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BS ISO 23033:2021

BS ISO 23033:2021

$167.15

Biotechnology. Analytical methods. General requirements and considerations for the testing and characterization of cellular therapeutic products

Published By Publication Date Number of Pages
BSI 2021 44
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This document provides general requirements for the testing of cellular therapeutic products intended for human use.

This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose.

Such considerations can be used to establish critical quality attributes for a cellular therapeutic product.

This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.

This document is not applicable to tissues used in transplantation.

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
16 4 Cellular starting materials
17 5 Design of fit for purpose analytical methods for evaluating quality attributes
5.1 General concepts
19 5.2 Approach to analytical method design
5.3 Defining quality attributes by considering components of a cellular therapeutic product
22 5.4 Design of a matrix of analytical methods
5.5 Design of a fit for purpose analytical method
23 5.6 Selection of instruments
24 5.7 Instrument qualification and maintenance
25 5.8 Managing sources of measurement variability for cell measurements
5.8.1 General
26 5.8.2 Sampling and sample preparation
27 5.8.3 Reference materials
5.8.4 Analytical reagents
28 5.9 Documentation of procedure
6 Analytical method qualification, validation and continued verification
6.1 General
6.2 Analytical method qualification
29 6.3 Analytical method validation and continued verification
6.3.1 Validation
31 6.3.2 Continued verification
6.4 Test method performance criteria
32 7 Testing of cellular therapeutic products
7.1 Considerations for specifications and release criteria for cellular therapeutic products
7.1.1 General
7.1.2 Considerations for release criteria for the final cellular therapeutic product
7.2 General requirements for the testing of the cellular therapeutic product
33 7.3 Testing to evaluate identity of a cellular therapeutic product
34 7.4 Testing to evaluate cell counts within cellular therapeutic products
7.5 Testing to evaluate viability of cells within a cellular therapeutic product
7.6 Testing to evaluate potency of a cellular therapeutic product
7.6.1 General
35 7.6.2 Importance of potency as a CQA
7.6.3 ​Assessment of potency
7.6.4 Requirements for analytical methods that evaluate potency
36 7.6.5 Design of analytical methods that evaluate potency
7.6.6 Considerations for analytical methods that evaluate potency
7.7 Testing to evaluate the purity of cellular therapeutic products
37 7.8 Testing to evaluate microbiological contamination of cellular therapeutic products
38 7.9 Testing to evaluate stability of cellular therapeutic products
39 8 Reporting
8.1 General
8.2 General requirements
40 Annex A (informative) Establishing a testing strategy for cellular therapeutic products
41 Annex B (informative) Examples of potential sources of variability in a cell analytical method
42 Bibliography

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BS ISO 23033:2021
$167.15