New Workflow is First End-to-End Solution for Extrusion-Based Drug Implant Production

To meet growing demand for innovative drug delivery systems in the pharmaceutical industry, drug formulation scientists can now use the first commercially available, fully-integrated solution for polymer-based drug implant development and production using hot melt extrusion (HME). This new drug development workflow provides pharmaceutical manufacturers with a complete end-to-end manufacturing line from a single supplier.

The Thermo Scientific Pharma mini implant line is built around the Thermo Scientific Pharma mini HME twin-screw micro compounder. It provides drug developers, process manufacturing scientists and engineers with a continuous and fast production process designed to improve product quality, maximize operator safety and reduce the risk of contamination. This integrated production line is also designed to allow contract research and manufacturing organizations (CRO/CMO) to develop and optimize small-scale formulations before engaging in larger-scale production.

“With a single subcutaneous injection, advanced drug implants can release a therapeutic substance that can provide patients with improved drug compliance, effective disease treatment or controlled hormonal regulation for weeks or even months,” said Hanna Granö-Fabritius, senior business director, material characterization for Thermo Fisher Scientific. “Pharmaceutical manufacturers are seeking fast, reliable solutions for continuous production of novel drug delivery systems. Our new, automated implant line offers a hot melt extrusion solution designed to minimize formulation development time.”

The Thermo Scientific Pharma mini implant line incorporates a range of components in an innovative configuration. In addition to the Pharma mini HME micro compounder, components include:

• A containment valve to add the active pharmaceutical ingredient (API) and the polymer, designed to protect the operator from exposure to the API and preventing contamination of the API;

• A gravimetric feeder to deliver the API/polymer into the micro compounder for heating and mixing before the melt is extruded through a die that creates a continuous filament;

• New bi-axial lasers that measure the thickness or diameter of the filament to adjust the stretching or “take-off” speed of the conveyor belt; and

• Proprietary equipment that cuts the filament to a desired implant length while maintaining “roundness” without deforming the implant shape.

Find more information on the Thermo Scientific Pharma mini implant line here.