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WHITE PAPERS AND CASE STUDIES

• Membrane Adsorber Chromatography In Oligo-mAb Conjugation

  Discover how the team was able to expedite the conjugation of an oligonucleotide-monoclonal antibody (oligo-mAb) program leveraging experience in chromatography.

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• Evaluating Milling Conditions For Scaling Up A Nanosuspension Drug Product

  Aiming to obtain a target particle size to support Phase 3 clinical trials, uncover how this study contributed insights on nanosuspension drug product production at escalated scales.

• RO Membranes' Protection At SWRO Facility, Asia

  Atlantium HOD UV systems provide effective RO membrane protection by combining ultraviolet water disinfection technology with hydraulic and optic principles.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• OEE And Product Inspection

  Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.

• Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

  Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• Efficient Carbon And Ion Exchange Media Exchange

  This document outlines the essential steps required to exchange spent media, including disposal of spent media.

• Labware Washing Techniques And The Sinner's Circle

  Explore labware cleaning techniques, comparing manual and automated processes, and how balancing the four factors of the Sinner’s Circle ensures effective, repeatable laboratory outcomes.

• BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times

  Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.