ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Scaling Safe, Consistent Drug Delivery in Modern Care

   Assistive drug delivery technologies, including wearable injectors, smart infusion systems, and guided delivery tools, help standardize dosing, reduce variability, and expand access across care settings.

• Small Is Powerful And Sustained

  Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

• Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway

  Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.

• 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.

• The Challenges And Opportunities Of Real-World Evidence

  The FDA's Real-World Evidence framework addresses challenges in using Real-World Data for regulatory decisions, emphasizing data reliability, bias management, and successful case studies.

• Decoding the FDA Guidance on Essential Drug Delivery Outputs

  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

• Container Closure Integrity: A Risk-Based Approach

  Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.

• How Dermal Delivery Platforms Are Transforming Tomorrows For Patients

  Skin delivery platforms expand therapies by boosting convenience, stability, and adherence. Integrated formulation, device, and manufacturing development is key to confidently scale.

• Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1

  Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.