ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing

  In this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk. 

• Formulation Development Strategy For Early Phase Human Studies

  Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.

• Why Connect An Auto-Injector To A Smartphone?

  Why would a person with diabetes want to link their auto-injector to the Internet? Given that smartphones are so central to our everyday lives, it could be argued that the better question is: Why not? 

• Addressing Regulatory Challenges For Ophthalmic Combination Products

  Classifying eye drops as combination products complicates approval. Learn how identifying the primary mode of action early and aligning dual quality frameworks prevents costly launch delays.

• Accelerate Development Of Enabled Formulations For Poorly Soluble Drugs

  Explore how a platform integrating drug substance, drug product, and clinical testing within a single organization accelerates development and reduces costs, helping deliver positive outcomes earlier.

• Have You Selected The Right Stopper For Your Lyophilized Drug Product?

  Component selection is a complex process. Packaging considerations should occur concurrent with drug development to mitigate risk at every step of the drug development process.

• Exploring Lipid Nanoparticles For Drug Delivery

  Using lipid nanoparticles (LNP) for drug delivery is a promising area of research. Discover the benefits of LNP delivery, the different types of lipid nanoparticles, their safety for drug delivery, and more.

• Solving The Silicone Challenge In Pre-Fillable Syringes

  Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

• Sample Sizes For Performance Testing Of Combination Products, Packaging

  When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

• Closing The Duration Gap In FDA-Approved Long-Acting Contraceptives

  A gap exists between three months and three years in FDA-approved long-acting contraceptives (LACs). A microsphere formulation enables sustained release over a six to twelve-month period.