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BS ISO 23033:2021 Biotechnology. Analytical methods. General requirements and considerations for the testing and characterization of cellular therapeutic products >
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BS ISO 23033:2021 Biotechnology. Analytical methods. General requirements and considerations for the testing and characterization of cellular therapeutic products, 2021
- National foreword
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Cellular starting materials
- 5 Design of fit for purpose analytical methods for evaluating quality attributes [Go to Page]
- 6 Analytical method qualification, validation and continued verification [Go to Page]
- 7 Testing of cellular therapeutic products [Go to Page]
- 8 Reporting [Go to Page]
- Annex A (informative) Establishing a testing strategy for cellular therapeutic products
- Annex B (informative) Examples of potential sources of variability in a cell analytical method
- Bibliography [Go to Page]