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.

• Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization

  Biologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. As these therapies often require low annual volumes, the associated device manufacturing strategy must also fit commercial expectations, even at those volumes. 

• 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.

• Harness High-Quality PBPK Modeling To Enhance Clinical Readiness

  Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• Implementing Medium And High-Volume Drug Handling And Packaging Programs

  Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.

• How To Address Challenges In Oncology Drug Containment

  Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance. 

• Streamline Your Fill And Finish Process Of Ready-To-Use Cartridges

  An optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics to improve efficiency in pharmaceutical production.

• Overcoming A Failed Design Verification Test For Your Delivery Device

  If a drug delivery device fails a design verification test, the consequences can be lost revenue for the pharma company and delays for patients. Explore how to eliminate design verification failure.

• The Gateway Delivery To The Brain

  Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.