How to Validate a GPC/SEC System
Validation is not an easy task. It is an ongoing complex process that evaluates the entire, sample specific process, products and analytical methods.
Validation is not an easy task. It is an ongoing complex process that evaluates the entire, sample specific process, products and analytical methods and consists of four qualification phases: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification/Performance Verification (OQ/PV) and Performance Qualification (PQ).
Before the first sample is analysed, users have to verify and document that the system meets the user requirement specifications, is correctly installed and working according to the manufacturer’s specifications in the selected environment.
Validation of the system is complete after the instrument hardware, software, data, analytical method and operators are factored in the process. In addition to simple performance tests for each isolated component, it is essential to confirm that the complete system works according to the performance specifications of the analysis method (holistic approach). Here it is important to take the specific requirements of the applied method into account. This ensures that all critical parameters influencing the results are identified and properly monitored over the system’s life cycle.
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.
2024 EAS Awardees Showcase Innovative Research in Analytical Science
November 20th 2024Scientists from the Massachusetts Institute of Technology, the University of Washington, and other leading institutions took the stage at the Eastern Analytical Symposium to accept awards and share insights into their research.
