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eLibrary > BS ISO 20688-2:2024 Biotechnology. Nucleic acid synthesis - Requirements for the production and quality control of synthesized gene fragments, genes, and genomes >

BS ISO 20688-2:2024 Biotechnology. Nucleic acid synthesis - Requirements for the production and quality control of synthesized gene fragments, genes, and genomes, 2024

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

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