ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Factors To Consider When Selecting A CDMO For Complex Injectables Development And Manufacture

  The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities and operations to adopt GMP practices with a "laboratory setting."

• The Path To Commercialization For Wearable Drug Delivery Devices

  Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.

• Advancing A LNP Formulation To Clinical And Commercial Manufacturing

  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.

• Maximize Global Regulatory Collaboration

  When marketing a combination product globally, pharmaceutical manufacturers and drug delivery technology providers must have a collaborative infrastructure based on strategic alignment, proactive regulatory awareness, lifecycle support, and continuous improvement globally.

• Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics

  All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

• Prioritize Safety And Mitigate Risk In HPAPI Manufacturing

  As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.

• Pediatric Dosage Form Development: Program Design And Formulation Development

  Explore key considerations to successfully bridge from initial concept of pediatric program design and formulation development strategies into later stages of development and through to commercialization.

• White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges

  Explore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.

• Sterile Injectable Therapies: Revolutionizing Lifecycle Management

  The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.

• How Lipid Nanoparticles Overcome Solubility Challenges

  More than 80% of NCEs are poorly soluble compounds. Overcoming this challenge using lipid nanoparticles is essential to move your drug product through the pipeline and into the market.