2006: A Regulatory Odyssey
The regulatory environment is changing and is starting to sweep away some of the commandments on which we have relied, and to change others almost unrecognizably. To make the transition, FDA will have to reinvent itself and industry will have to rethink the way we develop and manage our processes.
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.
Inside the Laboratory: The Richardson Group at the University of South Carolina
November 20th 2024In this edition of “Inside the Laboratory,” Susan Richardson of the University of South Carolina discusses her laboratory’s work with using electron ionization and chemical ionization with gas chromatography–mass spectrometry (GC–MS) to detect DBPs in complex environmental matrices, and how her work advances environmental analysis.
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.
Infographic: Be confidently audit ready, at any time and reduce failures in pharma QC testing
November 20th 2024Discover how you can simplify the audit preparation process with data integrity dashboards that provide transparency to key actions, and seamlessly track long-term trends and patterns, helping to prevent system suitability failures before they occur with waters_connect Data Intelligence software.
Critical Role of Oligonucleotides in Drug Development Highlighted at EAS Session
November 19th 2024A Monday session at the Eastern Analytical Symposium, sponsored by the Chinese American Chromatography Association, explored key challenges and solutions for achieving more sensitive oligonucleotide analysis.
