Pharma Focus Asia

New Drug Development Workflow Designed for Extrusion-Based Drug Implant Production

The Thermo Scientific Pharma mini implant line, first end-to-end solution, is an automated, integrated system designed for continuous production of drug implants.

Drug formulation scientists can use the first commercially available, fully integrated solution for polymer-based drug implant development and production using Hot Melt Extrusion (HME) to meet growing demand for innovative drug delivery systems in the pharmaceutical industry.

Pharmaceutical manufacturers can get a complete end-to-end manufacturing line from a single supplier through new drug development workflow.

The Thermo Scientific Pharma mini implant line is built around the Thermo Scientific Pharma mini HME twin-screw micro compounder.

To enhance product quality, maximize operator safety and reduce the risk of contamination, Thermo Scientific Pharma mini implant provides drug developers, process manufacturing scientists and engineers with a continuous and fast production process.

This integrated production line is also designed to allow Contract Research and Manufacturing Organisations (CRO/CMO) to develop and optimise 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.

This new automated implant line offers a hot melt extrusion solution designed to minimize formulation development time as pharmaceutical manufacturers are seeking fast, reliable solutions for continuous production of novel drug delivery systems.

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.

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