ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Key Considerations When Choosing A Device For Dry Powder Nasal Delivery

  Building on previous discussions, here we discuss the benefits of nasal delivery and the challenges of developing dry powder formulations by focusing on key devices that can be used for delivering dry powder nasal dosage forms.

• From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

  Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

• Simultaneous Spray Drying For Combination Dry Powder Inhaler Formulations

  Three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.

• Evolution Of Novel Polymers To Overcome Limits In Sustained Drug Delivery

  Degradable polymers evolved from aliphatic polyesters to nitrogen-bearing biomaterials such as polyurethanes and polyester amides. Explore a brief history of the development of PEA polymers.

• Streamline Your Fill And Finish Process Of Ready-To-Use Cartridges

  An optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics to improve efficiency in pharmaceutical production.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization

  Biologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. As these therapies often require low annual volumes, the associated device manufacturing strategy must also fit commercial expectations, even at those volumes. 

• Containment Solutions To Help Emerging Biologic Companies

  Set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.

• Maximize Global Regulatory Collaboration

  When marketing a combination product globally, pharmaceutical manufacturers and drug delivery technology providers must have a collaborative infrastructure based on strategic alignment, proactive regulatory awareness, lifecycle support, and continuous improvement globally.

• 4031 Ready Methods Reduce E&L Timelines

  An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.