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eLibrary > 23/30427228 DC BS ISO 20688-2. Biotechnology. Nucleic acid synthesis - Part 2. General definitions and requirements for the production and quality control of synthesized gene fragments, genes, and genomes >

23/30427228 DC BS ISO 20688-2. Biotechnology. Nucleic acid synthesis - Part 2. General definitions and requirements for the production and quality control of synthesized gene fragments, genes, and genomes, 2023

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23/30427228 DC BS ISO 20688-2. Biotechnology. Nucleic acid synthesis - Part 2. General definitions and requirements for the production and quality control of synthesized gene fragments, genes, and genomes, 2023

30427228-NC.pdf
ISO_DIS 20688-2 ed.1 - id.75852 Enquiry PDF (en).pdf [Go to Page]
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General 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
Annex€A (informative) Equipment and device list and control requirements
Annex€B (informative) Exemplary quality measurement methods
Annex€C (informative) Electrophoretogram
Annex€D (informative) Sanger sequencing
Annex€E (informative) Massively Parallel Sequencing (MPS)
Annex€F (informative) Additional quality control options for synthetic gene fragments
Annex€G (informative) The ranks of the risk posed by DNA products
Bibliography [Go to Page]

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23/30427228 DC BS ISO 20688-2. Biotechnology. Nucleic acid synthesis - Part 2. General definitions and requirements for the production and quality control of synthesized gene fragments, genes, and genomes, 2023

⨯To continue with accurate pricing,
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