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.
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In this webinar, speaker Christopher Gilmer introduces microbiological testing for raw materials, APIs, and finished products, discusses the validation of methods and product testing requirements, and clarifies general procedures to investigate unexpected results.
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.
The purpose of this study was to develop a better model to improve the quality of ddPCR assay validation, involving how to improve the reliability of accuracy, precision, and sensitivity.