Insights On Quality Assurance

  1. A Guide To The Ultimate Product Improvement Tool 2/18/2025

    Learn how to transform your product quality review that emphasizes systematic evaluation and improvement of product quality, highlighting automation benefits through modern software.

  2. A State-Of-The-Art Syringe Liquid Sampler 6/24/2025

    Discover a cutting-edge syringe liquid sampler for Life Sciences that offers USP <788> compliance, versatile syringe compatibility, and advanced features for precise particulate testing.

  3. ICH Q2 And ICH Q14 Revisions Clarify Analytical Methods For Biologics 8/30/2024

    Learn about the revisions to ICH Q2 and Q14 that provide clarification on analytical methods for biologics, aiming to ensure accuracy, reliability, and consistency in testing these products.

  4. Innovative Strategies For Residual DNA And Viral Titre Quantitation 5/22/2025

    Discover how digital PCR improves the accuracy of residual host cell DNA and viral titre quantification in biotherapeutic manufacturing to enhance product quality, safety, and regulatory compliance.

  5. A Shift Towards Biofluorescent Particle Counters In Manufacturing 5/12/2025

    Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.

  6. Biopharmaceutical Manufacturing Conference: Embracing Technology And Innovation 11/6/2024

    Industry leaders gathered at the PDA Ireland Chapter event to discuss how innovation and technology are transforming biopharmaceutical manufacturing, addressing challenges, and driving efficiency.

  7. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  8. How Robotic Isolator Technology Aligns To Annex 1 Principles 4/28/2025

    Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.

  9. Rethinking Sustainability In Bioprocessing 5/22/2025

    Discover how sustainability is transforming bioprocessing through innovative single-use technologies that help reduce environmental impact and support responsible, forward-thinking biomanufacturing.

  10. EAD-Based Middle-Down Workflow Analysis 9/21/2023

    How can a single-injection, EAD-based middle-down workflow leverage accurate mass measurement, information-rich EAD fragmentation and automated data analysis to offer confident sequence confirmation.