ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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?

• Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination Products

  Learn how formulation, device, quality, and engineering teams can strengthen contamination-control strategies, improve delivery reliability, and reduce product-quality risk throughout the drug-delivery lifecycle.

• Low Temperature Storage Containment For Vial And Syringe Systems

  With the growth of advanced therapy medicinal products, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50°C to ≤ -130°C.

• Meeting The Growing Demand For Pre-Filled Syringes

  The market for pre-filled syringes is growing rapidly. Learn more about the benefits for consumers, providers, and manufacturers, and the importance of partnering with a reliable fill finish facility.

• The Growth Of Sterile Injectables

  Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.

• Four Special Fill/Finish Considerations For Vaccine Production

  Examine considerations regarding the handling and process for fill/finish to ensure the stability and purity of your vaccine as well as limit unnecessary waste and cost.

• An Easy-To-Swallow Depression Drug For Elderly Patients

  Examine how an innovative formulation approach helped a developer create a version of their drug that promotes treatment compliance within the geriatric population.

• Lyophilization Contract Manufacturing Services: What To Know

  Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.

• 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. 

• Understanding Of Amorphous Solid Dispersions & Their Downstream Development

  Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.