SbD Guidelines

One of the main goals of the consortium is to develop guidelines to implement the SbD approach for nanobiomaterials, with focus on polymeric drug delivery systems, to consolidate these guidelines with industry and regulatory agencies to develop a comprehensive document for industry.

Our project aims to establish a comprehensive SbD Guideline for a product category among the nanomaterials, which is highly industry relevant and, being in the Life Science industry, situated in a future oriented growth market.

This SbD Guideline, by taking a systemic view, will be giving a broader picture and overview for European SMEs and European Research Institutes how to address SbD in R&D and industrial innovation processes. This SbD Guideline will build on and leverage the extensive work done over the last 10 years by the project coordinator EMPA, jointly with national and international partners.

The guidelines aim to support SMEs to:

• develop safe and sustainable products by gathering relevant knowledge and to make better choices in the product design;
• document “best practices” (i.e. by a systematic evaluation of benefits and risks of the nanoproduct) considering the whole life cycle of the nanomaterials;
• be prepared for the communication within the value chain (suppliers, customers), regulatory authorities and notified bodies;
• be prepared for the quality assurance process and regulatory affairs;
• understand the current knowledge gaps and initiate public research relevant for a safe design of polymeric NanoBiomaterials for drug delivery.

The SbD Guidelines will be elaborated based on:

• available current knowledge about the benefits and the risks of polymeric nanobio-materials for drug delivery;
• the experiences/results from the case studies;
• the results from NanoReg, NanoReg harmonized terminology for environmental health and safety assessment of nanomaterials and ProSafe and ProSafe SADO Matrix;
• and experiences of the industry.

The Guidelines will serve as theoretical, generic tool for implementing the SbD concepts, whereas the practical pilot implementation in the three industry case studies will give a practical approach and in an ideal case will serve as best practice model.

The Guideline and the case studies, together with the background information, will serve as knowledge package and offer pathways for innovators to define their specific strategy for future implementation.