Using Real-World Evidence for U.S. Regulatory Decision-Making: What Pharma Needs to Know

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.

At Natoli Scientific, we’re in the lab every day compiling thorough USP Tablet Compression Characterization data to help you identify and solve compaction problems and provide solutions.

Cryo-electron microscopy (cryoEM) is a Nobel Prize-winning technique for solving high-resolution three-dimensional structures of biological molecules such as proteins, that is used for structure-based drug design. Key to the success of cryoEM are significant advances in high performance computer vision and machine learning algorithms, used to extract information from large numbers of noisy 2D microscope images and compute and refine 3D structures of target proteins in near-native states.

Developing and bringing a new drug to market is a long, expensive, and uncertain process. It’s even more complicated when it comes to complex products such as modified-release products and biologics. Bio/pharma companies can adopt proven strategies to increase the success of a product launch: cross-functional team collaboration, risk understanding and mitigation, a dedicated team, and the right project management tools. In this webcast, experts will share insights gained from decades of experience launching new products and discuss case studies demonstrating how to reliably bring products to market quickly without sacrificing compliance.