ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Maintaining Sterility Through Precise Component Design And Manufacture

  Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.

• Sterile Injectable Therapies: Revolutionizing Lifecycle Management

  The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.

• Functional Performance Of Stoppers To Support Multipuncture Use

  Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.

• 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.

• Small Is Powerful And Sustained

  Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

• Stability Chambers: Testing, Equipment, And Uses

  Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.

• Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products

  Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.

• 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.

• Nanosuspension Dosage Forms: Product Development & Scale Up

  For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.

• Closing The Duration Gap In FDA-Approved Long-Acting Contraceptives

  A gap exists between three months and three years in FDA-approved long-acting contraceptives (LACs). A microsphere formulation enables sustained release over a six to twelve-month period.