A Quality by Design Approach to Chromatographic Method Development
An overview of a QbD process for chromatographic method development.
Quality by Design (QbD) has recently been advocated by the FDA and applied to the development and manufacture of drugs within the pharmaceutical sector. In efforts to ensure consistent quality and performance of drugs, ICH guidelines1 and recommendations encourage pharmaceutical companies to improve process control by adopting a QbD approach early in drug development.
Understanding how QbD applies to the development of chromatographic methods, as a process, requires a closer look into the architecture of method design, the influence of input variables on critical output measurements, and use of modern software tools to support QbD objectives. Practical implications of QbD include modelling the influence of variables on quality, design of experiments and refinement of processes as information is collected.
Identifying Antioxidative Properties in Berries with UHPLC-MS
Published: November 27th 2024 | Updated: November 27th 2024A recent study identified and quantified anthocyanin (which are known for their antioxidative properties and potential effectiveness against depression) in blueberries, blackberries, black mulberries, and cranberries using ultra high-pressure liquid chromatography (UHPLC) followed by in vivo evaluation of their antidepressant-like activities.
AI and GenAI Applications to Help Optimize Purification and Yield of Antibodies From Plasma
October 31st 2024Deriving antibodies from plasma products involves several steps, typically starting from the collection of plasma and ending with the purification of the desired antibodies. These are: plasma collection; plasma pooling; fractionation; antibody purification; concentration and formulation; quality control; and packaging and storage. This process results in a purified antibody product that can be used for therapeutic purposes, diagnostic tests, or research. Each step is critical to ensure the safety, efficacy, and quality of the final product. Applications of AI/GenAI in many of these steps can significantly help in the optimization of purification and yield of the desired antibodies. Some specific use-cases are: selecting and optimizing plasma units for optimized plasma pooling; GenAI solution for enterprise search on internal knowledge portal; analysing and optimizing production batch profitability, inventory, yields; monitoring production batch key performance indicators for outlier identification; monitoring production equipment to predict maintenance events; and reducing quality control laboratory testing turnaround time.
Innovative cryogen-free ambient air monitoring of trace-level air toxics at high humidity
November 27th 2024This application note presents an advanced analytical system for the sensitive detection of trace-level air toxics in humid ambient air samples, in accordance with US EPA Method TO-15A. The cryogen-free preconcentration and thermal desorption approach, coupled to GC-MS, delivers exceptional chromatographic performance even for highly volatile and polar compounds. The system meets the stringent detection limit requirements of the latest air monitoring regulations, with method detection limits as low as 0.7 pptv. This innovative analytical solution provides a robust, cost-effective platform for the reliable quantification of hazardous air pollutants, enabling compliance with regulatory standards.
Continuous, cryogen-free on-line monitoring of PAMS in ambient air using hydrogen carrier gas
November 27th 2024This application note explores an efficient, helium-free method for continuous monitoring of ozone precursors in ambient air, aligned with EPA PAMS requirements. By using hydrogen as the carrier gas, this approach achieves faster run times, stable retention times, and effective separation of volatile organic compounds. A case study from New York City highlights the system's performance in urban air quality monitoring, capturing shifts in pollutant levels during periods of reduced traffic. With remote operability and cryogen-free functionality, this method offers a reliable and sustainable solution for real-time air quality analysis in both urban and remote environments.
