ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Complexing RNPs: Have You Established Your Clinical Acceptance Criteria?

  When using CRISPR-Cas proteins for gene editing, it’s critical to ensure consistency and quality at each stage of the manufacturing process. The FDA recommends establishing well-defined acceptance criteria for the RNP formation step.

• Laminar And Turbulent Mixing Techniques For LNP Formulations Scale Up

  Explore the critical factors in scaling up lipid nanoparticle (LNP) formulation, comparing the advantages and limitations of both laminar (microfluidic) and turbulent (tee and jet) mixing technologies.

• Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation

  In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.

• Writing Effective Clinical Regulatory Documents For Therapy Trials

  Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.

• Addressing Challenges In mRNA Drug Development And Manufacturing

  mRNA-based drug products serve as an ideal platform for use in infectious disease, protein replacement, and immuno-oncology applications due to the simplicity of manufacturing and robust immune response.

• Collaboration An Untapped Fuel For Driving Biopharma R&D

  Biopharma’s future depends on collaboration. Discover how cross-industry partnerships and shared resources can accelerate innovation, overcome talent gaps, and strengthen the global R&D ecosystem.

• Improving Toxicology Testing For Inhalation Products

  By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.