BS ISO 20688-1:2020
生物技术核酸合成合成寡核苷酸的生产和质量控制要求

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适用范围: What is ISO 20688 ‑ 1 about? ISO 20688 discusses nucleic acid synthesis in biotechnology. ISO 20688 ‑ 1 outlines minimum requirements for the production and quality control of synthesized oligonucleotides (nominally up to 250 bases). ISO 20688 ‑ 1 also describes general quality attributes for synthesized oligonucleotides as well as common methods for evaluating quality attributes. Control of quality in production is important in the synthesis of oligonucleotides. The quantification of the size range, concentration, and contaminants is necessary to ensure that quality requirements are met for end-use applications. Who is ISO 20688 ‑ 1 for? ISO 20688 ‑ 1 on production and quality control of synthesized oligonucleotides is useful for: Manufacturers of synthesized oligonucleotides Biotechnology laboratories for synthesized oligonucleotides Regulatory authorities Why should you use ISO 20688 ‑ 1 ? Single-stranded, linear bio-polymers made up of nucleotides which are called “synthetic oligonucleotides” or ‘oligos’ are indispensable components for biotechnology. They are used as polymerase chain reaction (PCR) amplification primers, microarray, real-time PCR or next-generation sequencing (NGS) capture probes, and as input starting materials for the creation of entire target genes. ISO 20688 ‑ 1 guideline provides general quality management requirements, resource management, production process, quality control process, and additional req...

BS ISO 20688-1:2020生物技术 核酸合成 合成寡核苷酸的生产和质量控制要求