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

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. […]

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Medical Product Excursions from Labeled Storage Conditions

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 […]

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Cleaning Validation Demystified: A Comprehensive Guide and Case Studies

Presented by: John Wrenn, Country Manager, Australia & New Zealand , CAI Cleaning validation can be a confusing topic for many people as there can seem to be conflicting information and guidance. This webinar will give you a broad overview of cleaning validation and describe the history and fundamentals of cleaning validation and how we […]

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Navigating the Path of Annex 1 Compliance: A Journey towards Regulatory Adherence and Batch Release

Presented by: Connie Leech, Global Director Quality, Compliance & Regulatory Affairs , CAI Top Reasons to watch Comprehensive Overview: Get a comprehensive overview of Annex 1 and its role in ensuring the sterility and quality of medicinal products, empowering you with essential knowledge for your role in the industry. Expert Insights: Gain valuable insights from […]

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Digital Cleaning Validation Lifecycle

Presented by: Rui Almeida, Director, Product Life Cycle Management Services, ValGenesis. Inc. Cleaning validation is a complex process. Over the years, the industry has moved on with a structured risk based lifecycle approach following FDA Process Validation Lifecycle principal guidance. Using old processes, it remains a challenge to eliminate human errors. This presentation shows how […]

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  • Email: info@kenx.org
  • Phone: 858 649 3251
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