Services

In our shared development facility in the scientific heart of the Brainport region, entrepreneurs and academics work together on the development, production and assembly optimization of bio- and biocompatible materials, functional testing, the assessment and prediction of implant functionality as well as on solving scaling-up challenges for clinical production in an ISO 13485 compliant environment. With the opening of our shared pilot production factory in 2024, we will boost the industrial production of biomaterials and biodegradable implants.

Smart Biomaterials Consortium provides support through the following infrastructure and services:

  • Shared development lab facility
  • Shared pilot production facility
  • Contractresearch
  • Product development
  • Training and support in quality management and regulatory requirements (In collaboration with Holland Innovative)
  • Subsidy application support (in collaboration with Vind subsidies)

Shared development lab facilities

  • 165 sqm total footprint; consisting of 65 sqm material validation lab and 100 sqm ML2 certified cell culture lab
  • Qualified equipment for the translation of basic research into production ready product
  • ISO13485 compliant quality management system.
  • Training and support in quality management and regulatory issues

Engineering & Prototyping

  • State-of-the-art Electrospinning (Vivolta)
  • Automated material formulation with use of a pipetting robot (Waters Andrew+)
  • Verification testing

Product development & entrepeneurship

  • Development strategy and planning
  • Product development
  •  ISO13485 QMS blueprint and QA support
  • Network 

Enabling Technologies

  • Cell culture facilities
  • Cell-Biomaterial interaction analysis
  • Cellular and biochemical assays such as toxicity, proliferation, live/dead, ELISA, etc.
  • Extensive fluorescent microscopy platform with a screening widefield epifluorescent microscope with optional digital imaging correlation (Thunder Imager Live Cell – Leica), a confocal scanning laser microscope with white-light laser (Stellaris 5 – Leica)
  • Mechanical analysis of biomaterials with rheometer and tensile tester
  • Multi-mode reader with absorbance, fluorescence and luminescence (Spark Cyto 400 – Tecan)
  • Desktop SEM (Phenom G2 XL – ThermoFisher) with EDX
  • High performance pilot freeze dryer (Epsilon 2-10D LSCpIus MC Basic – Christ)

Shared pilot production facilities

  • Four GMP Grade C / ISO 7 cleanrooms
    • 50 m2 up to 125 m2
    • Dedicated gowning per cleanroom
    • Dedicated monitored storage facility per cleanroom
  • Monitoring of critical parameters (including particles, differential pressure, microbiological viable particles, temperature, relative humidity, CO2 concentration)
  • Supporting services including cleaning, utility management, general gowning. 

Quality management and quality control

  • Supporting (GMP) procedures for a.o. gowning, cleaning, classification, validation, and deviation management and monitoring
  • Shared QC-laboratory 

Training and support in Quality Management and regulatory issues (in collaboration with partners)

  • Product and process development
  • Regulatory expertise to enable early clinical trials

Enabling Technologies

  • Electrospinning
  • 3D (Bio)Printing
  • Coating technologies
  • Polymer technologies
  • Mechatronic engineering
  • Cell-based analyses
  • Microscopy
Microscope SBMC research
SBMC test tubes
SBMC laboratories