Today, escalating production costs and a decrease in investment returns are the two major obstacles faced by pharmaceutical companies. To stabilize the rising costs and deliver reliable and accurate results, quality and speed are two key aspects that need attention. Although manual assays are the backbone of biomarker assay development and validation, automation will be a crucial factor for accelerating bioanalytical testing.
Ensuring high-quality fit-for-purpose immunoassay
Data suggests inconsistent reagent and method performance, matrix interference, data quality coupled with lengthy method development are some limitations faced with ligand-binding assays. For a successful assay method development and validation, it is necessary to develop a fit-for-purpose immunoassay that readily fulfills the minimal acceptance criteria of drug-target engagement, dosage, and safety, and supports its intended clinical purpose.
A fit-for-purpose assay should be accurate, precise, selective, and sensitive in the detection of an analyte. Moreover, the assay should deliver high-quality results even in the presence of interfering matrix substances. To speed up assay method development and validation, a lower minimum required dilution with a broad bioanalytical range will help accelerate performance and save assay time.
Delivering reliable assay development and validation
For reliable assay validation, the use of high-performance antibodies is crucial in the capture and detection of an analyte. Such high performing antibodies can bound a unique epitope with high selectivity and generating stable immune complexes for sensitive detection of the analyte of interest. Ideally, for assay development and validation, a pre-quality controlled antibody reagent kit is preferred.
A simplified workflow with as less as possible manual operations can further reduce protocol errors and accelerate assay development timelines. Historically, immunoassays are performed in duplicates. With improved assay reagents and an increase in automation, singlicate analysis is now becoming routine procedures in automated bioanalytical testing. With a growing number of published studies supporting the use of singlicate analysis in ligand-binding assays, there is a clear paradigm shift in the acceptance and use of singlicate assays in regulatory submissions.
The simplest way to accelerate assay method development and validation is to employ ready-to-use assay kits that are already validated, verified, and undergone rigorous quality controls. Another way is to opt for a robust immunoassay that is complemented with a detailed description avoiding the need for assay method development. If such measures are not feasible or available, choosing the right assay platform based on a few selected variables can minimize assay errors and enable rapid method development.
The FDA recommends that assay development and validation laboratories should emphasize the determination of method validation needed unless biomarker info is planned to aid label claims. After assay development and validation, a high throughput platform speeds up the turnaround time and provides a window for other tasks like data analysis. Besides, high-throughput platforms capable of running simultaneous assays enable all data generation in a single run.
The future of assay development and method validation
Ultimately, the right assay platform is a vital step for speeding up assay method development and validation. Using high-performance immunoassays complemented with automated workflows will enable reliable data delivery and facilitate a smooth transition of development and manufacturing of drug products.
