Featured Articles

  1. BioPhorum Raw Materials Risk Assessments 12/19/2024

    Torsten Schaderdorf provides an in-depth exploration of current regulations related to Raw Materials Risk Assessment, highlighting the risk criteria and raw material scope outlined in the BioPhorum guidelines.

  2. Assemblies Are Not Particulate Free, Strategies For Risk Mitigation 12/19/2024

    As single-use technologies gain prominence in critical applications, the scrutiny around particulate contamination intensifies due to its potential impact on drug product quality, safety, and patient outcomes.

  3. Transforming The Biopharma Supply Chain, eData Solutions For Agility And Manufacturing Efficiency 12/19/2024

    Explore the role of eData in automating processes, enabling predictive analytics, improving supply chain resilience, and adopting standardized digital platforms in biopharma manufacturing.

  4. Managing Nitrite Impurities: Supplier-Manufacturer View 12/19/2024

    Examine nitrites in excipients, nitrosamine risks, regulatory considerations, analytical controls, and a case study on mitigating risks in pharmaceutical manufacturing and storage.

  5. How Standardized Extractables Data Support E&L Risk Assessment 12/19/2024

    Explore E&L evaluations, USP <665>, supplier-provided extractables data, and collaborative strategies to mitigate risks in Single-Use Systems for biopharmaceutical manufacturing processes.

  6. Evaluating USP 665 For Extractables Testing And Reducing Animal Testing For Biological Reactivity 12/19/2024

    Explore evolving compendial methods, USP <665>, and transitioning to cell-based assays for extractables, leachables, and biological reactivity in single-use pharmaceutical manufacturing.

  7. Challenges Using Multiple Single-Use Systems Functionality Versus Extractables And Leachables 12/19/2024

    Explore a risk assessment of extractables, evaluating single-use components, and addressing complexities in manufacturing processes, with a case study highlighting compatibility and patient safety concerns.

  8. If You Can't Win The Game, Change It 12/11/2024

    Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.

  9. mRNA Purification Using Anion Exchange Chromatography At Ambient Temperature 12/11/2024

    Explore how anion exchange chromatography with dual gradient elution enables efficient mRNA purification at ambient temperature.

  10. Data Integrity In The Quality Control Lab: No Pen, No Pain 12/10/2024

    Data integrity in pharmaceutical QC labs is critical for product safety. This webinar explores digital solutions to improve traceability, reduce paperwork, and enhance workflows.