ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Advancing A LNP Formulation To Clinical And Commercial Manufacturing

  Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

• Leachables Method Development, Validation And Relevant ICH References

  It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

• How Lipid Nanoparticles Overcome Solubility Challenges

  More than 80% of NCEs are poorly soluble compounds. Overcoming this challenge using lipid nanoparticles is essential to move your drug product through the pipeline and into the market.

• Achieve Release Profiles And Select Excipients For Formulation Development

  The formulation and manufacture of modified-release OSD forms are highly specialized. Review considerations for planning and executing a successful modified release oral solid dosage formulation.

• Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization

  While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.

• Faster From Formulation To Fill/Finish

  Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.

• Improve Solubility And Spray Drying Throughput For Brick Dust Compounds

  This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

• The Challenges And Opportunities Of Real-World Evidence

  The FDA's Real-World Evidence framework addresses challenges in using Real-World Data for regulatory decisions, emphasizing data reliability, bias management, and successful case studies.

• Harnessing The Power Of New Approach Methodologies

  Human-relevant models are reshaping safety and efficacy decisions, but impact depends on selecting the right tools, integrating evidence, and turning complex data into clear, decision‑ready insights.

• 4 Factors Affecting Solubility Of Drugs

  Improper drug solubility can lead to suboptimal drug delivery and absorption, resulting in ineffective drug efficacy and side effects, so solubility must be evaluated in the early stages of drug discovery.