ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

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  Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

• Expanding Opportunities For Inhaled Drug Delivery

  Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.

• USP <382>: Think Systems, Not Components

  This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.

• 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. 

• PHI And Medical Devices: What Device Manufacturers Need To Know

  Connected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.

• Safeguarding Biologic Integrity Through Enhanced Component Compatibility

  For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.

• Age-Appropriate Pediatric Formulation Development

  There is a significant variability in the pharmacokinetics of the same drug and dosage form between pediatric and adult populations, and the factors impacting drug bioavailability are different in children.

• Selecting A Strategic Partner For Your Combination Product

  It is imperative to choose an experienced partner that can ensure the highest quality products, minimize supply chain disruptions, and efficiently bring safe, effective drug products to patients.

• Effects Of Annex 1 Revisions On Manufacturing Operations

  The revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some of the key takeaways and interesting changes for risk management and contamination control strategies.

• Faster From Formulation To Fill/Finish

  Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.