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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 […]
Created by: Fred Ohsiek, Senior Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North AmericaDeveloping an automated clean-in-place (CIP) recipe is a challenging activity for project such as a new facility, equipment or wing addition to an existing facility, a new product, or optimizing a legacy cleaning process. This article will focus on […]
