ISO/TC 276 - Biotechnology

This document specifies requirements for the biobanking of deep-sea biological material including the collection, processing, transportation and storage of deep-sea biological material. This document is applicable only to deep-sea biological material that can be used for biomolecular processing, e.g. nucleic acids, proteins, and metabolites. This document is applicable to all organizations performing research and development on deep-sea biological material. This document does not apply to the collection of deep-sea biological material intended for environmental impact assessment for sea floor mining. NOTE International, national or regional regulations or requirements or a multiple of these can also apply to specific topics covered in this document.

This document specifies requirements for primary containers intended for the storage of biological materials in biobanks. In addition to general requirements, this document also specifies special requirements depending on the storage conditions, the biological material and the intended use, as well as requirements for documentation and quality control. These requirements establish the framework for ensuring that primary containers meet the necessary quality criteria. This document specifies test criteria and test methods that enable proof of conformity with the requirements. This document is primarily aimed at manufacturers that produce primary containers for the storage of biological materials. Biobanks, submitters and users of biological material, and organizations that monitor or control the work of biobanks can also use this document. NOTE For primary containers intended for biological material for therapeutic use, other requirements can apply.

This document specifies general requirements and guidance for metagenomics-dedicated sample preparation, and generating and analysing metagenomics sequence data obtained from massive parallel sequencing platforms. The specified metagenomics process includes the following stages: a) sampling strategy and process, including type, storage, transportation, extraction, quality; b) nucleic acid library preparation c) design and review process including sequencing strategy and assessment; d) database construction; e) bioinformatics analysis and report f) validation and verification for bioinformatics pipeline, and database This document applies to laboratories and research organizations.

This document provides an inventory of methods for the detection of microbiological contamination in mammalian cell culture. This document includes considerations for the selection of methods to test the presence of common contaminants such as bacteria, fungi, viruses and mycoplasma. This document is not applicable to prions and protists. This document is intended for use by biomedical researchers, biobank operators and others performing mammalian cell culture.

This document specifies requirements for the biobanking of human neural stem cells (hPSC-NSCs) derived from human pluripotent stem cells (hPSCs), including the requirements for the differentiaton, culture, characterization, quality control (QC), storage, thawing and transport of hPSC-NSCs. Requirements for the collection of biological source material, the transport to and reception of biological source material and hPSCs at the biobank, as well as the establishment, expansion and QC of hPSCs are covered in ISO 24603. This document is applicable to all organizations performing biobanking of hPSC-NSCs used for research and development in the life sciences. This document does not apply to hPSC-NSCs for the purpose of in vivo application in humans, clinical applications or therapeutic use. NOTE International, national or regional regulations or requirements or multiple of them can also apply to specific topics covered in this document.

This document describes a practical procedure for nucleotide sequence database evaluation and validation. This document describes minimum requirements for the validation of a nucleotide sequence database. This document is applicable only for databases consisting of entries of nucleotide sequences. This document is not applicable to the general evaluation of the entire database quality including the quality of each data entry. EXAMPLE The use of the validated database is for confirming a representative sequence specificity including primers or probes for qualification and quantification of target nucleic acids by conventional polymerase chain reaction (PCR), quantitative polymerase chain reaction (qPCR), digital polymerase chain reaction (dPCR) and microarray technologies.

This document provides general requirements for cell morphometry to quantify cell morphological features including cell shape, size and texture. This document addresses aspects of cell image capture using optical microscopy and image processing for morphometry. This document does not address the statistics associated with a morphological analysis of a cellular sample. This document also gives terms and definitions corresponding to cell morphological descriptors, and lists examples and their formulae, that represent quantitative cellular morphological features for evaluation of cell morphology in cell analysis. This document primarily applies to morphological analysis of cultured mammalian cells. This document is not intended for imaging used in clinical diagnostics.

This document specifies a framework for data interoperability of data systems, such as databases, data management systems, web interfaces, API, etc. that manage stem cell data. It is applicable to all human stem cell types. This document does not apply to other animal stem cells or plant stem cells. This document specifies considerations and requirements of stem cell data for data interoperability, such as cell characteristics, applied technologies, ethical requirements, and data sharing, analysis, and accessibility. This document describes an interoperable framework for stem cell data, which can be used for existing systems or existing architectures. The intended audiences for this document are data generators, implementors of IT infrastructure to handle the data, data providers and data consumers.

This document provides requirements for the biobanking of helminths as parasitic resources including the collection, safeguarding, classification, proliferation, preservation, storage and distribution of helminths. This document sets requirements for the quality of helminths and their associated data, the data collection, and safety management when handling the helminths as a source of human disease infection. This document is applicable to all organizations performing biobanking with helminths used for research and development. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

This document specifies the requirements for the production and quality control of synthesized double-stranded DNA. It describes requirements for quality management, resource management, biosafety and biosecurity, quality control in production, product quality, and delivered product specifications for synthesized gene fragments, genes and genomes. This document is applicable to synthetic gene fragments, genes and genomes with a length below 10 Mbp (base pairs) in the forms of non-clonal fragments (linear) and clonal genes in plasmids (circular). This document does not provide specific requirements for materials used solely for diagnostic purposes. When the synthesized nucleic acids are procured and used for diagnostic purposes, the user can take ISO 15189, ISO 13485 and other related clinical standards into account.

This document specifies minimum requirements to support accurate measurement of optical signals in photometric methods used for qualitative or quantitative characterization of biological samples. This document is applicable to optical signals that are generated, for example, by bioluminescence, chemiluminescence and fluorescence, and optical signals that are detected as changes of light due to absorption. This document addresses the verification of optical signal measurement instruments used in photometric methods for measurement of biological samples including considerations for the use of optical references. This document does not provide sector- or application-specific performance criteria for the workflow of measuring biological samples. When applicable, users can also consult existing sector- or application- specific standards, or both.

This document specifies requirements and recommendations for the design, development and establishment of predictive computational models for research purposes in the field of personalized medicine. It addresses the set-up, formatting, validation, simulation, storing and sharing of computational models used for personalized medicine. Requirements and recommendations for data used to construct or required for validating such models are also addressed. This includes rules for formatting, descriptions, annotations, interoperability, integration, access and provenance of such data. This document does not apply to computational models used for clinical, diagnostic or therapeutic purposes.

This document provides guidance, a framework and a risk-based approach for the selection and validation of methods for rapid microbial detection in cellular therapeutic product manufacturing. This document provides a flexible risk-based framework for the detection of microbial contamination in cellular therapeutic products and cellular intermediates. This document provides general requirements and risks associated with cellular therapeutic product manufacturing, with flexibility to address differences in specific manufacturing processes of each unique cellular therapeutic product. This document primarily addresses sterility testing in cellular therapeutic product manufacturing. This document is applicable to other cell-derived therapeutic product manufacturing. This document focuses on rapid microbial test methods (RMTMs) used for both in-process and final product testing. Viral testing in cellular therapeutic product manufacturing is not included in this document.

This document illustrates the workflow of shotgun metagenomic sequence data processing of host-derived microbiome and environmental metagenomes. This document specifies the requirements for quality control of shotgun metagenomic sequence data processing for massively parallel DNA sequencing. This document provides guidelines for data directory, data archive and metadata for shotgun metagenomic sequence data. This document applies to data storage, sharing and interoperability of shotgun metagenomic sequence data. This document applies to shotgun metagenomic sequence data processing and analyses, but excludes functional analysis.

This document defines terms related to cell line authentication in the field of biotechnology. It describes the general principles, detection strategies and analytical methods for cell line authentication. It specifies requirements and key considerations for method selection, quality control parameters, data analysis and reporting. This document is applicable to routine inspection of cell lines in culture and in storage in the fields of basic research, translational studies and product manufacturing. It is also applicable to cell line origin validation in academic and industrial laboratories, cell banks and manufacturing sites. It is primarily applicable to mammalian cells, including human cells. This document does not apply to non-animal cells (e.g. microbial contamination, plant cells), nor to cells in complex matrices (e.g. tissues, organs, organoids, plants).

This document specifies general requirements and considerations for the design of packaging used to contain cells for therapeutic use. This document is applicable to packaging intended to contain the final products of cells for therapeutic use, as well as their starting and intermediate materials. This document does not apply to: a) receptacles used for processing cells in manufacturing processes, e.g. cell culture flask or bag; b) shipping containers containing packages for transportation; c) services that utilize packages, e.g. storage services. NOTE 1 Examples of packaging, packages and shipping containers are illustrated in Annex A. NOTE 2 The design of packaging includes processes to ensure that the designed packaging is manufactured to a required specification through trial manufacturing, testing and implementation of quality management. NOTE 3 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

This document specifies a general concept for a provenance information model for biological material and data and requirements for provenance data interoperability and serialization. The provenance information model covers any information relevant to the quality and fitness for purpose of the biological material generated throughout the preanalytical phase of the materials life cycle from collection to analysis, data originating from analytical procedures applied to the biological material and results from further mathematical processing of the data. This document is applicable to organizations, authorities and industries that are: a) collecting, processing or distributing biological material for research; b) generating, collecting, analysing or storing data on biological material. This document does not apply to biological material and data used for other than research or in fields that are regulated by national, regional or international laws, such as medical diagnosis and therapy or food production. NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

This document specifies requirements and gives guidance to suppliers and users of ancillary materials (AMs) to improve the consistency and quality of AMs of biological (human and animal) and chemical origin used in the production of cellular therapeutic products and gene therapy products for human use. This document is applicable to materials that are used for cell processing and that come into contact with the active substance and that do not intentionally form part of the final cell and gene therapy product. EXAMPLE 1 Reagents, anticoagulants, cytokines, growth factors, enzymes, antibodies, serum (human or bovine), buffered solutions, culture media, dishes (coated with biological material), beads (coated with biological material), cryoprotectants (agents for cryopreservation), activation agents/reagents, non-mammalian cell (e.g. insect cell, bacterial cell), plasmid, viral vector. This document does not apply to materials that are not used for cell processing, materials that do not come into contact with the active substance, or materials that intentionally form part of the final cell and gene therapy product. EXAMPLE 2 Cells that are either starting materials, intermediates or final form of a cellular therapeutic product, feeder cells, additives used post bioprocessing, scaffolds, non-biological consumables (e.g. beads, dishes, tissue culture flasks, bags, tubing, pipettes, needles), other plasticware that come into contact with the cell or tissue, apparatus, instruments. A decision flowchart is given in Annex A. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.

This document specifies requirements for the consistent formatting and documentation of data and corresponding metadata (i.e. data describing the data and its context) in the life sciences, including biotechnology, and biomedical, as well as non-human biological research and development. It provides guidance on rendering data in the life sciences findable, accessible, interoperable and reusable (F-A-I-R). This document is applicable to manual or computational workflows that systematically capture, record or integrate data and corresponding metadata in the life sciences for other purposes. This document provides formatting requirements for both primary experimental or procedural data obtained manually and machine derived data. This document also describes requirements for storing, sharing, accessing, interoperability and reuse of data and corresponding metadata in the life sciences. This document specifies requirements for large quantities of data systematically obtained from automated high throughput workflows in the life sciences, as well as requirements for large-scale and small-scale data sets obtained by other life science technologies and manual data capture. This document is applicable to many domains in biotechnology and the life sciences including, but not limited to: basic/applied research in all domains of the life sciences, and industrial, medical, agricultural, or environmental biotechnology (excluding for diagnostic or therapeutic purposes), as well as methodology-driven domains, such as genomics (including massive parallel sequencing, metagenomics, epigenomics and functional genomics), transcriptomics, translatomics, proteomics, metabolomics, lipidomics, glycomics, enzymology, immunochemistry, synthetic biology, systems biology, systems medicine and related fields.

This document specifies requirements for the biobanking of human and mouse pluripotent stem cells (PSCs), including the collection of biological source material and associated data, establishment, expansion, characterization, quality control (QC), maintenance, preservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking with human and mouse PSCs used for research and development. This document does not apply to cell lines used for in vivo application in humans, clinical applications or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from bone marrow (hBM-MSCs), including the collection of bone marrow and associated data, isolation, culture, characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking with hBM-MSCs used for research. This document does not apply to hBM-MSCs for the purpose of in vivo application in humans, cell therapy, clinical applications, tissue engineering or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

This document specifies requirements for the biobanking of bacteria and archaea. It includes management of microbial material associated data as well as biosafety and biosecurity requirements. This document is applicable to all organizations performing biobanking with bacteria and archaea used for research and development. This document does not apply to processing methods for microbial materials intended for food/feed production, laboratories undertaking food/feed analysis or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from umbilical cord tissue (i.e. Wharton’s jelly), further referred to as hUC-MSCs, including the collection of umbilical cord tissue and associated data, isolation, culture characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking of hUC-MSCs used for research and development. This document does not apply to hUC-MSCs for the purpose of in vivo application in humans, clinical applications or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

This document specifies the general requirements for and gives guidance on quality assessments of nucleic acid samples. It specifies general guidelines for library preparations and library quality assessments prior to sequencing and data generation.

This document specifies requirements for the collection, reception, preparation, preservation, transport, storage, distribution, destruction and disposal of biological materials obtained from animals, excluding humans. Such resources include solid tissues, fluid samples and associated cells, excretory products and associated data. This document is applicable to biological material or associated data, or both, that can be used for research and development and to biomolecules derived from the biological material, e.g. nucleic acids, proteins and metabolites. This document is applicable to all organizations performing biobanking for research and development. This document does not apply to biological material intended for food or feed production, laboratories undertaking analysis for food or feed production, or therapeutic use, or multiple of them. This document does not apply to the establishment of cell lines derived from animal biological material. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

This document defines terms related to genome editing technology. This document is applicable to general use of genome editing across species.

This document specifies requirements for the collection, preparation, preservation, transportation, storage, distribution and disposal of plant biological materials and associated data. This document is applicable only to biological material that can be used for further processing of biomolecules, e.g. nucleic acids, proteins and metabolites. This document is applicable to all organizations performing plant biobanking for research and development.

This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables, used in the manufacturing of cells for therapeutic use. This includes equipment for processing cells for therapeutic use starting from cell isolation/selection, expansion, washing and volume reduction, from cell finish through to cryopreservation for the storage of cells for therapeutic use. This document gives guidance on the design, use and maintenance of equipment and equipment systems to both suppliers and users from aspects including the target parties, i.e. supplier or user, and phase of involved task, i.e. design, use or maintenance. This document is applicable to any unit operation system that is used, alone or in combination, for the manufacturing of cells for therapeutic use, meeting user requirements. It is applicable to devices used for the purpose of monitoring equipment status. It does not apply to: processing equipment for cells for therapeutic use used at the point of care; devices used for analytical purposes; biosafety cabinets, general cell culture equipment (such as CO2 incubators, etc.), and software to control multiple equipment systems or multiple unit operations.

This document provides general requirements for the testing of cellular therapeutic products intended for human use. This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose. Such considerations can be used to establish critical quality attributes for a cellular therapeutic product. This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products. This document is not applicable to tissues used in transplantation.

This document reviews best practices that: a) respect the existing standardization efforts of life sciences research communities; b) normalize key aspects of data description particularly at the level of the biology being studied (and shared) across the life sciences communities; c) ensure that data are “findable” and useable by other researchers; and d) provide guidance and metrics for assessing the applicability of a particular data sharing plan. This document is applicable to domains in life sciences including biotechnology, genomics (including massively parallel nucleotide sequencing, metagenomics, epigenomics and functional genomics), transcriptomics, translatomics, proteomics, metabolomics, lipidomics, glycomics, enzymology, immunochemistry, life science imaging, synthetic biology, systems biology, systems medicine and related fields.

This document specifies general requirements and recommendations for quality assessments and control of massively parallel sequencing (MPS) data. It covers post raw data generation procedures, sequencing alignments, and variant calling. This document also gives general guidelines for validation and documentation of MPS data. This document does not apply to any processes related to de novo assembly.

This document specifies process and quality requirements for the biobanking of mammalian (including human) cell lines. It describes requirements for the fundamental procedures of the biobank handling cell lines, such as establishment, reception, identification, propagation, preservation, storage, quality control, and distribution of cell lines. This document can be used by organizations performing biobanking activities with mammalian cell lines used for research and development, biobank users, organizations and schemes using peer-assessment and accreditation bodies. This document does not apply to biological material intended for therapeutic use. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

This document specifies requirements for data management and publication in microbial resource centres (MRCs) to enable consistent formatting, and a quality control workflow to improve the overall quality of data. It also provides recommendations for MRCs to improve data sharing and integration of microbial material and associated data. This document is intended to facilitate procedures such as accessioning, acquisition, authentication, preservation, storage, and distribution, and can be used by MRCs, regulatory authorities, organizations, and schemes using peer-assessment to confirm or recognize the competence of MRCs in data management and publication NOTE International, national and/or regional regulations or requirements can also apply to specific topics covered in this document.

This document specifies general requirements and reviews the points to consider for the transportation of cells for therapeutic use, including storage during transportation. Transportation starts from the transfer of the packaged cells by the sender to the transportation service provider and ends when the package is delivered to the receiver at its destination. This document does not apply to transportation of cells within one facility. This document includes the development of a transportation plan including verification and validation, communication between the client and the transportation service provider, and associated documentation. This document does not specify particular conditions for transportation such as specification for shipping container, ambient temperature control, etc.

This document specifies the validation and verification requirements applicable to a biobank to be able to demonstrate that it operates its processing of biological materials with validated and/or verified methods that are fit for purpose. This document is intended for use in the implementation and validation of processing methods for biological materials. This document covers method validation and verification for the production of all biological materials. This document does not apply to biological material intended for food/feed production, laboratories undertaking food/feed analysis, and/or therapeutic use. Reference material production is not covered in this document. For the production requirements for reference materials, see ISO 17034.

This document provides guidance to biobanks on how to implement the quality management, management, and technical requirements of ISO 20387. It expands on aspects of ISO 20387 and provides examples for illustration purposes. The aim of this document is to assist biobanks to address competency of personnel and appropriate quality of biological material and data collections. This document is equally applicable to newly established and existing biobanks. This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g., human, animal, fungus and plant) and microorganisms for research and development. This document does not apply to biological material intended for feed/food production, laboratories undertaking analysis for food/feed production and/or therapeutic use.

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.

This document provides a method for evaluating aspects of the quality of a cell counting measurement process for a specific cell preparation through a set of quality indicators derived from a dilution series experimental design and statistical analysis. The quality indicators are based on repeatability of the measurement and the degree to which the results conform to an ideal proportional response to dilution. This method is applicable to total, differential, direct and indirect cell counting measurement processes, provided that the measurement process meets the criteria of the experimental design (e.g. cells are suspended in a solution). This method is most suitable during cell counting method development, optimization, validation, evaluation and/or verification of cell counting measurement processes. This method is especially applicable in cases where an appropriate reference material to assess accuracy is not readily available. This method does not directly provide the accuracy of the cell count. This method is primarily applicable to eukaryotic cells. NOTE Several sector/application specific international and national standards for cell counting exist. Where applicable, consulting existing standards when operating within their scope can be helpful.

This document provides generic requirements for evaluating the performance and ensuring the quality of methods used for the quantification of specific nucleic acid sequences (targets). This document is applicable to the quantification of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) target sequences using either digital (dPCR) or quantitative real-time PCR (qPCR) amplification technologies. It applies to target sequences present in nucleic acid molecules including double-stranded DNA (dsDNA) such as genomic DNA (gDNA) and plasmid DNA, single stranded DNA (ssDNA), complementary DNA (cDNA), and single stranded RNA (ssRNA) including ribosomal RNA (rRNA), messenger RNA (mRNA), and long and short non-coding RNA [microRNAs (miRNAs) and short interfering RNAs (siRNAs)], as well as double-stranded RNA (dsRNA). This document applies to nucleic acids derived from biological sources such as viruses, prokaryotic and eukaryotic cells, cell-free biological fluids (e.g. plasma or cell media) or in vitro sources [e.g. oligonucleotides, synthetic gene constructs and in vitro transcribed (IVT) RNA]. This document is not applicable to quantification of very short DNA oligonucleotides ( This document covers: — analytical design including quantification strategies (nucleic acid copy number quantification using a calibration curve as in qPCR or through molecular counting as in dPCR, quantification relative to an independent sample and ratio measurements) and use of controls; — quantification of total nucleic acid mass concentration and quality control of a nucleic acid sample including assessment of nucleic acid quality (purity and integrity); — PCR assay design, optimization, in silico and in vitro specificity testing; — data quality control and analysis including acceptance criteria, threshold setting and normalization; — method validation (precision, linearity, limit of quantification, limit of detection, trueness and robustness) with specific requirements for qPCR and dPCR; — approaches to establishing metrological traceability and estimating measurement uncertainty. This document does not provide requirements or acceptance criteria for the sampling of biological materials or processing of biological samples (i.e. collection, preservation, transportation, storage, treatment and nucleic acid extraction). Nor does it provide requirements and acceptance criteria for specific applications (e.g. food or clinical applications where specific matrix issues can arise).

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality. This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development. Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks. This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use. NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document. NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.

ISO 20391-1:2018 defines terms related to cell counting for biotechnology. It describes counting of cells in suspension (generally cell concentration) and cells adhered to a substrate (generally area density of cells). It provides key considerations for general counting methods (including total and differential counting, and direct and indirect counting) as well as for method selection, measurement process, and data analysis and reporting. ISO 20391-1:2018 is applicable to the counting of all cell types ? mammalian and non-mammalian (e.g. bacteria, yeast) cells. ISO 20391-1:2018 is not intended for counting of cells while in a tissue section or a biomaterial matrix. Several sector/application-specific international and national standards for cell counting currently exist. When applicable, the user can consult existing standards when operating within their scope (specific measurement techniques and/or applications).

This document defines terms related to gene delivery systems. This document is applicable to the general use of gene delivery systems across species and for all applications.

This document provides minimum requirements for quantifying viral vectors in term of physical titer and functional titer. It provides key considerations for general methods for viral vector quantification as well as for method selection, measurement process, data analysis, and reporting. This document is applicable to all types of viral vectors (e.g., adeno-associated, adenovirus, retrovirus, lentivirus, herpesvirus) for therapeutic use, including their research and development. This document is not intended for viral vectors for non-health sectors.

This document describes the minimum requirements for bacteriophage preparation processing including the assessment of the titer and quality control. This document applies to data processing of bacteriophage isolation, culture, purification and storage. This document applies to the quality evaluation/assessment of bacteriophage used for therapy.

This document specifies requirements for the biobanking of human natural killer (NK) cells derived from human pluripotent stem cells (hPSCs), including the requirements for the differentiaton, culture, characterization, quality control, storage, thawing and transport of NK cells. Requirements for the collection of biological source material, the transport to and reception of biological source material and hPSCs at the biobank, as well as the establishment, expansion and QC of hPSCs are covered in ISO 24603. This document is applicable to all organizations performing biobanking of human NK cells used for research and development in the life sciences. This document does not apply to human NK cells for the purpose of in vivo application in humans, clinical applications or therapeutic use. NOTE International, national or regional regulations or requirements or multiple of them can also apply to specific topics covered in this document.

This document specifies the key characteristics of stem cell data for data interoperability of stem cell data systems, which includes, several biological characteristics, safety, stability, efficacy, etc. This document can be used by stem cell database developers, stem cell data/system users, those who are generating, sending, receiving or sharing stem cell data, as well as information technology specialists focussing on system design or maintenance.

This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well as the accompanying documentation. This document is applicable to cellular therapeutic products, including gene therapy products whereby cells form part of the final product. It does not apply to products without cells. The AMs described in this document include those of biological origin [e.g. sera, media (including media additives), growth factors, and monoclonal antibodies] and chemical origin. This document does not address dimethyl sulfoxide (DMSO) for cryopreservation, beads, scaffolds, feeder cells, apparatus and instruments, or additives used post bioprocessing. This document does not cover the selection, assessment or control of starting materials and excipients. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.

This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products. This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells. This document does not cover the selection, assessment or control of starting materials and excipients. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.