ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Vial Containment Systems For Gene And Cell Therapies

  CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.

• Design Success Combined With Expertise In Testing And Raw Material Selection

  Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

• Reformulation Of A Complex, High-Drug-Load, Modified Release Dosage Form

  What if you could limit and position a formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance?

• The Role Of Psychological Principles In Med Device Training Design

  Explore how psychological principles can shape the design of medical device training and the significance of these principles in developing an effective training protocol for new medical device users.

• White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges

  Explore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.

• Understanding Of Amorphous Solid Dispersions & Their Downstream Development

  Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.

• 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.

• Addressing Glass Particulates In Injectable Drug Formulations

  Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

• Pediatric Dosage Form Development: Program Design And Formulation Development

  Explore key considerations to successfully bridge from initial concept of pediatric program design and formulation development strategies into later stages of development and through to commercialization.