ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls

  Utilizing off-the-shelf (OTS) devices for drug delivery can offer significant advantages to development programs in timeline and risk mitigation. Understand the design control responsibilities of a sponsor when using OTS devices.

• A Practical Packaging Components Checklist For Emerging Biotechs

  A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

• 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.

• A Step Change In Pharmaceutical Glass Packaging Innovation

  Valor Glass represents a significant, and much needed, step forward for glass innovation. Review the findings and learn how an aluminosilicate formulation can lower your glass vials' extractables profile.

• Developing An Effective Lipid Nanoparticle Formulation Process For Small Molecule And Biologicals Delivery

  Lipid nanoparticles (LNPs) are a versatile formulation technology used by drug development teams to deliver a variety of small/large molecules, peptides, and biologicals.

• Recent Innovations And Enhancements To Pharmaceutical Spray Drying

  Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.

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  Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

• Delivering The Promise Of Gene Therapy

  Gene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.

• Capsule Formulation Development: From Dosage Forms To Filling

  Capsules are tasteless and easy to take, offer streamlined development timelines, and simplicity of manufacturing. Discover capsule formulation development and the benefits of capsule dosage forms.

• Overcoming A Failed Design Verification Test For Your Delivery Device

  If a drug delivery device fails a design verification test, the consequences can be lost revenue for the pharma company and delays for patients. Explore how to eliminate design verification failure.