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  1. The Cost Of Delaying Digital Validation 9/9/2025

    Digital validation is reshaping quality assurance to offer speed, scalability, and strategic advantage. Discover how digital tools can elevate your QA approach.

  2. Development Of A Non-Standard Protein Therapeutic 9/9/2025

    Discover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.

  3. The New FDA Era Of Radical Transparency And Pervasive Oversight 9/9/2025

    The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.

  4. Innovation At Your Fingertips 9/8/2025

    Variability in cell culture media can impact product quality. Explore how CCM Fingerprinting quantifies key components in a single assay to help streamline release testing and media development.

  5. A Case Study In Continuous Process Verification 9/8/2025

    CPV can strengthen the bridge between compliance and continuous improvement. In this scenario, a hypothetical lab sets out to improve process yields and efficiency.

  6. Benefits Of Outsourcing To An Integrated CDMO 9/8/2025

    Streamlining ADC development through an integrated CDMO can reduce risk and improve quality. Discover why specialized expertise in linker chemistry and bioconjugation is key to overcoming the complexity of ADC manufacturing.

  7. A Cloud-Based Quality And Compliance Solution 9/8/2025

    Empower smarter decisions by combining trusted Salesforce integration and AI-enhanced quality management to drive efficiency, scalability, and continuous improvement across your organization.

  8. Enabling Quality By Design 9/8/2025

    Outdated quality systems delay product release.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

  9. Optimizing Lentiviral Vectors For Allogeneic CAR-T Manufacturing 9/5/2025

    A group of graduate researchers explored VSV-G affinity chromatography as an alternative to the standard anion exchange chromatography or AEX.

  10. Reliably Predicting Biologics Hotspots From Prior Knowledge 9/5/2025

    Site-specific post translational modifications can seriously affect a molecules stability, function, and structure. These modifications are commonly called "hotspots."