Trelleborg Advances Contract Manufacturing Services for Drug-Device Combination Products
At MD&M West 2017, Trelleborg Sealing Solutions successfully highlighted its contract manufacturing services for delivering drug-device components – the combination of any two or three products categories: medical devices, drugs and/or biologics. These capabilities leverage deep engineering experience and pharmaceutical licensing to provide complete start to finish drug-eluting product development and manufacturing. Drug-eluting medical devices are designed to emit a drug over time to perform a certain action such as fighting infections or blocking cell proliferation.
“Trelleborg has a drug manufacturing facility in California that is licensed by the California Food and Drug Branch (FDB) to manufacture drug products. This facility can provide process engineering during development, lean manufacturing support, and the quality systems necessary for drug product manufacturing.”
The facility layout has been specifically designed for maximum flexibility and can deliver sought after workflows:
- Procuring an API
- Compounding the drug into the device
- Fabricating a drug component
- Assembling this component into a complete drug-device combination product
In addition, unique patented
GeoTrans® technology, a silicone extrusion innovation
, further enhances Trelleborg extensive portfolio of products. It produces superior geometric tubing in complex configurations.
Drew Rogers, Global Director, Healthcare & Medical for Trelleborg Sealing Solutions says, “As a global leader in engineered polymer solutions, we are well-suited to leverage deep expertise in material science, biochemistry, mechanical engineering, process design, and quality systems to meet our customers’ specific needs. We are thrilled to have further expanded our portfolio of silicone products, increased our ability to work with many bioabsorbable materials and manufacture drug-eluting components as well as complete drug-device combination products.”
Also, while at MD&M West, Trelleborg showcased its latest drug-device component products, anti-microbial tubing and hose as well as its advancements in LSR (liquid silicone rubber) technology to serve OEM medical and pharmaceutical manufacturers. Additional innovative applications supporting quality respiratory devices, peristaltic pumps and fluid handling devices, as well as versatile bioprocess containers & single-use products for drug delivery are expected to increase.