Safe innovation approach: Towards an agile system for dealing with innovations

Soeteman‐Hernández, Lya G.; Apostolova, Margarita D.; Bekker, C.; Dekkers, Susan; Grafström, Roland C.; Groenewold, Monique; Handzhiyski, Yordan; Herbeck-Engel, Petra; Hoehener, K.; Karagkiozaki, V.; Kelly, Sean; Kraegeloh, Annette; Logothetidis, S.; Micheletti, Christian; Nymark, Penny; Oomen, Agnes G.; Oosterwijk, Thies; Llopis, Isabel Rodríguez; Sabella, Stefania; Jiménez, Araceli Sánchez; Sips, A. J. A. M.; Suárez-Merino, Blanca; Tavernaro, Isabella; Engelen, Jeroen; Wijnhoven, Susan; Noorlander, C.W.

doi:10.1016/j.mtcomm.2019.100548

Cited by 50 publications

(70 citation statements)

References 27 publications

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“…However, the approach should not be seen as a warranty of complete safety, because absolute safety is unreachable (Cobaleda-Siles et al, 2017;Hjorth et al, 2017;van de Poel and Robaey, 2017), and should therefore be considered as a design strategy (van de Poel and Robaey, 2017) since the past showed that each nanomedicine has to be taken as caseby-case (McNeil, 2009). As for the general SbD concept, it has no legal binding and does not replace regulatory requirements (Soeteman-Hernandez et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

“…Its goal is to "reduce uncertainties and risks of human and environmental safety of nanotechnology, starting as early as possible during the innovation process, on the basis of mandatory and voluntary safety and efficacy compliance requirements" (Soeteman-Hernandez et al, 2019). The main elements of the general SbD approach are: (1) it uses a stage-gate innovation approach, (2) it is based on three pillars, which are Safe materials and products, Safe production, and Safe use and end-of-life; (3) it includes SbD action for maximizing safety while maintaining functionality, and (4) it is integrated into a Safe Innovation Approach (see extensive description in Kraegeloh et al, 2018;Soeteman-Hernandez et al, 2019). Below we show how we changed or adapted these elements of the general SbD approach to nanomedicines (the comparison can be seen in Table 1).…”

Section: Adaptation Of the General Sbd Approach To Nanomedicinesmentioning

confidence: 99%

“…The concept of Safe-by-Design (SbD) was addressed in the field of nanotechnology because of the continuous uncertainty about the potentially harmful effects of nanomaterials on humans and the environment. Its implementation started with the Dutch NanoNextNL program 1 and the European NANoREG project and was further developed by the H2020 ProSafe initiative and H2020 NanoReg2 project (Soeteman-Hernandez et al, 2019). Since then, an increasing number of European Union projects focused on SbD for nanomaterials (Lynch, 2017).…”

Section: Introductionmentioning

confidence: 99%

“…Even though various concepts of SbD coexist, they share the purpose of assessing safety as early as possible in the innovation process of a nanomaterial or nanoproducts. They aim at reducing adverse effects on human health and the environment by altering nanoproduct design (Soeteman-Hernandez et al, 2019) and by ensuring safety along its lifecycle (Bottero et al, 2017;Kraegeloh et al, 2018). The SbD concept is therefore different from conventional risk assessment approaches, which only consider safety when the product is already fully developed (Schwarz-Plaschg et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

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A Methodological Safe-by-Design Approach for the Development of Nanomedicines

Schmutz

Borges

Jesus

et al. 2020

Front. Bioeng. Biotechnol.

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Safe-by-Design (SbD) concepts foresee the risk identification and reduction as well as uncertainties regarding human health and environmental safety in early stages of product development. The EU's NANoREG project and further on the H2020 ProSafe initiative, NanoReg2, and CALIBRATE projects have developed a general SbD approach for nanotechnologies (e.g., paints, textiles, etc.). Based on it, the GoNanoBioMat project elaborated a methodological SbD approach (GoNanoBioMat SbD approach) for nanomedicines with a focus on polymeric nanobiomaterials (NBMs) used for drug delivery. NBMs have various advantages such as the potential to increase drug efficacy and bioavailability. However, the nanoscale brings new challenges to product design, manufacturing, and handling. Nanomedicines are costly and require the combination of knowledge from several fields. In this paper, we present the GoNanoBioMat SbD approach, which allows identifying and addressing the relevant safety aspects to address when developing polymeric NBMs during design, characterization, assessment of human health and environmental risk, manufacturing and handling, and combines the nanoscale and medicine field under one approach. Furthermore, regulatory requirements are integrated into the innovation process.

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Section: Discussionmentioning

confidence: 99%

Section: Adaptation Of the General Sbd Approach To Nanomedicinesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

A Methodological Safe-by-Design Approach for the Development of Nanomedicines

Schmutz

Borges

Jesus

et al. 2020

Front. Bioeng. Biotechnol.

Self Cite

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show abstract

“…The principle behind SbD includes the safety assessment of nanomedicines as early as possible in their innovation process and throughout their lifecycle by designing out the physicochemical properties with an adverse effect on human health and the environment (Bottero et al, 2017;Soeteman-Hernandez et al, 2019). Several concepts of SbD have arisen from the European projects mentioned above.…”

Section: Introductionmentioning

confidence: 99%

How the Lack of Chitosan Characterization Precludes Implementation of the Safe-by-Design Concept

Marques

Som

Schmutz

et al. 2020

Front. Bioeng. Biotechnol.

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Efficacy and safety of nanomedicines based on polymeric (bio)materials will benefit from a rational implementation of a Safe-by-Design (SbD) approach throughout their development. In order to achieve this goal, however, a standardization of preparation and characterization methods and their accurate reporting is needed. Focusing on the example of chitosan, a biopolymer derived from chitin and frequently used in drug and vaccine delivery vector preparation, this review discusses the challenges still to be met and overcome prior to a successful implementation of the SbD approach to the preparation of chitosan-based protein drug delivery systems.

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The Frontier of Plastics Recycling: Rethinking Waste as a Resource for High‐Value Applications

Mangold

Vacano

2022

Macro Chemistry & Physics

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Following the circular economy hierarchy of reduce and reuse, recycling is the third layer to close the loops for materials and decouple their value from consumption. Polymeric materials ("plastics") are in principle well suited for recycling, as they can be reprocessed with relatively low energy input as a material, cleaved back into their monomers or converted back to feedstock. Today, these approaches still fall short in quantitatively diverting waste towards reuse. This perspective describes the industry challenges for recycling back into high value applications of polymers, and the portfolio of existing and emerging technology solutions. Sustainable design of products and polymers, recycling technologies, appropriate business models, and enabling technologies converge at the frontier of plastics recycling, for a transformation of the industry towards circularity and greenhouse gas emission neutrality.

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Safe innovation approach: Towards an agile system for dealing with innovations

Cited by 50 publications

References 27 publications

A Methodological Safe-by-Design Approach for the Development of Nanomedicines

A Methodological Safe-by-Design Approach for the Development of Nanomedicines

How the Lack of Chitosan Characterization Precludes Implementation of the Safe-by-Design Concept

The Frontier of Plastics Recycling: Rethinking Waste as a Resource for High‐Value Applications

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