This whitepaper provides a summary of the impact of PIC/S, and compliance with the PIC/S document PE 009-12 “Guide to Good Manufacturing Practice for Medicinal Products Annexes“ Annex 11 Computerised Systems. It includes a high-level foundation to understand how pharmaceutical manufacturing companies are being regulated, what PIC/S means for common requirements across different countries, and how these requirements relate to expectations for data from computerised systems/electronic records.
Analyze Charge Variants in Antibody-Based Therapeutics Using Cation Exchange Chromatography
July 18th 2024This application note discusses the latest development on high performance cation exchange bio-separation columns for determining charge variants in protein-based biotherapeutics, as well as the strategy on method development.
The Power of HPLC/SFC Control and AQbD in One Software
July 17th 2024Download this infographic for a quick overview of Shimadzu’s LabSolutions Method Development (MD) software, an effective and automated software solution for U/HPLC method development that uses analytical quality by design (AQbD) principles in its workflow.