ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Design Verification Testing Of Combination Products

  Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.

• Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing

  Lonza’s SimpliFiH^®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.

• The Largest LOE Event In US Pharma History

  Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.

• Elastomer Plungers With Barrier Film For COVID-19 Vaccines

  Minimize the risks of accelerated drug development processes and the potential use of new vaccine platform technologies with the use of an elastomer plunger laminated with FluroTec™ barrier film.

• The Challenges And Opportunities Of Real-World Evidence: Part I

  Explore how the FDA's Real-World Evidence framework helps integrate real-world data into drug approval, improving efficiency, while ensuring data reliability and regulatory compliance.

• Developmental Testing Of IV Solutions

  As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

• Benefits Of Microparticle Technology For Oral Drug Solubility Enhancement

  Spray-dried dispersions, hot-melt extrusion, and solubilizing excipients are common solubility enhancement techniques, but new developments to maximize amorphous solid dispersion benefits are needed.

• Reformulation Of A Complex, High-Drug-Load, Modified Release Dosage Form

  What if you could limit and position a formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance?

• Developing And Manufacturing Drugs With HPAPIs

  Learn why companies must invest in specialized expertise to develop scalable, safe, and efficient manufacturing processes for highly potent oral solid dose products.

• Switching From Vials To PFS And Intravenous To Subcutaneous Formulations

  Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.