Overcoming Manufacturing Challenges for Accelerated Development

Paperless manufacturing is a big step for pharma companies. Manufacturers are continuously looking for innovative ways to accelerate new and existing plants and processes.

Sequence variants (SVs) are protein isoforms that contain one or more unintended amino acid substitutions. They can arise at a single amino acid site due to a genetic (RNA/DNA) mutation or at multiple amino acid locations, potentially due to translational errors, also referred to as misincorporations. The ability to detect SVs in protein biotherapeutics is critical due to their potential impact on structural/functional characteristics, safety, and efficacy. Trypsin peptide mapping with liquid chromatography-ultrahigh resolution tandem mass spectrometry (LC-MS/MS) provides the ideal workflow for the detection, identification, and relative quantitation of both genetic and translational SVs.

This webcast will describe the use of Raman spectroscopy techniques for improving the speed and efficiency of pharmaceutical testing. In the first of two presentations, transmission Raman is discussed as an alternative, non-destructive method for product release testing, working alongside HPLC to significantly reduce the costs and resources spent per content uniformity test. The second presentation focuses on the use of spatially offset Raman spectroscopy (SORS) for raw material testing through sealed opaque containers. Through-container testing removes the need for sampling—improving quality via increased or 100% ID testing, but with no additional resources required.

The boom of virtual and augmented reality in the healthcare and pharmaceutical industries is a major growth area for XR. However, there are still many regulatory challenges to overcome, and there are plenty of questions still to be answered.