Abstract Preview

This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products.

This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.

This document does not cover the selection, assessment or control of starting materials and excipients.

NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.


General information

  • Status :  Published
    Publication date : 2018-11
  • Edition : 1
    Number of pages : 10
  • :
    ISO/TC 276
    Biotechnology
  • 07.080
    Biology. Botany. Zoology

Buy this standard

Format Language
PDF + ePub
Paper
  • CHF58

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information