Enhancing Monoclonal Antibody Development:

How ARGEN Accelerates R&D in mAb Production

 

Recent research from the Journal of Pharmaceutical Sciences on stress factors in monoclonal antibody development underscores the critical need for robust control strategies in monoclonal antibody drug substance production. The paper focuses on the risks posed by various stress conditions during manufacturing.

These stressors can lead to protein modifications, impacting both patient safety and product quality. ARGEN, by Yokogawa Fluence Analytics, is a precision instrument that enhances monoclonal antibody development and accelerates biopolymer formulation studies. This is done by providing scientists with an in-situ, real-time, multi-stressor platform to evaluate aggregation, degradation, and the overall stability of biopolymers of all classes.

ARGEN’s capabilities include:

Real-Time Monitoring: ARGEN’s ability to monitor biopolymer stability in real time is invaluable for immediate feedback that can enhance monoclonal antibody development. While other instruments only provide a snapshot of the stability of a biopharmaceutical, ARGEN provides continuous, real-time data to help teams make informed decisions when protein modifications occur from a variety of manufacturing conditions.

Stress Modelling: ARGEN’s multi-stressor platform incorporates chemical, mechanical, and thermal stress testing on up to 16 sample cells simultaneously. ARGEN is adept at modelling the specific stressors encountered during mAb research & development, ensuring robust strategies for maintaining protein integrity.

Parallel Analysis and Time Efficiency: ARGEN’s parallel analysis configuration allows for rapid, comprehensive testing of mAb formulations under diverse conditions, accelerating the R&D process.

Comprehensive Insights: The versatility of ARGEN in assessing various stress conditions provides a holistic view that is advantageous for the optimization of mAb research & development processes. Biopharma teams can use ARGEN during several drug development stages, including pre-formulation, excipient selection, formulation development, validation, and long-term stability studies.

ARGEN’s advanced capabilities deliver a promising pathway to mitigate the risks associated with protein modifications during the production of monoclonal antibodies, ensuring higher quality and safety in the development of biotherapeutics.

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