ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Is It Ever Too Soon To Start Your Performance Testing Assessment?

  Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

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  Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

• Nasal Inhalation Delivery – An Introduction Guide

  Unlock the potential of nasal inhalation for delivering active pharmaceutical ingredients by exploring the benefits of both liquid and dry powder formulations as companies drive innovation in the field.

• USP <788> Revisions And Why Packaging Matters More Than Ever

  Prepare for the upcoming USP <788> revisions by strengthening your particulate control strategy to support regulatory compliance, product quality, and patient safety across injectable drug products.

• New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory Pathway

  Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.

• 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.

• Self-Injection Of Biologics Made Easy

  Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.

• 5 Ways Pre-Filled Syringes Contribute To Better Patient Outcomes

  In our series on pre-filled syringes, we explore five key ways this delivery format is enhancing patient outcomes, not just through the medicine it contains, but through the device design itself.

• The Future Of Pharma Packaging Trends, Technologies, And Patient-Centric Solutions

  Pharmaceutical packaging must evolve alongside drug development to ensure stability, safety, and regulatory adherence, utilizing innovative designs to improve therapeutic outcomes and patient accessibility.

• Lyophilization Contract Manufacturing Services: What To Know

  Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.