ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Stopper Functionality – Key Considerations

  When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.

• Engineering Advances In Needle Geometry To Accommodate Viscous Biologics

  Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.

• Considerations In Formulation Development Of Injectable Solutions

  Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.

• Accelerate LNP Manufacturing With Automated Process Development

  Manual LNP formulation introduces process variability that threatens particle quality and yield. As programs scale toward clinical production, maintaining strict control over CQAs becomes essential.

• De-Risking The Transition From Vial To Drug-Device Combination Product

  When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

• The Future Of CDMOs: Aseptic Filling Solutions For Growth And Innovation

  The rapid rise of highly targeted cell and gene treatments requiring small batch production necessitates a new path forward for biologics manufacturing and directly impacts the CMO/CDMO landscape.

• Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing

  This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

• Early Solid Form Screening To Guide Drug Development

  Conducting solid form screening early can help your team select and isolate the ideal lead polymorph to ensure manufacturability and stability while avoiding costs and hiccups down the road.

• Is It Ever Too Soon To Start Your Performance Testing Assessment?

  Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

• Selecting Container Closure Components: A Data-Driven Approach To CCI

  Discover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.