Category: Article

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Improving Risk-Based Decision Effectiveness: Addressing Uncertainty

Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe 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 […]

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Cleaning Validation Program Design: Risk-Based Lifecycle Approach

Created by: Matthew Jackson, Validation Manager, Torbay PharmaceuticalsThis article was based on my session, Cleaning Validation Program Design: Risk-based Lifecycle Approach, delivered at the KENX’s Cleanroom Validation, Disinfection & Environmental Monitoring Conference April 27-29, 2022 Virtually and in person in Philadelphia, PA.KENX-Insight_Matthew-Jackson_Cleaning-Validation-Program-Design_August-2022-1Download

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CIP Cleaning Cycle Development Pitfalls and Solutions

Created by: Fred Ohsiek, Cleaning Validation ExpertDeveloping 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, but […]

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Innovative considerations for efficient multi-(product) use of Protein-A columns

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 orphan drug products since the chromatography columns are dedicated per product. In […]

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Medical Product Excursions from Labeled Storage Conditions

Created by: John O’Neill, Facilitator, PSDG, 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 […]

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