Biotechnology — Inventory of methods for detection of microbiological contamination in mammalian cell culture

Biotechnology — Genome editing — Part 1: Vocabulary

Biotechnology — Genome editing — Part 1: Vocabulary — Amendment 1

Biotechnology — Genome editing — Part 1: Vocabulary

Biotechnology — Cell viability analytical methods — Part 1: General requirements and considerations

Biotechnology --Cell viability analytical methods — Part 2: Experimental Designs and Statistical Analysis for Evaluating the Quality of Cell Count-Based Viability Methods

Biotechnology — Requirements for RNA quantification methods for gene expression analysis of biological and bioengineered systems

Biotechnology — Gene delivery systems — Part 1: Vocabulary

Biotechnology — Gene delivery systems — Part 2: Quantification methods for viral vectors

Biotechnology — Gene delivery systems — Part 3: Guide for Methods for the Quantification and Characterization of Lipid Nanoparticles

Biotechnology — Cell counting — Part 1: General guidance on cell counting methods

Biotechnology — Cell counting — Part 1: General requirements and recommendations for cell counting analytical methods

Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance

Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR

Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR

Biotechnology — Massively parallel sequencing — Part 1: Nucleic acid and library preparation

Biotechnology — NGS — Part 1: Nucleic acid and library preparation

Biotechnology — Massively parallel sequencing — Part 2: Quality evaluation of sequencing data

Biotechnology — NGS — Part 2: Quality evaluation of sequencing data

Biotechnology — Massively parallel sequencing — Part 3: General requirements and guidance for metagenomics

Biotechnology — NGS — Part 3: General requirements and guidance for metagenomics

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

Biotechnology — Nucleic acid synthesis — Part 2: Requirements for the production and quality control of synthesized gene fragments, genes, and genomes

Biotechnology — General requirements for the measurement of ultra-low concentration samples of target nucleic acid sequence

Biotechnology – Cell characterization — Part 1: General requirements and considerations for the testing and characterization of cellular therapeutic products

Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products

Biotechnology — General requirements and considerations for cell line identification and cross-contamination testing

Biotechnology — Analytical methods — Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses

Biotechnology — Minimum requirements for optical signal measurements in photometric methods for biological samples

Biotechnology — Cellular morphological analysis — General requirements and considerations for cell morphometry to quantify cell morphological features

General requirements and considerations for cell-mediated cytotoxicity assays used in characterization and testing of CAR products for therapeutic use

General Requirements and Considerations for AAV Capsid Content Characterization for Gene Therapy

Biotechnology — Tumorigenicity testing — Part 1: General requirements and considerations for testing of cellular therapeutic products