ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Keys To Driving Consistent Quality In Contract Manufacturing

  Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed and launched. This article discusses key ingredients to robust and advanced quality planning that are essential to quality in contract manufacturing.

• Functional Performance Of Stoppers To Support Multipuncture Use

  Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.

• Application Of A Novel Temperature Shift Process For Particle Engineering

  Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.

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  Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

• How Various Clinical Study Stages Influence Oral Formulation Approach

  It’s important for pharmaceutical and biopharmaceutical companies to implement a phase-appropriate approach for early formulation development and later-stage commercial development.

• FAQs On The Revised EU GMP Annex 1: Volume 6

  The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.

• Deploying A Circular Economy For Medical Devices

  A circular economy prioritizes sustainability throughout the supply chain by eliminating waste, circulating products and materials, and regenerating nature.

• Navigating PFAS "Forever Chemicals" In Medical Devices - What's On The Horizon

  Gain an understanding of PFAS, their properties, environmental impact, health risks, and regulatory challenges, focusing on the specific implications for the medical device industry.

• Factors To Consider When Selecting A CDMO For Complex Injectables Development And Manufacture

  The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities and operations to adopt GMP practices with a "laboratory setting."

• 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.