The Simoa system is ultra-sensitive, and capable of detecting and quantifying challenging biomolecules, making it well-suited to PK, ADA, and biomarker analysis. In this paper we describe Frontage's steps to ensure that it meets current regulatory requirements.

The emergence of global pandemics has led to an expansion of studies focused on vaccine development for infectious agents. Moreover, breakthroughs in understanding the immune system in recent years have brought a new wave of treatments using immune system modulators and immunotherapies. The ELISpot assay is a powerful tool in addressing the bioanalytical needs of vaccine development, immunotherapies, and gene therapies. Tremendous global harmonization efforts have been carried out to create optimized protocols and guidelines for ELISpot assays. Successes in these efforts are now being transferred to other areas in which there is an urgent need for compliant, high-throughput image acquisition and analysis systems.

A drug’s potency, which is a critical quality attribute, is determined by examining biological activity at the cellular level. Cell-based assays are available to measure this activity. However, selecting, developing, validating, and performing the appropriate assay demands highly-specialized expertise. This work should only be entrusted to GMP laboratories with considerable proven experience.