ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

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  Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

• The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine

  The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.

• Gliding Towards De-Risked Combination Product Development

  Learn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.

• Partnering With Clinicians To Improve Pediatric Formulation Development

  Greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.

• A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS

  Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.

• Data-Driven Innovation Is Drug Delivery's Next Evolution

  To mitigate inherent risks like inconsistent dosing, user error, and low adoption due to complex usage procedures, technological innovation in delivery devices is best guided by lessons from the past, including user feedback and follow-on learnings from market data.

• Quality By Design Principles For Analytical Methods

  A QbD approach was used to solve a high-performance liquid chromatography analytical method problem where impurity peaks had shifting retention times, making identification and quantitation problematic.

• Small-Scale Aseptic Filling Technology Considerations

  Small-scale aseptic filling presents a unique set of challenges. Learn what to look for when evaluating small-scale aseptic filling technology.

• An Insoluble Problem? Oral Drug Solubility With Functional Polymers

  Review the basics of solubility enhancement and the formulation and manufacture of products that enhance solubility and common questions on the topic.