ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Viral Vector Based Gene Therapy Drug Products: The Right Primary Container

  Explore the major considerations for an ideal primary container for viral vector-based gene therapy drug products and the existing and new solutions in this space.

• Streamlining The Path To Market For Generic Drug-Device Combinations

  Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.

• Considerations In Development & Manufacturing Of Complex Injectables For Early Phase Studies

  A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.

• Microphysiological Systems: Closing The Gap Between Models And Medicine

  Microphysiological systems (MPS) use human cells to model tissue function, offering faster, more predictive insights for drug discovery, safety testing, and personalized medicine—bridging gaps left by animal and 2D models.

• Reducing Lead Time & Optimizing Costs

  Explore how the use of this component platform produces significant savings, reduces elastomer SKU complexity, and increases speed to market.

• Streamlining Primary Container And Device Selection With Predictive Calculations

  Expolore a theoretical approach to complement experimental approaches to more quickly select a packaging and delivery system for your drug product.

• Combining Gene Therapies, Carrier Systems, And Medical Devices

  Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies.

• Fixtures And Surrogates For Combination Product Performance Testing

  The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.

• Navigating Regulatory Challenges In Oligonucleotide Therapeutics

  Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.