ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

  As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

• Leveraging Integration At Each Phase Of A Drug Delivery System Project

  By forging deeper partnerships with customers, the full depth and breadth of our knowledge, experience and competencies can bring benefits at multiple levels. See how an integrated offering helps at each phase of a drug delivery system project.

• 2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance

  Review the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.

• Off-The-Shelf Vs. Novel Devices: Selecting A Drug Delivery System

  Whether bringing a novel therapy to market or altering current devices, companies must determine the best selection for administration without impacting drug efficacy, quality, and safety.

• Prefillable Syringe Plungers: A Solution For Low Temperature Storage

  Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.

• Reducing Environmental Impact At All Stages Of The Medicine Journey

  Explore how utilizing technologies like AI and digital twinning can inform decision-making at the R&D stage and how to optimize the delivery of the final drug product to patients with greener logistics.

• The Importance Of An Analytical Testing Strategy

  A proper and well-thought-out combination product testing strategy, rooted in applicable guidances in sync with scientifically sound methods, data capture, and reporting and retainment, is critical.

• 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.

• How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL

  A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.

• Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing

  This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.