This field has evolved considerably through the integration of systematic design strategies, notably the incorporation of Analytical Quality by Design (AQbD) principles and robust statistical tools ...

Although the targets of biomanufacturing have evolved from therapeutic proteins to “advanced therapies” and now to gene therapies, the issues and solutions remain the same. The production of safe, ...

Bioassay variability can pose significant challenges due to laboratory conditions, instrumentation, analytical software, cell culture performance and reagent sourcing. These inconsistencies can impact ...

As cell therapies become more complex, the need for robust analytical tools to characterize such products as they enter the clinic has increased in kind, especially those related to flow cytometry.

When balanced data are analyzed by a robust method, different weights are applied to data points depending on their apparent status as outliers. This results in the effective unbalancing of the data.

1. Research that yields conflicting results rightly causes controversy. Where methodological weaknesses are apparent, there is ready opportunity for discord within the scientific community, which may ...

Analytical Quality by Design (AQbD) principles call for a deeper, more systematic understanding of all factors that influence the performance of analytical procedures in quality control. By embedding ...

Responding to a lack of sensitive analytical methods for detecting associated medications in complex wastewater matrices, researchers at the University of Louisville developed and validated a liquid ...

Techniques like SPME and QueChERS enhance sustainability by minimizing solvent and consumable use in sample preparation. With ...