Toward an international standardisation roadmap for nanomedicine

被引：4

作者：

Caputo, Fanny ^{[1
,12
]}

Favre, Georges ^{[1
,12
]}

Borchard, Gerrit ^{[2
]}

Calzolai, Luigi ^{[3
]}

Fisicaro, Paola ^{[1
]}

Frejafon, Emeric ^{[4
]}

Guenday-Tuereli, Nazende ^{[5
]}

Koltsov, Denis ^{[6
]}

Minelli, Caterina ^{[7
]}

Nelson, Bryant C. ^{[8
]}

Parot, Jeremie ^{[9
]}

Prina-Mello, Adriele ^{[10
]}

Zou, Shan ^{[11
]}

Ouf, Francois-Xavier ^{[1
,12
]}

机构：

[1] Lab Natl Metrol & Essais LNE, ZA Trappes Elancourt,29 Rue Roger Hennequin, F-78190 Trappes, France

[2] Univ Geneva, Inst Pharmaceut Sci Western Switzerland ISPSO, Sch Pharmaceut Sci, Geneva, Switzerland

[3] European Commiss Joint Res Ctr JRC, Ispra, Italy

[4] BRGMFr Serv Geol Natl, F-45100 Orleans, France

[5] MyBiotech GmbH, Ind Str 1B, D-66802 Uberherrn, Germany

[6] BREC Solut, 54B Turzyn, PL-07221 Turzyn, Poland

[7] Natl Phys Lab, Hampton Rd, Teddington TW11 0LW, England

[8] NIST, Mat Measurement Lab, Gaithersburg, MD USA

[9] SINTEF Ind, Biotechnol & Nanomed Dept, Trondheim, Norway

[10] Trinity Coll Dublin, Trinity Translat Med Inst, Sch Med, Lab Biol Characterizat Adv Mat LBCAM, Dublin, Ireland

[11] Natl Res Council Canada, Metrol Res Ctr, Ottawa, ON K1A 0R6, Canada

[12] LNE, NanoMesureFrance, 1 Rue Gaston Boissier Paris, F-75724 Paris 15, France

来源：

DRUG DELIVERY AND TRANSLATIONAL RESEARCH | 2024年 / 14卷 / 09期

关键词：

Nanomedicine; Workshop; Regulatory science; Standardisation; Education; GMP; PRODUCTS;

D O I：

10.1007/s13346-024-01646-2

中图分类号：

TH7 [仪器、仪表];

学科分类号：

0804 ; 080401 ; 081102 ;

摘要：

The French National Metrology Institute (LNE) initiated a series of events to identify priorities for test methods and their harmonisation that directly address regulatory needs in Nanomedicine. One of these workshops entitled "The International Standardisation Roadmap for Nanomedicine" held in October 2023 (Paris, France) brought together key experts in the characterisation of nanomedicines and medical products containing nanomaterials, including the Joint Research Centre of the European Commission, SINTEF Industry and the metrology institutes of France, the UK, the USA and Canada, two flagship initiatives of the European Commission (PHOENIX and SAFE-n-MEDTECH Open Innovation Test Beds), representatives of a working party on mRNA vaccines at the European Directorate for the Quality of Medicines (EDQM) and members of international standardisation and pre-normative organisations (including CEN, ISO, ASTM, VAMAS). Two take-home message came out from the discussion. First, developing standard test methods and Reference Materials (RMs) for nanomedicines is a key priority for the European Commission and various stakeholders. Furthermore, there was a unanimous recognition of the need for a unified approach between standardisation committees, regulators and the nanomedicine community. At the USA, Canadian and European level, examples of success stories and of future initiative have been discussed. Future perspectives include the creation of a dedicated Working Group under CEN/TC 352 to consolidate efforts and develop a nanomedicine standardisation roadmap.

引用

页码：2578 / 2588

页数：11

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