ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Patient Adherence With A Novel Dosage Form

  A sprinkle formulation helps patients with tremors or dysphagia take medication more easily, improving adherence, comfort, and care through a novel, FDA-approved oral granule format.

• Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls

  Utilizing off-the-shelf (OTS) devices for drug delivery can offer significant advantages to development programs in timeline and risk mitigation. Understand the design control responsibilities of a sponsor when using OTS devices.

• Contract Design And Development Vs. In-House: Finding The Best Fit

  Outsourcing medical device R&D to Contract Development Organizations (CDOs) aids innovation, scales resources, and overcomes constraints. Strategic evaluation ensures successful partnerships.

• Lyophilized Products Are On The Rise: What You Need To Know

  There is increased demand for lyophilization services in the manufacturing of new biologic drugs and injectable formulations as well as in change of formulation presentation.

• 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.

• 4031 Ready Methods Reduce E&L Timelines

  An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.

• High Potent Formulation Development In Oncology

  Examine the vital role formulation development plays in oncology outsourcing and how sponsors can increase their chances of success with the right CDMO partner.

• Liposome Vs. Lipid Nanoparticle: What's The Difference?

  Here, we discuss the differences between nanoparticles and liposomes along with their applications in medicine.

• Less Mess, Less Stress, Best Expressed: An Alternative To Spray Drying

  Although well-established processes, spray drying and hot-melt extrusion can be outperformed in bioavailability, cost-savings, manufacturing speed, environmental impact, and more.

• 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.