical customers worldwide. Yokogawa Electric Corporation acquired Fluence Analytics in January 2023.
Yokogawa Fluence Analytics is a global leader in real-time polymer reaction monitoring and control, and its industry-leading ACOMP product is the only commercially available smart manufacturing system that continuously monitors and measures polymerization reactions.
The company’s biopharmaceutical product line includes a high-throughput static light scattering instrument called ARGEN. ARGEN can independently measure the stability of biopolymers under thermal, chemical, and mechanical (physical) stress, while also performing shelf-life stability studies at low temperatures.
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