Featured Articles

  1. 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.

  2. Overcoming Obstacles On The Journey To Commercialization 5/28/2024

    Explore case studies in the development and manufacturing of APIs and HPAPIs as well as innovative solutions designed to address and overcome challenges in bringing new medicines to patients.

  3. Strategic CMC Planning Through A Phase-Appropriate Quality Approach 5/28/2024

    A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development phase. Watch how to apply such an approach to CMC planning.

  4. Pressure Testing Your Readiness To Ensure GMP Batch #1 Success 5/28/2024

    Watch as an expert from an industry-leading CDMO provides insights into the crucial factors, challenges, and tech transfer methods needed to achieve right-first-time readiness and success.

  5. Key Quality Attributes For mRNA Drug Substance Performance 5/23/2024

    Explore the evolution of the mRNA-based therapeutics pipeline, and gain insights into the key quality attributes and associated analytics that influence mRNA performance, including best practices.

  6. How To Bring Your LNP Formulation To Clinical/Commercial Manufacturing 5/23/2024

    Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.

  7. An Early Formulation Screening Service 5/23/2024

    Gain insights into overcoming the challenges in lipid nanoparticle (LNP) formulation, explore critical aspects of the process and analytical development of LNPs, and much more.

  8. 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.

  9. Accelerating The mAb Formulation Process 5/7/2024

    Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.

  10. 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.