Launch of the CEN Workshop 'Guidelines for Blood-Brain Barrier on-Chip Models for Drug Delivery Testing'

A new CEN Workshop is being established to build upon the innovative outcomes of the R&I project BiSCUIT, funded under the Horizon Europe programme. The project focuses on the validation of a dynamic and biomimetic blood-brain barrier model, integrating sensing features to allow a real-time evaluation of barrier formation and integrity maintenance.  

Traditional in vivo models often yield misleading results and have limited predictive value for clinical outcomes, whereas conventional in vitro models, such as 2D cultures and static systems, fail to accurately replicate the BBB, making them inadequate for predicting in vivo responses.


In this context, 'barrier-on-a-chip' technology represents an intermediate step between in vitro and in vivo investigations, capable of boosting drug development in the CNS domain while reducing the elevated costs of preclinical drug testing. These devices can reliably mimic the physiological microenvironment and integrate all necessary components (e.g. cells, extracellular matrix, external stimuli, and sensors) in a precisely controlled platform, while maintaining a high degree of biomimetic features, that are fundamental in the obtainment of consistent results that can predict the in vivo behavior. By using more and more realistic “barrier-on-chip” platforms, a strong reduction of the number of animals needed to perform in vivo screenings will be possible, in conformity with the 'Three Rs' principle (Replacement, Reduction, and Refinement) and the Directive 2010/63/EU. Therefore, these technologies represent an ethical alternative to animal testing while also offering direct economic benefits by reducing the costs associated with animal purchase, management, and treatment.

 

Standardization is essential in the following areas:

  1. Microfluidic parameters (flow rate, shear stress, and perfusion conditions).
  2. Cell sources and culture conditions (primary vs. iPSC-derived cells, endothelial co-cultures).
  3. Drug permeability testing protocols (standardized TEER thresholds, permeability coefficients).
  4. Validation with reference drugs (benchmarking against known human BBB permeability data).
  5. Data reporting guidelines (ensuring reproducibility and inter-laboratory comparability).


By implementing these standards, BBB-on-chip technology can become a regulatory-accepted tool for drug permeability testing, ultimately reducing the need for animal models and improving the efficiency of drug development.

 

The kick-off meeting for the Workshop will be an online meeting and is planned to take place remotely on 30th June 2025 from 9.30 am to 12.30 pm (CEST). To attend, please use this ZOOM meeting link and log in details:

Meeting ID: 984 5818 0441
Access code: 345173


All interested parties are invited to submit comments on the draft Project Plan using the commenting form below, to the Workshop Secretary, Fabio Rossi (Fabio.rossi@uni.com), by June 29th, 2025.


Download the documents:

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