Insights On Drug Development

  1. Get $mart: 1 Year Out From Phase 1 Injectable Trials, Avoid 3 Expensive Mistakes 3/6/2025

    Learn how to scale up injectable drug production for Phase 1 trials, avoid costly mistakes, and find the right CDMO partner for long-term success.

  2. CGMP-Validated RCL Assay Used For Release Testing Of Manufactured Viruses, Gene Mediated Cell Therapy Products 3/5/2025

    Ensure the safety and efficacy of lentiviral-based therapies by addressing the risks of replication-competent lentiviruses (RCLs) through advanced monitoring and control strategies.

  3. Achieving Rapid, High-Titer Expression For Next-Generation Biologics 3/5/2025

    This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

  4. Sequencing Solutions For Nucleic Acids And Advanced Therapy Products 3/5/2025

    Leveraging an experienced partner's expertise in GMP-grade plasmid manufacturing and advanced analytical methods can accelerate the development and success of your next-generation therapies.

  5. Discovery Through Commercialization: A Biologic Drug's Analytical Journey 3/4/2025

    Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

  6. Transforming A Liquid Protein Solution Into A Solid Oral Dosage Form 3/4/2025

    Unlocking the potential of oral protein therapeutics requires innovative formulation and manufacturing strategies to overcome stability, absorption, and bioavailability challenges.

  7. Molecular Properties Of PROTACs And The Relationship To Formulation Design 3/4/2025

    Here, we conduct a comprehensive analysis of diverse PROTAC (Proteolysis Targeting Chimeras) structures, evaluating their calculated physicochemical properties to identify key trends.

  8. Aseptic Processing Or Terminal Sterilization ― What's More Suitable? 3/4/2025

    Regulatory agencies prefer terminal sterilization over aseptic manufacturing, but is it suitable for your product? Industry manufacturing experts guide you in the selection and final delivery.

  9. The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly 3/3/2025

    In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

  10. Protect Patients, Ensure Regulatory Compliance With Impurity Control 2/28/2025

    A sponsor’s commitment to rigorous impurity control throughout manufacturing is vital to ensuring continuous patient safety. E&Ls, nitrosamines, and PFAS are among the most critical impurities to test for.