Implants and Drug Delivery
Implants and Drug Delivery, formerly trademarked as "Delivery Science", specializes in melt extrusion blending and forming of highly regulated materials, including implantable and drug delivery polymers used in combination devices and pharmaceuticals. We offer formulation, feasibility, process development, scale up and manufacturing services in a cGMP clean room environment.
Our experience includes process Design of Experiment (D.O.E.), validation batches, supplies for human clinical trials Phase I, II, and III) and samples under cGMP conditions for bioequivalency studies.
- Formulation – Material Selection
- Feasability - Small Batch Production
- Process Development - Non-GMP Process Definition
- GMP Trials – Clinical Supply
- Scale-Up - Maximization of Throughput
- Validation - Process & Test Methods
- Production – Implement Manufacturing Protocols
Bioactive/Pharmaceutical melt extrusion is performed in a cGMP clean room production facility using twin screw extruders that incorporate cGMP design for medical and pharmaceutical applications. Twin screw extruders have several advantages such as easy material feeding, high kneading and dispersing capacities, and short transit time. Screw elements, screw rotation and screw speeds can be custom designed for the formulation being produced.