Digitally Transforming Pharmaceutical Process Development and Manufacturing

Dramatic responses observed with targeted agents in the ‘right’ genomic context have fueled large scale sequencing efforts to identify ‘effective’ treatments for a given patient. In order to expeditiously evaluate a targeted agent against a potential ‘driver’ genetic aberration, so-called Basket trials are conducted.

The webinar will focus on the relationship between analytics of biotherapeutic products and the interpretation of data to build and support a solid regulatory Chemistry, Manufacturing and Control (CMC) strategy. The importance of data interpretation is illustrated in the development of biosimilars and new biological entities, as well as in regulatory specifications regarding biotherapeutic products.

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.

Explore the area of neuromodulation, which is seeing significant growth at a time when other medical device markets are facing declining growth. The team focus on three targeted neuromodulation areas, including: spinal cord stimulation (SCS), deep brain stimulation (DBS) and vagus nerve stimulation (VNS).