ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Prefillable Syringe Plungers: A Solution For Low Temperature Storage

  Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.

• FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study

  Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.

• Planning For The Return And Destruction Of Your Product

  Aspects of accountability, reconciliation, return, and destruction require significant effort to compile historical data. A little up-front planning can remove many future complications.

• Rare Diseases And The Integrated CDMO Support System

  Champion the rare‑disease community by advancing development models built on precision, continuity and global coordination that ensure every dose reaches the patients who need it most.

• Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials

  The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.

• Specializing In Small And Early-Stage Partners, Not Just Small Batches

  Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

• Planning Your Packaging For A Seamless Transition From Clinic To Launch

  Explore how clinical and commercial teams should work together for clinical supply packaging, how the COVID-19 pandemic has changed things, and what to consider when looking for a packaging partner.

• Cryobag Container Development For Cell & Gene Therapies

  ISR Reports addresses the logistical challenges faced by developers of cell and gene therapies regarding cold chain and cryopreservation.

• Winning The Race To FPI With Early Randomization And Trial Supply Management

  Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences. 

• Logistics, Transport Challenges Require Complex Solutions

  The pandemic created additional obstacles for the clinical supply chain. Ensuring continued clinical trial operation requires an optimal management solution for clinical material supply.