ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Drug Formulation Development: Quick Reference Guide

  This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.

• De-Risking Visible Particles Through Component Selection

  Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

• A Technical Package That Serves On-Time Injectable Project Completion

  The accuracy, robustness, and completeness of the technical package an organization submits to its development and/or manufacturing partner is critical to meeting fill project timelines.

• Nose To Brain (N2B) Drug Delivery – Benefits And Challenges

  Delve into the growing interest in drug delivery methods that target the brain and central nervous system via absorption into the bloodstream, specifically focusing on crossing the blood-brain barrier (BBB).

• Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems

  Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.

• Sterile Injectable Therapies: Revolutionizing Lifecycle Management

  The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.

• Are Drugs Becoming More Lipophilic Over Time?

  Get a deeper look into how drug lipophilicity has evolved over time, its impact on drug development, and the need for new technology to enable new more complex drugs.

• 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.

• Which Testing Does An Effective Certificate Of Analysis Include?

  Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

• Responding To Trends In Prefilled Delivery: Component Assessment And Selection

  Existing plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.