ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Patient Adherence With A Novel Dosage Form

  A sprinkle formulation helps patients with tremors or dysphagia take medication more easily, improving adherence, comfort, and care through a novel, FDA-approved oral granule format.

• 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.

• 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.

• How To Ensure Correct Component Selection When Outsourcing To A CMO

  A CMO-recommended lyophilization stopper was contributing to several operational inefficiencies, including sticking and interlocking of stoppers during filling operations. Requalification work was required to make a change.

• High-Dose Delivery: Integration And Performance

  High-viscosity therapies bring new delivery challenges. Explore how needle, syringe, and device design affect injection performance, reliability, and user experience.

• Understanding Injectable Drug Container Closure Systems

  Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

• Realizing The Promise Of New Approach Methodologies (NAMs)

  NAMs are transforming risk assessment. Learn how integrating advanced in vitro models and computational tools can improve efficiency, reduce costs, and strengthen regulatory decision-making.

• 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.

• Guidelines For Selecting A Medical Device Contract Manufacturer

  Consider these guidelines when evaluating potential device contract manufacturers to choose one that will be the best fit for your company.

• Streamline Microbial Process Development To Reach Toxicology Trials Faster

  For biopharmas looking to outsource their early phase development, consider working with a CDMO partner that has the knowledge and experience to navigate microbial fermentation and complex process development.