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.