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BSI 23/30427228 DC 2023

BSI 23/30427228 DC 2023

$13.70

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

Published By Publication Date Number of Pages
BSI 2023 36
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PDF Catalog

PDF Pages PDF Title
1 30427228-NC.pdf
3 ISO_DIS 20688-2 ed.1 – id.75852 Enquiry PDF (en).pdf
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
12 4 General requirements for quality management
4.1 General requirements
4.2 Control of documents
13 4.3 Quality management system
4.4 Biorisk management and safety control
14 5 Requirements for resource management
5.1 Facilities and environmental condition
5.2 Equipment and instruments
5.3 Raw materials
15 5.4 Personnel
6 Biosafety and biosecurity requirements
6.1 General
6.2 DNA sequence screening mechanism
7 Requirements for quality control in production
7.1 General
16 7.2 Quality control in synthetic gene fragments production
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
7.3.1 General
17 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
7.4.1 General
18 7.4.2 Assembly
7.4.3 Sequence verification
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
19 8.1.5 Gene cloning accuracy
8.2 Synthetic genes
8.2.1 General
8.2.2 Yield
8.2.3 Purity
8.2.4 Sequence
8.2.5 Integrity
20 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
21 8.3 Synthetic genome
8.3.1 General
8.3.2 sequence
9 Delivered/Synthesized Material Specifications
22 Annex€A (informative) Equipment and device list and control requirements
24 Annex€B (informative) Exemplary quality measurement methods
26 Annex€C (informative) Electrophoretogram
29 Annex€D (informative) Sanger sequencing
30 Annex€E (informative) Massively Parallel Sequencing (MPS)
33 Annex€F (informative) Additional quality control options for synthetic gene fragments
34 Annex€G (informative) The ranks of the risk posed by DNA products
35 Bibliography

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BSI 23/30427228 DC 2023
$13.70