Maintenance / Service

WHITE PAPERS AND CASE STUDIES

• Enabling Quality By Design

  Outdated quality systems delay product release. Discover how manufacturers can harness real-time data, operationalize QbD, and enhance compliance, efficiency, and supply chain continuity.

• Injection Site Reaction Screening Methodology

  Optimize drug formulations for solubility at physiological pH to reduce injection site reactions, enable high-concentration dosing, and enhance patient comfort and compliance.

• Rescuing Data Integrity: A Swift Transition And Quality Transformation

  Uncover how this collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.

• 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.

• Forget About Isolators: Switching From Manual Vial To Automated Bag Filling

  Discover how transitioning from manual vial filling to single-use bag systems can reduce contamination risk, improve accuracy, and enhance GMP compliance in biopharmaceutical manufacturing.

• A Guide For Quality Professionals In Healthcare And Life Sciences

  Discover a guide for quality professionals that highlights essential principles and strategies for maintaining data accuracy, compliance, and innovation to ensure high-quality data in healthcare and life sciences.

• Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap

  As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

• Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars

  The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

• Orthogonal Methods To Understand And Define CQAs Of AAV Therapies

  An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.

• Retention Improved In A Pompe Disease Clinical Trial

  Explore the ways one double-blind, randomized Phase 3 study was able to boost the participant’s overall adherence to the protocol and increase their willingness to continue with the trial.

• Understanding Real-World Patient Characterization And Safety Outcomes Of DEXTENZA

  In this study, we can derive confirmation of DEXTENZA’s favorable safety profile across a broader surgical spectrum.

• Seamlessly Integrating An E-WorkBook With A Customer's LIMS

  Explore the story of a global biopharma company's integration of E-WorkBook with their LIMS, automating ADA study reports, saving significant time, and enhancing data accuracy.