ISO INTERNATIONAL STANDARD 23033 First edition 2021-08 Biotechnology — Analytical methods General requirements and considerations for the testing and characterization of cellular therapeutic products Biotechnologie Méthodes analytiques Exigences et considérations genérales pour les essais et la caracterisation de produits de thérapie cellulaire Reference number IS0 23033:2021(E) ISO IS02021 IS0 23033:2021(E) COPYRIGHTPROTECTED DOCUMENT IS02021 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either Iso at the address below or Iso's member body in the country of the requester. IsO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2021 - All rights reserved