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 […]
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 […]
Presented by: Cindy Duhigg, Global Validation Steward, Alcon• Application of QbD for cleaning validation• Recognition that acceptance criteria are NOT goals• Determining what qualifies as a “toxicological evaluation”?• Discerning order from the chaos of all the health-based acronymsTakeaway Tools• Case study: Establishing formal health-based exposure limits
Presented by: David Vincent, Ph.D, Chief Scientific Officer, VTI Life Sciences• Current regulatory expectations• Life cycle approach to cleaning validation (FDA 3 stage approach)• How to gain cleaning process understanding by utilizing risk based approach• CIP and automated systems design and qualification of equipmento equipment selection clean by designo sprayball coverage studieso washout curveo holdup […]
Presented by: Anthony Grilli, CEO and Owner, FOCUS LaboratoriesSampling air and surfaces with agar plates for colony forming units in a manufacturing plant to assess effectiveness of contamination controls measures a blunt, labor intensive tool providing data a week or more after sampling. Shortages of media from suppliers due to Covid or natural disasters exacerbate […]
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