Created by: Fred Ohsiek, Cleaning Validation Expert Developing 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 developing the automated CIP process for a new facility, […]
Created by: Jennifer Spiegler, Staff Validation Engineer at Janssen Biologics Leiden, the Netherlands In 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 orphan drug products since the chromatography columns are dedicated per product. […]
Created by: John O’Neill, Facilitator, PSDG, Editor, StabilityHub.com Stability 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 […]
Created by: Christopher V. Latoz, Stability Manager, Hollister Incorporated Many laboratories have not taken the time to develop a disaster plan, or the plan they have created has not been reviewed or revised for several years. In this article, we’ll discuss key elements that should be incorporated in a laboratory disaster plan, including a hazard […]
Authors: Valerie Mulholland, Pharmaceutical Regulatory Science Team (PRST), Technological University DublinProfessor Anne Greene, Director PRST, Technological University Dublin The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST has […]
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