Critical quality attributes (CQA) are fundamental to regulatory compliance and in drug development and manufacturing. Find out how surface plasmon resonance has been applied for protein characterization of antibody effector function.
Critical quality attributes (CQA) are fundamental to regulatory compliance and typically include data on how the candidate interacts with target proteins, size, and purity. In addition, information on process related CQA such as protein integrity, homogeneity, presence of host cell proteins, and DNA is required. This poster booklet provides a snapshot on how different analytical technologies have been used to look into aspects related to the efficacy, stability, and safety of therapeutic candidates.
Evaluating how much a process step contributes to viral clearance is an essential part of process validation in order to be sure you are manufacturing safe drugs. Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.
Equipment qualification seems like a straightforward process. However, things usually go awry when gathering a validation team and defining and documenting the intended use and system requirements.
For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”
Most in the life sciences agree that artificial intelligence (AI) will reshape the sector from R&D through commercial. Although AI has only just left the starting gate, and most activity is in exploratory phases, some benefits are starting to emerge. And there are pockets of early adopters trailblazing new approaches and seeking a competitive edge.
Dassault Systemes offers the SIMULIA Living Heart Human Model designed as a high-fidelity Multiphysics model of a healthy, 4-chamber adult human heart and proximal vasculature. The model features a dynamic response governed by realistic electrical, structural, and fluid (blood) flow physics. With this heart model, medical professionals, researchers, and device manufacturers have the ability to conduct experiments in a highly realistic 3D environment.
The EMA and the FDA reported a major issue regarding the detection of a genotoxic impurity, NDMA (N-nitrosodimethylamine), and subsequently NDEA (N-nitrosodiethylamine), in lots of valsartan, an API used to manufacture generic angiotensin receptor blockers. The API at issue was supplied by two Chinese companies and was later discovered in API manufactured by an Indian manufacturer.
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