ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• How To Address Challenges In Oncology Drug Containment

  Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance. 

• Vials Vs. Cryobags For Cryopreservation Of Therapeutically Relevant T Cells

  Explore how COP 50 mL vials could serve as a basis for cell therapies and storage solution to help facilitate the manufacture and commercialization of cell products.

• Overcoming Melt Processing Challenges

  Discover how a biodegradable polymer platform, easily applied with hot melt processing, enables processing at a relatively low temperature while preserving the potency of temperature-sensitive APIs.

• Patient-Centric Formulations In Pediatric Adherence

  Improving pediatric adherence requires age-appropriate formulations, taste-masking, and swallowability strategies. Regulatory, clinical, and technological insights help overcome barriers and support safer, more effective therapies for children across developmental stages.

• Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device

  Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

• Engineering Approaches To Respiratory Drug Delivery

  Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.

• How Approved Drugs Have Evolved Since The '70s

  Drugs have become more lipophilic and complex in structure over time. Innovative strategies are needed to improve the bioavailability of these new drugs.

• 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.

• Early Decisions To De-Risk The Transition To Combination Products

  The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?

• Harness High-Quality PBPK Modeling To Enhance Clinical Readiness

  Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.