On the issue of transparency and reproducibility in nanomedicine

Hon S. Leong; Kimberly S. Butler; C. Jeffrey Brinker; May Azzawi; Steve Conlan; Christine Dufés; Andrew Owen; Steve Rannard; Chris Scott; Chunying Chen; Marina A. Dobrovolskaia; Serguei V. Kozlov; Adriele Prina-Mello; Ruth Schmid; Peter Wick; Fanny Caputo; Patrick Boisseau; Rachael M. Crist; Scott E. McNeil; Bengt Fadeel; Lang Tran; Steffen Foss Hansen; Nanna B. Hartmann; Lauge P.W. Clausen; Lars M. Skjolding; Anders Baun; Marlene Ågerstrand; Zhen Gu; Dimitrios A. Lamprou; Clare Hoskins; Leaf Huang; Wantong Song; Huiliang Cao; Xuanyong Liu; Klaus D. Jandt; Wen Jiang; Betty Y.S. Kim; Korin E. Wheeler; Andrew J. Chetwynd; Iseult Lynch; Seyed Moein Moghimi; André Nel; Tian Xia; Paul S. Weiss; Bruno Sarmento; José das Neves; Hélder A. Santos; Luis Santos; Samir Mitragotri; Steve Little; Dan Peer; Mansoor M. Amiji; Maria José Alonso; Alke Petri-Fink; Sandor Balog; Aaron Lee; Barbara Drasler; Barbara Rothen-Rutishauser; Stefan Wilhelm; Handan Acar; Roger G. Harrison; Chuanbin Mao; Priyabrata Mukherjee; Rajagopal Ramesh; Lacey R. McNally; Sara Busatto; Joy Wolfram; Paolo Bergese; Mauro Ferrari; Ronnie H. Fang; Liangfang Zhang; Jie Zheng; Chuanqi Peng; Bujie Du; Mengxiao Yu; Danielle M. Charron; Gang Zheng; Chiara Pastore

doi:10.1038/s41565-019-0496-9

On the issue of transparency and reproducibility in nanomedicine

Hon S. Leong, Kimberly S. Butler, C. Jeffrey Brinker, May Azzawi, Steve Conlan, Christine Dufés, Andrew Owen, Steve Rannard, Chris Scott, Chunying Chen, Marina A. Dobrovolskaia, Serguei V. Kozlov, Adriele Prina-Mello, Ruth Schmid, Peter Wick, Fanny Caputo, Patrick Boisseau, Rachael M. Crist, Scott E. McNeil, Bengt FadeelLang Tran, Steffen Foss Hansen, Nanna B. Hartmann, Lauge P.W. Clausen, Lars M. Skjolding, Anders Baun, Marlene Ågerstrand, Zhen Gu, Dimitrios A. Lamprou, Clare Hoskins, Leaf Huang, Wantong Song, Huiliang Cao, Xuanyong Liu, Klaus D. Jandt, Wen Jiang, Betty Y.S. Kim, Korin E. Wheeler, Andrew J. Chetwynd, Iseult Lynch, Seyed Moein Moghimi, André Nel, Tian Xia, Paul S. Weiss, Bruno Sarmento, José das Neves, Hélder A. Santos, Luis Santos, Samir Mitragotri, Steve Little, Dan Peer, Mansoor M. Amiji, Maria José Alonso, Alke Petri-Fink, Sandor Balog, Aaron Lee, Barbara Drasler, Barbara Rothen-Rutishauser, Stefan Wilhelm, Handan Acar, Roger G. Harrison, Chuanbin Mao, Priyabrata Mukherjee, Rajagopal Ramesh, Lacey R. McNally, Sara Busatto, Joy Wolfram, Paolo Bergese, Mauro Ferrari, Ronnie H. Fang, Liangfang Zhang, Jie Zheng, Chuanqi Peng, Bujie Du, Mengxiao Yu, Danielle M. Charron, Gang Zheng, Chiara Pastore

Research output: Contribution to journal › Letter › peer-review

128 Scopus citations

Abstract

Following our call to join in the discussion over the suitability of implementing a reporting checklist for bio–nano papers, the community responds.

Original language	English (US)
Pages (from-to)	629-635
Number of pages	7
Journal	Nature Nanotechnology
Volume	14
Issue number	7
DOIs	https://doi.org/10.1038/s41565-019-0496-9
State	Published - Jul 1 2019

ASJC Scopus subject areas

Bioengineering
Atomic and Molecular Physics, and Optics
Biomedical Engineering
Materials Science(all)
Condensed Matter Physics
Electrical and Electronic Engineering

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10.1038/s41565-019-0496-9

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Leong, H. S., Butler, K. S., Brinker, C. J., Azzawi, M., Conlan, S., Dufés, C., Owen, A., Rannard, S., Scott, C., Chen, C., Dobrovolskaia, M. A., Kozlov, S. V., Prina-Mello, A., Schmid, R., Wick, P., Caputo, F., Boisseau, P., Crist, R. M., McNeil, S. E., ... Pastore, C. (2019). On the issue of transparency and reproducibility in nanomedicine. Nature Nanotechnology, 14(7), 629-635. https://doi.org/10.1038/s41565-019-0496-9

Leong, HS, Butler, KS, Brinker, CJ, Azzawi, M, Conlan, S, Dufés, C, Owen, A, Rannard, S, Scott, C, Chen, C, Dobrovolskaia, MA, Kozlov, SV, Prina-Mello, A, Schmid, R, Wick, P, Caputo, F, Boisseau, P, Crist, RM, McNeil, SE, Fadeel, B, Tran, L, Hansen, SF, Hartmann, NB, Clausen, LPW, Skjolding, LM, Baun, A, Ågerstrand, M, Gu, Z, Lamprou, DA, Hoskins, C, Huang, L, Song, W, Cao, H, Liu, X, Jandt, KD, Jiang, W, Kim, BYS, Wheeler, KE, Chetwynd, AJ, Lynch, I, Moghimi, SM, Nel, A, Xia, T, Weiss, PS, Sarmento, B, das Neves, J, Santos, HA, Santos, L, Mitragotri, S, Little, S, Peer, D, Amiji, MM, Alonso, MJ, Petri-Fink, A, Balog, S, Lee, A, Drasler, B, Rothen-Rutishauser, B, Wilhelm, S, Acar, H, Harrison, RG, Mao, C, Mukherjee, P, Ramesh, R, McNally, LR, Busatto, S, Wolfram, J, Bergese, P, Ferrari, M, Fang, RH, Zhang, L, Zheng, J, Peng, C, Du, B, Yu, M, Charron, DM, Zheng, G & Pastore, C 2019, 'On the issue of transparency and reproducibility in nanomedicine', Nature Nanotechnology, vol. 14, no. 7, pp. 629-635. https://doi.org/10.1038/s41565-019-0496-9

@article{c5b9fe1c18464e0f83ffa6a0444dac1b,

title = "On the issue of transparency and reproducibility in nanomedicine",

abstract = "Following our call to join in the discussion over the suitability of implementing a reporting checklist for bio–nano papers, the community responds.",

author = "Leong, {Hon S.} and Butler, {Kimberly S.} and Brinker, {C. Jeffrey} and May Azzawi and Steve Conlan and Christine Duf{\'e}s and Andrew Owen and Steve Rannard and Chris Scott and Chunying Chen and Dobrovolskaia, {Marina A.} and Kozlov, {Serguei V.} and Adriele Prina-Mello and Ruth Schmid and Peter Wick and Fanny Caputo and Patrick Boisseau and Crist, {Rachael M.} and McNeil, {Scott E.} and Bengt Fadeel and Lang Tran and Hansen, {Steffen Foss} and Hartmann, {Nanna B.} and Clausen, {Lauge P.W.} and Skjolding, {Lars M.} and Anders Baun and Marlene {\AA}gerstrand and Zhen Gu and Lamprou, {Dimitrios A.} and Clare Hoskins and Leaf Huang and Wantong Song and Huiliang Cao and Xuanyong Liu and Jandt, {Klaus D.} and Wen Jiang and Kim, {Betty Y.S.} and Wheeler, {Korin E.} and Chetwynd, {Andrew J.} and Iseult Lynch and Moghimi, {Seyed Moein} and Andr{\'e} Nel and Tian Xia and Weiss, {Paul S.} and Bruno Sarmento and {das Neves}, Jos{\'e} and Santos, {H{\'e}lder A.} and Luis Santos and Samir Mitragotri and Steve Little and Dan Peer and Amiji, {Mansoor M.} and Alonso, {Maria Jos{\'e}} and Alke Petri-Fink and Sandor Balog and Aaron Lee and Barbara Drasler and Barbara Rothen-Rutishauser and Stefan Wilhelm and Handan Acar and Harrison, {Roger G.} and Chuanbin Mao and Priyabrata Mukherjee and Rajagopal Ramesh and McNally, {Lacey R.} and Sara Busatto and Joy Wolfram and Paolo Bergese and Mauro Ferrari and Fang, {Ronnie H.} and Liangfang Zhang and Jie Zheng and Chuanqi Peng and Bujie Du and Mengxiao Yu and Charron, {Danielle M.} and Gang Zheng and Chiara Pastore",

note = "Funding Information: The European Nanomedicine Characterisation Laboratory (EUNCL) and the REFINE consortium effort, funded by EC-H2020, are aimed at developing a regulatory science framework for nanomedicine. EUNCL/REFINE, jointly with the National Cancer Institute{\textquoteright}s Nanotechnology Characterization Lab (NCI-NCL), are bridging the gap between publication and translation by identifying common pitfalls in nanomedicine development, defining quality attributes for pre-clinical assessment and sharing lessons learned8–11. Recognizing the value of the MIRIBEL reporting suggestions, we emphasize that each particle is unique and may have different testing requirements. It is the view of EUNCL/REFINE and NCI-NCL that the developmental path to translation should have a series of pass/fail analyses early in the process8,9. Built on our combined experiences, aspects such as sterility and endotoxin contamination, physicochemical characterization in complex biological media11, and multiparametric investigations of immuno-and cytotoxicity responses can uncover potential show-stopper toxicities12, calling for refinement of the formulation. Only then should the in vivo efficacy/safety studies commence13. Further, we support the adoption of orthogonal methodologies11, which can be highly informative with regards to the overall properties and performance of the product. Success is best achieved through a rigorous approach that is well-defined, thorough and makes use of validated assays (http://www.euncl.eu/about-us/ assay-cascade) and experimental standard operative procedures (https://ncl.cancer. gov/resources/assay-cascade-protocols) with defined quality acceptance criteria. Failure to adopt these criteria often leads to confounding results, lack of reproducibility and, ultimately, lost time and money. Supporting these minimum reporting and characterization recommendations will greatly advance nanomedicine development, which has been curtailed by the lack of comprehensive characterization data in the literature. Funding Information: Adriele Prina-Mello, Ruth Schmid, Peter Wick, Fanny Caputo, Patrick Boisseau, Rachael M. Crist and Scott E. McNeil: the view expressed in this Correspondence is reflective of the European Nanomedicine Characterisation Laboratory (EUNCL EC-H2020 ref. 654190) and the REFINE consortium (REFINE EC-H2020 ref. 761104). The work of authors Rachael M. Crist and Scott E. McNeil has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, under contract no. HHSN261200800001E. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products or organizations imply endorsement by the US government. Funding Information: Kimberly S. Butler, Hon S. Leong and C. Jeffrey Brinker: Sandia National Laboratories is a multi-mission laboratory managed and operated by National Technology and Engineering Solutions of Sandia, LLC, a wholly owned subsidiary of Honeywell International, Inc., for the US Department of Energy{\textquoteright}s National Nuclear Security Administration under contract DENA0003525. Any subjective views or opinions that might be expressed in the paper do not necessarily represent the views of the US Department of Energy or the US government. Publisher Copyright: {\textcopyright} 2019, Springer Nature Limited.",

year = "2019",

month = jul,

day = "1",

doi = "10.1038/s41565-019-0496-9",

language = "English (US)",

volume = "14",

pages = "629--635",

journal = "Nature Nanotechnology",

issn = "1748-3387",

publisher = "Nature Publishing Group",

number = "7",

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TY - JOUR

T1 - On the issue of transparency and reproducibility in nanomedicine

AU - Leong, Hon S.

AU - Butler, Kimberly S.

AU - Brinker, C. Jeffrey

AU - Azzawi, May

AU - Conlan, Steve

AU - Dufés, Christine

AU - Owen, Andrew

AU - Rannard, Steve

AU - Scott, Chris

AU - Chen, Chunying

AU - Dobrovolskaia, Marina A.

AU - Kozlov, Serguei V.

AU - Prina-Mello, Adriele

AU - Schmid, Ruth

AU - Wick, Peter

AU - Caputo, Fanny

AU - Boisseau, Patrick

AU - Crist, Rachael M.

AU - McNeil, Scott E.

AU - Fadeel, Bengt

AU - Tran, Lang

AU - Hansen, Steffen Foss

AU - Hartmann, Nanna B.

AU - Clausen, Lauge P.W.

AU - Skjolding, Lars M.

AU - Baun, Anders

AU - Ågerstrand, Marlene

AU - Gu, Zhen

AU - Lamprou, Dimitrios A.

AU - Hoskins, Clare

AU - Huang, Leaf

AU - Song, Wantong

AU - Cao, Huiliang

AU - Liu, Xuanyong

AU - Jandt, Klaus D.

AU - Jiang, Wen

AU - Kim, Betty Y.S.

AU - Wheeler, Korin E.

AU - Chetwynd, Andrew J.

AU - Lynch, Iseult

AU - Moghimi, Seyed Moein

AU - Nel, André

AU - Xia, Tian

AU - Weiss, Paul S.

AU - Sarmento, Bruno

AU - das Neves, José

AU - Santos, Hélder A.

AU - Santos, Luis

AU - Mitragotri, Samir

AU - Little, Steve

AU - Peer, Dan

AU - Amiji, Mansoor M.

AU - Alonso, Maria José

AU - Petri-Fink, Alke

AU - Balog, Sandor

AU - Lee, Aaron

AU - Drasler, Barbara

AU - Rothen-Rutishauser, Barbara

AU - Wilhelm, Stefan

AU - Acar, Handan

AU - Harrison, Roger G.

AU - Mao, Chuanbin

AU - Mukherjee, Priyabrata

AU - Ramesh, Rajagopal

AU - McNally, Lacey R.

AU - Busatto, Sara

AU - Wolfram, Joy

AU - Bergese, Paolo

AU - Ferrari, Mauro

AU - Fang, Ronnie H.

AU - Zhang, Liangfang

AU - Zheng, Jie

AU - Peng, Chuanqi

AU - Du, Bujie

AU - Yu, Mengxiao

AU - Charron, Danielle M.

AU - Zheng, Gang

AU - Pastore, Chiara

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On the issue of transparency and reproducibility in nanomedicine

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