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BS ISO 20688-2:2024

BS ISO 20688-2:2024

$167.15

Biotechnology. Nucleic acid synthesis – Requirements for the production and quality control of synthesized gene fragments, genes, and genomes

Published By Publication Date Number of Pages
BSI 2024 38
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 Requirements for quality management
4.1 General requirements
12 4.2 Control of documents
13 4.3 Quality management system
4.4 Biorisk management and safety control
5 Requirements for resource management
5.1 Facilities and environmental condition
5.2 Equipment and instruments
14 5.3 Raw materials
5.4 Personnel
6 Biosafety and biosecurity requirements
6.1 General
6.2 DNA sequence screening mechanism
15 7 Requirements for quality control in production
7.1 General
7.2 Quality control in synthetic gene fragments production
7.2.1 General
7.2.2 Sequence design
16 7.2.3 Assembly
7.2.4 Purification
7.2.5 Product preservation
7.3 Quality control in synthetic gene production
7.3.1 General
7.3.2 Colony screening
7.3.3 DNA preparation from the host cell
17 7.3.4 Sequence verification
7.3.5 Product preservation
7.4 Quality control in synthetic genome production
7.4.1 General
7.4.2 Assembly
7.4.3 Sequence verification
18 8 Requirements for product quality
8.1 Synthetic gene fragments
8.1.1 General
8.1.2 Yield
8.1.3 Purity
8.1.4 Size
8.1.5 Gene cloning accuracy
8.2 Synthetic genes
8.2.1 General
8.2.2 Yield
19 8.2.3 Purity
8.2.4 Sequence
8.2.5 Integrity
8.2.6 Residual impurities analysis
20 8.2.7 Supercoiled plasmid
8.2.8 Bioburden
8.2.9 Specific quality indicators for synthetic DNA libraries
8.3 Synthetic genome
8.3.1 General
8.3.2 Sequence
21 9 Delivered/synthesized material specifications
9.1 Main information
9.2 Other information
22 Annex A (informative) Example equipment and device list and their control requirements
24 Annex B (informative) Exemplary quality measurement methods
26 Annex C (informative) Electrophoretogram
30 Annex D (informative) Sanger sequencing
31 Annex E (informative) Massively parallel sequencing
34 Annex F (informative) Additional quality control options for synthetic gene fragments
36 Annex G (informative) Example ranking of the risk posed by DNA products
37 Bibliography

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BS ISO 20688-2:2024
$167.15