Insights On Quality Assurance

  1. 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.

  2. CE-SDS Analysis Of Etanercept Using The BioPhase 8800 System 9/21/2023

    In this study, a system with multi-capillary capabilities was used to analyze etanercept by bapillary electrophoresis-sodium dodecyl sulfate (CE-SDS).

  3. Best Practices In The Design Of A Pharmaceutical Manufacturing Facility 11/6/2024

    A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.

  4. Navigating The FDA's Drug Supply Chain Security Act 3/14/2025

    Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.

  5. Digitalizing Biopharma Manufacturing Step-By-Step: Part II 11/1/2023

    Explore a modular approach to digitalization involving the development of electronic logbooks and procedural guides, weigh and dispense processes, and Master Batch Records/Electronic Batch Records.

  6. Navigating The Nuances Of Process And Analytical Development 5/15/2024

    This panel discussion explores the intricate challenges in transitioning cell therapy processes from research to Good Manufacturing Practice compliance.

  7. Vaccine Journey: Bench To Market 7/19/2023

    Vaccines are entering a new era. Gain insight into the market trends, projections, challenges, and potential solutions around the future of vaccine manufacturing.

  8. Are You Aligned With FDA's Computer Software Assurance Methodology? 3/19/2025

    Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.

  9. Optimizing Process Loads For VHP Decontamination 2/20/2024

    Explore how CAI helped a company rescue a failing CQV project and create more efficient Vaporized Hydrogen Peroxide Material Air Lock (VHP MAL) Loads to enhance operational efficiency.

  10. Enhance Peptide Innovation With A High-Quality Supply Of Building Blocks 1/29/2025

    To leverage the benefits of peptide therapeutics, identify an experienced chemical material manufacturer that can produce unique peptide building blocks with quality, efficiency, and continuous compliance.