Measuring bioburden in pharmaceutical water systems has almost exclusively depended on time-consuming, error-prone culture-based lab measurements. Developments in spectroscopic technology offer accurate, continuous, on-line determination of microbial contamination.

The objective of this research is to investigate the extrusion process space in co-rotating and counter-rotating extruders, which is critical in ensuring the properties of pharmaceutical solid dispersions.

Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing. Though small differences in-vitro dissolution are not expected to result in significant in-vivo performance differences, the slight in-vitro dissolution delay observed by over-encapsulation for double blind clinical trials, as well as switching from gelatin to HPMC capsules often raises concerns on the potential impact on in-vivo bioavailability.

This application note describes how to perform ADC peptide quantitation using an Accurate Mass Screening workflow and demonstrates the workflow capability of comparing key product attributes of ADCs across samples.