Created by: Jacob Hodovsky, Computer Systems Validation and Project Manager, CAIDay-3-1045am_Jacob-Hodovsky_DI-Maturity-Factor-Assessment-Workshop-HandoutDownload To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.
Created by: Jacob Hodovsky, Computer Systems Validation and Project Manager, CAIDay-3-1045am_Jacob-Hodovsky_DI-Assessment-Tool-Workshop-HandoutDownload
Created by: Mehron Mirian, Director of Automation Services, VTI Life Sciences Day-2-415pm_Mehron-Mirian_-Handout-GAMP5checklistR0-3Download
Created by: Jennifer Spiegler, Staff Validation Engineer at Janssen Biologics Leiden, the NetherlandsIn traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphandrug products since the chromatography columns are dedicated per product. In this […]
Created by: John O’Neill, Editor, StabilityHub.comStability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of product during […]
