Fill & Finish

Expert Driven Drug Development

Aseptic Fill & Finish Processing Ensuring Contaminant-Free Drug Product

Landmark Bio’s fill & finish suite is fully qualified with unidirectional flow of materials and personnel. Housed within the suite is a Biological Safety Cabinet qualified to ISO5 particle specifications containing a CrystalTM M1 Filling Station. The suite also houses the Cytiva MicrocellTM filler, a fully closed and robotic filling station within a gloveless isolator.

Broad Fill-Finish Capabilities

  • The CrystalTM M1 filling station is an aseptic filling system that is functionally closed and designed to de-risk the fill & finish operation. The manual fill station operates with the AT-Closed Vial® technology and has been functionally qualified to fill volumes 0.5mL – 8mL, with further capabilities of 0.1mL – 50mL. Vials are filled with a high accuracy / precision (qualified to +/-5% fill volume) pump, capable of filling up to 300 vials per shift. The system can fill 1mL, 2mL, 6mL, 10mL, 20mL or 50mL AT-Closed Vial®s.
  • The Cytiva MicrocellTM is a fully closed and robotic filling station within a gloveless isolator, featuring VHP sterilization. The Microcell has fully disposable product contact surfaces and is capable of filling volumes between 1.0 – 50 mL. Filling up to 900 vials per shift, the system utilizes a high accuracy / precision pump, with automated fill weight verification, and is capable of filling 2R – 50R vials.

Dedicated Fill & Finish cGMP Suite Designed for Advanced Therapies

cGMP fill & finish operations are performed in a suite equipped with independent HEPA-filtered air handlers. Additional support rooms are utilized as appropriate and include Kitting, cGMP warehousing, controlled-rate freezing, and a freezer farm with multiple 2–8°C, –20°C and –80°C temperature control units.

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