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ISO 20688-1:2020 PDF — Biotechnology — Nucleic acid synthesis — Part 1: Requirements for the… — GOST Standards

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ISO 20688-1:2020

Name: ISO 20688-1:2020 — Biotechnology — Nucleic acid synthesis — Part 1: Requirements for the production and quality control of synthesized oligonucleotides
SKU: ISO 20688-1:2020
Price: 25 EUR
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Biotechnology — Nucleic acid synthesis — Part 1: Requirements for the production and quality control of synthesized oligonucleotides

Название (английский):

ISO 20688-1:2020

Biotechnology — Nucleic acid synthesis — Part 1: Requirements for the production and quality control of synthesized oligonucleotides

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 28
Дата публикации:: 19 февраля 2020 г.
Издание:: ISO IS 20688 edition 1 version 1
ICS:: 07.080

Тип поставки:

Full version25 €Ask AI2 €Read online 24h10 €Read online 72h15 €

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Цена:25 €

Описание (английский):

This document specifies minimum requirements for the production and quality control of synthesized oligonucleotides (nominally up to 250 bases). This document also describes general quality attributes for synthesized oligonucleotides as well as common methods for evaluating quality attributes.

Abstract

Overview

Key technical topics and requirements

Scope & definitions
- Applies to chemically synthesized DNA and RNA oligonucleotides (approximately 10–250 bases).
- Includes definitions for terms such as purity, reference material (RM) and certified reference material (CRM).
Design and selection
- Guidance to choose oligonucleotides fit for purpose (e.g., PCR primers, microarray probes, NGS capture probes) and use of graded quality levels (e.g., genomic vs antisense grade).
Quality management
- Producers must document processes for order receipt, production and quality control, implement a quality management system, document control and personnel training, and maintain safety controls.
Production process requirements
- Covers synthesis, purification, drying and formulation, plus process checklists and resource/equipment control.
Quality control (QC) processes
- Validation/verification of analytical methods.
- Identity verification (sequence confirmation).
- Purity assessment (e.g., HPLC or capillary electrophoresis with area normalization; OD260 measurement guidance).
- Quantity reporting (concentration and mass).
- Molar mass / base length calculations and melting temperature (Tm) assessment.
- Requirements for reporting and corrective action verification.
Additional RNA requirements
- Supplementary controls specific to synthetic oligoribonucleotides.
Informative annexes
- Process checklist, equipment list, molar mass calculations, mass analysis verification examples, CRM measurement accuracy examples, and Tm calculation methods.

Practical applications and users

Who uses ISO 20688-1:

Oligonucleotide manufacturers and custom synthesis service providers - implement consistent production and QC.
Quality control and analytical laboratories - standardize testing methods (HPLC, CE, mass spectrometry).
Biotech and pharmaceutical developers - specify required grades for primers, probes, therapeutics and starting materials.
Regulatory and compliance teams - align production practices with regional regulations and GMP when oligos are used as investigational drugs.
Research labs and core facilities - improve procurement specifications and reproducibility for PCR, NGS, microarray and gene synthesis workflows.

Related standards

Part of the ISO 20688 series prepared by ISO/TC 276 (Biotechnology). Users should consult other parts of the series and applicable regional regulations or GMP guidance when oligonucleotides are used in regulated therapeutics or clinical applications.

Keywords: ISO 20688-1, synthesized oligonucleotides, oligonucleotide quality control, HPLC, capillary electrophoresis, mass spectrometry, purity, identity, Tm, GMP, synthetic RNA.

Технические детали

Технический комитет: ISO/TC 276 - Biotechnology
SKU: ISO 20688-1:2020

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PDF

ISO 20688-1:2020

Abstract

Overview

Похожие стандарты

Key technical topics and requirements

Practical applications and users

Related standards

Технические детали

BS ISO 20688-1:2020

Biotechnology. Nucleic acid synthesis. Requirements for the production and quality control of synthesized oli…

ISO 20688-2:2024

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ISO 8212:1986

Soaps and detergents — Techniques of sampling during manufacture

ISO 20662:2020

Ships and marine technology — Hopper dredger supervisory and control systems

ISO 3021:2023

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ISO 3826-2:2008

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ISO/IEC 24730-1:2014

Information technology — Real-time locating systems (RTLS) — Part 1: Application programming interface (API)

ISO 8668-5:1992

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