ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Key Considerations For Packaging Solutions For Cell And Gene Therapies

  Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.

• Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development

  The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.

• Have You Selected The Right Stopper For Your Lyophilized Drug Product?

  Component selection is a complex process. Packaging considerations should occur concurrent with drug development to mitigate risk at every step of the drug development process.

• Taking A Best Practice Approach To Contamination Control 

  Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.

• Safely Navigating The Transition From MDD To MDR

  If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

• Overcoming Wet Injection Challenges With Human-Centric Design

  By understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices.

• Accelerate LNP Manufacturing With Automated Process Development

  Manual LNP formulation introduces process variability that threatens particle quality and yield. As programs scale toward clinical production, maintaining strict control over CQAs becomes essential.

• 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.

• Expanding Subcutaneous Design Brick By Brick

  Biologics are growing more complex. But what if the syringe itself could unlock new possibilities? Discover the technology “bricks” quietly reshaping subcutaneous drug delivery.

• Pharmaceutical Nanotechnology: What To Know

  Here is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.