A single molecular descriptor to predict solution behavior of therapeutic antibodies.

Despite the therapeutic success of monoclonal antibodies (mAbs), early identification of developable mAb drug candidates with optimal manufacturability, stability, and delivery attributes remains elusive. Poor solution behavior, which manifests as high solution viscosity or opalescence, profoundly affects the developability of mAb drugs. Using a diverse dataset of 59 mAbs, including 43 approved products, and an array of molecular descriptors spanning colloidal, conformational, charge-based, hydrodynamic, and hydrophobic properties, we show that poor solution behavior is prevalent (>30%) in mAbs and is singularly predicted (>90%) by the diffusion interaction parameter ( ), a dilute-solution measure of colloidal self-interaction.

Characterization of NIR interfaces for the feeding and in-line monitoring of a continuous granulation process.

This work describes the characterization of three NIR interfaces intended to monitor a continuous granulation process. Two interfaces (i.e.

Development of an In-Line Near-Infrared Method for Blend Content Uniformity Assessment in a Tablet Feed Frame.

Process analytical technology (PAT) has shown great potential for in-line tableting process monitoring. The study focuses on the development and validation of an in-line near-infrared (NIR) spectroscopic method for the determination of content uniformity of blends in a tablet feed frame. An in-line NIR method was developed after careful evaluation of the impact of potential experimental factors on the robustness and model accuracy and precision.

Method Development and Validation of an Inline Process Analytical Technology Method for Blend Monitoring in the Tablet Feed Frame Using Raman Spectroscopy.

Inline process analytical technology sensors are the key elements to enable continuous manufacturing. They facilitate real-time monitoring of critical quality attributes of both intermediate materials and finished products. The aim of this study was to demonstrate method development and validation for inline and offline calibration strategies to determine the blend content during tablet compression via Raman spectroscopy.

Component detection weighted index of analogy: similarity recognition on liquid chromatographic mass spectral data for the characterization of route/process specific impurities in pharmaceutical tablets.

Detection and identification of impurities in pharmaceuticals is an essential task for determining the possible infringement of a patent. This article reports a multivariate analysis method to distinguish between tablets of the same substance on the basis of their origin, by characterizing route/process specific impurities via diagnostic ion chromatograms, using liquid chromatography/mass spectrometry (LC/MS). The approach is based on the formulation of a novel index that quantifies the similarity between LC/MS samples, named the component detection weighted index of analogy.