Technology

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ELUTE® Fiber for Implantable Drug Delivery

TissueGen®‘s patented extrusion process for manufacturing ELUTE fiber occurs at room temperature.  Coupled with TissueGen’s proprietary drug protection technology, ELUTE fiber preserves the biological activity of incorporated agents so that the broadest range of pharmaceuticals and biologics ever possible remain viable when loaded to ELUTE® fiber.

Classes of Drugs

The possibilities for drug delivery enabled by TissueGen’s extrusion process are far-reaching. TissueGen has experience loading the following classes of drugs:

  • Pharmaceuticals (antibiotics to antineoplastic)
  • Biologics:
    • Growth factors (BDNF, GDNF, NGF, VEGF)
    • Immune proteins and enzymes (Fab IgG, lysozyme)
    • Oligonucleotides to whole viruses

Polymer Types

TissueGen has extruded many of the biodegradable polymers currently on the market as well as proprietary polymers for specific partners. Common polymer types used include:

  • Poly(L-lactic acid) [PLLA]
  • Poly(p-dioxanone) [PDO]
  • Blends with poly(ε-caprolactone) [PCL]
  • Poly(L-lactic-co-glycolic acid) [PLGA]
  • Poly(D,L-lactic acid) [PDLL]

ELUTE Fiber Format for Drug Delivery

Unlike traditional drug delivery formats such as microspheres and nanoparticles, ELUTE fiber provides both mechanical and pharmacological support from the same fiber – an incredible advantage over other means of drug delivery.

TissueGen’s bioresorbable fiber format offers many other unique advantages over traditional drug delivery methods:

  • Longer therapeutic window – The long cylindrical geometry of ELUTE fiber provides a slower drug release rate than a spherical geometry of the same radius, resulting in an inherently longer therapeutic window for similar drug concentrations.
  • Targets internal sites as the source – ELUTE fiber is both readily implantable and maintains positional stability, offering an unparalleled advantage when targeting specific tissue sites such as solid tumors.
  • Controlled, uniform distribution of drugs and biologically-based entities – ELUTE fiber extrusion is a very controlled process, yielding more uniform size distribution than typically found in other formats.
  • Tailored release of multiple drugs in a single fiber – Multi-layered, co-axial fibers may be readily produced with each layer containing a unique drug and polymer combination, thus enabling tailored release kinetics for multiple drugs in a single ELUTE fiber.
  • Removable as needed – ELUTE fiber may decrease the risk to patients because the fiber is removable in the rare case of an adverse reaction, whereas microspheres and nanoparticles are not.
  • Flexible Formatting – TissueGen can extrude ELUTE fiber in monofilament, hollow, bi-component (core-sheath) , and even gel-center filled formats. TissueGen can also extrude flat, rectangular or ribbon-shaped ELUTE fibers to suite customers’ unique requirements.

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