Laboratory for manufacturing medical devices using bio/nanomaterials

Infrastructures
Research areas
  • Physical Sciences
Available for external users?
Yes
Description

CIDETEC Nanomedicine’s platform supports the development, manufacturing, and scale-up of biomaterials and nanomedicine systems for use in medical devices, drug delivery, and advanced therapies.

It covers the entire development cycle, from laboratory-scale material synthesis to pilot-batch manufacturing in classified cleanroom facilities, including biological validation through cell culture.

The platform works with polymer-based hydrogels (both natural and synthetic), lipid and polymeric nanoparticles, non-viral gene therapy vectors, bioactive implant coatings, and materials for 3D bioprinting. Active development areas include orthopedics, ophthalmology, and skin applications.

By integrating synthesis, scale-up, and biological characterization within a single facility, the platform helps shorten development cycles and provides regulatory support through to CE marking.

Equipment

  • Synthesis reactors with capacities of up to 10 L
  • High-pressure homogenizer
  • Microfluidic reactors for continuous encapsulation
  • Pilot-scale encapsulation plant
  • Freeze-dryer (lyophilizer)
  • Classified cleanroom facilities for pilot-batch manufacturing, suitable for working with gene therapy vectors
  • Endotoxin testing and quantification equipment
  • Cell culture laboratory equipped for cytotoxicity, biocompatibility, and transfection assays
  • Physicochemical characterization equipment for biomaterials, including particle size, zeta potential, and rheology analysis

 

Services
  • Design and synthesis of biomaterials and nanostructured systems, including nanoparticles, hydrogels, liposomes, and coatings.
  • Scale-up of lipid and polymeric nanoparticles for drug delivery.
  • Development and scale-up of non-viral vectors for gene therapy.
  • Formulation of functional antimicrobial and anti-inflammatory coatings for implants.
  • Pilot-batch manufacturing in classified cleanrooms with endotoxin control.
  • Biological validation through cell culture, including cytotoxicity, biocompatibility, and transfection assays.
  • Physicochemical characterization of biomaterials and nanomaterials.
  • Regulatory development support toward CE marking of Class I–III medical devices.
  • Collaborative development and co-working during the prototyping and ideation phases of R&D projects.
Location

CIDETEC

Eskuzaitzeta Industrialdea, Oianguren, 5, 20160 Zubieta - Donostia / San Sebastián, SPAIN

Other info
Biomaterials and Tissue Engineering:
- Biotechnology, Processes and Biological Systems
- Healthcare Technologies

Application sectors

  • Pharmaceuticals and genetics
  • Healthcare and medical devices

Industrial plan

  • HAZI · Healthcare and Biomedical Industry