Featured Articles

  1. Navigating The Regulatory Landscape Of mRNA-Based Therapeutics 7/21/2025

    Explore the evolving regulatory landscape of mRNA therapeutics in the EU and US, as well as learn key distinctions and strategic opportunities to optimize your mRNA drug development pipeline.

  2. Practical Applications For Controlled And Safe Nucleic Acid Delivery 7/21/2025

    Explore the science behind LNP formulation development, from ionizable lipids to scalable manufacturing through case studies, screening strategies, and flexible approaches for advancing next-generation therapeutics.

  3. Closed Sampling: Crucial For Aseptic Processing 6/26/2025

    Explore the critical role of closed sampling in bioprocessing by gaining insight into regulatory frameworks, system integrity, and aseptic practices essential to ensure compliance and product quality.

  4. Navigating The Complex Landscape Of Lentiviral Vector Quality Control 6/26/2025

    Explore the latest in lentiviral vector release testing, which covers biosafety, regulatory insights, and QC strategies to ensure patient safety and accelerate your path to clinic.

  5. Accelerate Your AAV Journey To IND And Beyond 6/26/2025

    Explore essential QC strategies in AAV gene therapy and learn how to address rcAAV detection, viral clearance per ICH Q5A, and impurity profiling using NGS to meet evolving regulatory demands.

  6. Real-Time Monitoring Of Solvent Clearance By TFF In The ADC Process 6/13/2025

    Raman spectroscopy revolutionizes ADC manufacturing by enabling real-time monitoring of solvent clearance. Discover how it enhances process control, ensures regulatory compliance, and supports the production of high-quality therapeutics.

  7. Using Next Generation Sequencing To Test Raw Materials 5/13/2025

    Explore the use of Next Generation Sequencing (NGS) to proactively screen raw materials in biopharmaceutical manufacturing, which aims to reduce viral contamination risks from animal-derived reagents.

  8. Replacement Of Traditional Adventitious Virus Testing 5/13/2025

    Explore how molecular-based technologies, including PCR and Next Generation Sequencing, are transforming viral safety testing by offering broader, more effective alternatives to traditional animal-based methods like in vivo assays.

  9. Handling Protocols: Key Considerations In The Highly Potent API Market 5/12/2025

    Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

  10. Little Patients, Big Challenges: Developing Pediatric Formulations 5/12/2025

    Explore the development of high-quality, child-friendly oral formulations, as well as learn about new testing requirements for impurities and innovative approaches to creating age-appropriate medications.