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Scientific objectives

Production of three nanopharmaceuticals

Three different nanopharmaceuticals will be produced within the project after achieving GMP certification for the plant and completing the technology transfer process for each production.
The three of them were selected on the basis of their “technologies readiness level” (TRL) 4-5 and positive commercial evaluation (scalability and intended market).

A short interfering RNA (siRNA) nanoformulation for the topical treatment of ocular pain associated with dry eye syndrome (DES).

A HIV nanovaccine intended for intranasal administration.

Hyaluronan spheres, a treatment for interstitial cystitis/painful bladder syndrome (IC/PBS).

 

Integration of microfluidics in the plant
  • INCREASED PROCESS CONTROL: high degree of parameter accuracy (flow, temperature, mixing time, reaction time).
  • INCREASED PROCESS SAFETY: the quantity of reagents reacting at any time is small giving rise to increased process safety compared to batch reactors.
  • SMALL FOOTPRINT: GMP production of Phase III batches of API’s have been performed within installations housed in fume cupboards.
  • RAPID: The ease with which reaction conditions can be assessed at the lab-scale enables process understanding to be collected rapidly.
  • ROBUST : Processes developed are not operator dependent.
  • ECONOMICAL: Efficient thermal control and use of static mixer technology has the potential to reduce the operating costs when compared to traditional batch approaches.
 

Highly advanced characterization techniques

Asymmetrical Flow Field Flow Fractionation (A4F) is increasingly used as a mature separation method to size sort and characterize nanoparticles in native conditions, and offers the possibility to analyze a wide variety of macromolecules and particles ranging from the nanometer to the micrometer range with high resolution.

This analytical methodology will be used to control/validate the process and finally to characterize the final batches in compliance with GLP, and will complement other standard methods already available in the pilot plant (DLS, SEC, HPLC…).

This technique has been already used at lab-scale, but NanoPilot will implement it for the quality control of the production processes.

  • Accurate, high-resolution nanoparticle size distribution analysis.
  • Investigation of nanoparticle aggregation in native conditions.
  • Separation of the unbound constituents of the functional nanoparticles.
  • Determination of the optical features of the nanoparticles, separated from other dispersion component and of the correlation of spectroscopic properties with nanoparticle size.
  • Chemical composition and quantification.