ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Accelerate LNP Manufacturing With Automated Process Development

  Manual LNP formulation introduces process variability that threatens particle quality and yield. As programs scale toward clinical production, maintaining strict control over CQAs becomes essential.

• 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.

• 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.

• Overcoming Limitations To Achieve Uniform Dosing

  An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

• Key Considerations For Selecting Fill/Finish Manufacturing Technologies

  Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.

• Design Success Combined With Expertise In Testing And Raw Material Selection

  Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

• Expanding Home-Based Care With A Next-Gen On-Body Delivery System

  As on-body delivery systems (OBDSs) enable the shift to patient-centric treatment, manufacturers must optimize the device and therapy formulation to minimize the risks and increase adherence.

• FAQs On The Revised EU GMP Annex 1: Volume 8

  Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.

• Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials

  The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.