INSIGHTS ON DOWNSTREAM MANUFACTURING

DOWNSTREAM MANUFACTURING SOLUTIONS

  • A pre-verified delivery platform eliminates redundant testing, simplifies regulatory submissions, and optimizes inventory management, allowing teams to focus on drug-specific performance.

  • Leverage a pre-verified, integrated syringe platform. Accelerate timelines and reduce costs by eliminating drug-independent testing while streamlining regulatory submissions through one source.

  • Lightly used Bausch Advanced Technologies isolated filling and closing machine, type 515, currently set up for 5mL BD Luer Syringes and Luer Caps, speeds up to 30/minute. Capable of handling 1mL to 30mL syringes with change parts at additional cost, 3 phase, 208 volt, 60 hertz, 14 kw, serial# 515031, built 2021.

  • Unused Watson-Marlow Flexicon (WMFTS) vial filler, Type Cellefill Ibio, designed for biohazard applications (OEB Level 3-4). Fills up to 25 vials per minute with Flexicon integrated peristaltic pump infeed. Features IPC via built-in load cell with automatic feedback, stoppering, and crimp capping for flip-top caps with built-in force measurement. Pick-and-place discharge, EM monitoring, SQL database data collection, and automatic vial size adjustment. Built 2022.

  • Unused Groninger Aseptic Vial Filling Line, speeds up to 150 vials/minute. Line is designed to CE-norms. Set up for 3 mL, 5 mL with 13mm neck size, 10R, 10Ml, with 20mm neck size, speeds up to 150 vials/minute, 20H, with 20mm neck size, speeds up to 60 vials/minute, and 30mL with 20mm neck size range, speeds up to 50 vials/minute.