GMP PILOT PLANT

Facing a Challenge

The production of innovative pharmaceuticals in quantity and quality required for SMEs to enter clinical trials remains a challenge:

  • Medium size companies with limited R&D facilities use their existing manufacturing plants, which are too big and too busy for R&D purposes.
  • Small companies lack of resources to up-scale and implement GMP
    manufacturing.
GMP PILOT PLANT

Providing a Solution

The GMP Pilot Plant will provide campaign production of:

  • Lyophilizates – Non-sterile and sterile.
  • Aseptic filling of monodosis.
GMP PILOT PLANT

Our value proposition

The first pilot plant in EU specialized in the development of polymer based nanopharmaceuticals
dedicated to early clinical development.

  • Flexible to the customer needs:
    Campaign production will allow the implementation of different processes in the same facilities.
  • Cost-effective: Includes small equipment to produce only required amount of doses.
  • Dedicated to technology transfer from lab to pilot scale – Unlike CMOs which are interested in the production of big batches.

The Pilot Plant

The Pilot Plant has been established in San Sebastian
in the R&D building dedicated to the Nanomedicine Area of CIDETEC. 165 m2 pilot plant operating under GMP.