Featured Articles

  1. Integrated Approach In Managing CPV And APQR 11/12/2024

    Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.

  2. Regulatory Expertise And CMC Document Preparation To Support mRNA-Based Therapeutic Development 10/7/2024

    Explore the regulatory requirements for mRNA drug substances and products, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance.

  3. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

    Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

  4. Accelerating Bulk Harvest Release Testing With A PCR-Based Solution 7/3/2024

    Adventitious agent testing is frequently a bottleneck in downstream processing. Discover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.

  5. Optimizing mRNA For Success: A Guide To Enhanced Stability, Delivery, And Efficacy 6/11/2024

    RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.

  6. The Next Generation Of mRNA Products: Implications For Quality Control 5/30/2024

    To fully realize the potential of mRNA as a therapeutic or vaccine modality, developers will need to employ cutting-edge analytical methods to ensure the safety and efficacy of these novel products.

  7. Benefits Of PCR-Based mRNA Manufacturing Processes 5/17/2024

    Learn about a proprietary polymerase chain reaction (PCR) solution that was developed to overcome the challenges associated with pDNA that applies the high accuracy of PCR to mRNA manufacturing.

  8. De-Risk mRNA Regulatory Approvals 4/29/2024

    Gain insight into how you can de-risk mRNA regulatory approvals with critical quality attribute characterization and lot release testing.

  9. Formulation Process And Analytical Development Capabilities 3/25/2024

    Explore process and analytical development capabilities that can help you advance your formulation to GMP Manufacturing.

  10. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/25/2024

    Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.