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DANSK DSF/ISO/DIS 24190 PDF

DANSK DSF/ISO/DIS 24190 PDF

Name:
DANSK DSF/ISO/DIS 24190 PDF

Published Date:

Status:
[ Draft-Obsolete ]

Description:

Biotechnology – Analytical Methods – Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses

Publisher:
Dansk Standard

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
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$16.2
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DRAFT * W/D S/S BY DS/ISO 24190

This document provides definitions, guidelines, a framework and a risk-based approach for the design, selection and validation for methods for rapid microbial detection cellular therapeutic product manufacturing. This document contains the generalized requirements and risks associated with cellular therapeutic product manufacturing, with flexibility to address differences in specific manufacturing processes of each unique cellular therapeutic product. This document primarily addresses sterility testing in cellular therapeutic product manufacturing. This document can be applied to other cell derived therapeutic product manufacturing. This document focuses on rapid microbial test methods (RMTMs) used in both in-process and final product testing. Viral testing in cell-based therapy manufacturing is not included in this document.


Edition : 22#
File Size : 1 file , 2.1 MB
Number of Pages : 49
Product Code(s) : DSF-036, DSF-036

History

DANSK DSF/ISO/DIS 24190
DANSK DSF/ISO/DIS 24190
Published Date:
Biotechnology – Analytical Methods – Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
$16.2
DANSK DS/ISO 24190
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Biotechnology – Analytical methods – Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
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