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Implementing global norms in the biotechnology sector

The biotechnology sector is essential to advancing knowledge, enhancing healthcare, and promoting global economic growth.

The importance of ensuring the moral, ethical, and technical standards of biotechnological products and processes grows as this field continues to advance at an unprecedented rate.

For the biotechnology sector to harmonize practices, encourage innovation, and address new challenges globally, international standards must be implemented.

The significance of international standards in biotechnology, as well as their advantages and implementation difficulties, are discussed in this article.

Biotechnology — Massive parallel DNA sequencing — General specifications for shotgun metagenomic sequence data processing

ISO/TS 24420:2023

A wide range of fields are included in biotechnology, such as genetic engineering, drug development, agriculture, and environmental management.

International standards offer a universal framework that promotes cross-border cooperation, interoperability, and information exchange.

For the purpose of developing and regulating biotechnological products and processes, they serve as a resource for researchers, decision-makers, and industry stakeholders.

ISO/TS 24420:2023 is one of the standards that mentions this section.

The workflow for shotgun metagenomic sequence data processing of host-derived microbiomes and environmental metagenomes is shown in this document.

In order to process shotgun metagenomic sequence data for massively parallel DNA sequencing, this document lays out the requirements for quality control.

For shotgun metagenomic sequence data, this document offers guidelines for the data directory, data archive, and metadata.

Shotgun metagenomic sequence data storage, sharing, and interoperability are covered by this document.

The functional analysis of metagenomic shotgun sequence data is not covered in this document.

To guarantee that biotechnological products are secure for users, patients, and the environment, international standards establish strict safety and quality protocols. They support risk assessment, risk management, and hazard analysis by offering guidelines and assisting in identifying potential risks.

Biotechnology businesses can boost consumer trust and instill confidence in their products by adhering to these standards.

Authenticating cell lines in biotechnology: general requirements and considerations

ISO/TS 23511:2023

International standards serve as a benchmark for governments and regulatory bodies, which is essential for regulatory compliance. They facilitate the widespread acceptance of biotechnological products by streamlining regulatory procedures, harmonizing regulations across various jurisdictions, and coordinating regulatory frameworks.

International standards compliance can speed up market access for businesses, promoting global trade and innovation.

ISO/TS 23511:2023 is one of those standards

In the context of biotechnology, this document defines terms related to cell line authentication. It outlines the general guidelines, prevention measures, and analytical techniques for cell line authentication.

For method choice, quality control parameters, data analysis, and reporting, it outlines the necessary conditions and important factors.

In the context of basic research, translational studies, and product manufacturing, this document is applicable to routine inspection of cell lines in culture and in storage.

In academic and commercial laboratories, cell banks, and manufacturing facilities, it is also applicable to cell line origin validation. It mainly applies to mammalian cells, which includes human cells.

Non-animal cells (such as plant or bacterial cells, etc.) are not covered by this document.

g. microbial contamination, plant cells), nor to cells in intricate matrices (e.

g. tissues, organs, organoids, and plants).

Important moral issues surrounding genetic engineering, human health, and the environment are brought up by biotechnology. International norms provide ethical principles and guidelines that support ethical biotechnology research and development practices. They safeguard the welfare of individuals as well as the well-being of society at large by addressing issues like informed consent, privacy protection, and equitable access to biotechnological advancements.

General requirements for the design of packaging to contain cells for therapeutic use in biotechnology and bioprocessing

ISO 20404:2023

Collaboration among researchers, scientists, and institutions across the globe is facilitated by international standards. They encourage the exchange of research data, methodologies, and best practices, hastening the advancement of science. Standardization makes it easier for experimental results to be replicated, compared, and interoperable, allowing researchers to expand on their body of knowledge and work together more successfully.

ISO 20404:2023, for example, governs the qualities mentioned above.

The general requirements and factors for the design of packaging used to hold cells for therapeutic use are laid out in this document.

The packaging described in this document is appropriate for both the starting and intermediate materials used to create cells and their therapeutic end products.

The following do not apply to this document.

NOTE 1 Annex A contains examples of packaging, packages, and shipping containers.

NOTE 2 The design of packaging incorporates procedures to guarantee that the designed packaging is produced in accordance with the required specifications through trial manufacturing, testing, and the application of quality management.

NOTE 3 Certain topics covered in this document may also be subject to national, regional, or international laws or regulations.

Biotechnology companies can demonstrate regulatory compliance by adhering to international standards, facilitating market access and global trade.

Compliance lowers trade barriers and administrative roadblocks, allowing businesses to reach a larger customer base and broaden their global footprint.

It encourages the biotechnology sector's investment, job creation, and economic expansion.

Provenance information model for biological data and material — Part 1: Design principles and general requirements — Biotechnology

ISO/TS 23494-1:2023

International standards define detailed quality control procedures, product requirements, and safety procedures for biotechnological products.

Following guidelines like ISO/TS 23494-1:2023 ensures uniform quality and safety across regions, defending consumer and public health interests.

Both businesses and end users ultimately gain from standardization because it reduces the likelihood of product recalls, liability lawsuits, and reputational damage.

This document outlines requirements for provenance data interoperability and serialization as well as a general concept for a provenance information model for biological material and data. The provenance information model includes data originating from analytical procedures applied to the biological material, results from additional mathematical processing of the data, and 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.

Organizations, governments, and industries that are: are all covered by this document.

a) collecting, processing or distributing biological material for research; .

b) creating, gathering, analyzing, or storing data regarding biological material.

This document does not cover the use of biological data and material for purposes other than research or in industries subject to local, regional, or international legal restrictions, such as food production or the diagnosis and treatment of disease.

NOTICE Specific topics covered in this document may also be subject to national, international, or regional regulations or requirements.

Continuous communication, instruction, and capacity building are crucial to maximizing the advantages of international standards.

The standardization process must involve all relevant parties, such as scientists, policymakers, business representatives, and consumer advocates.

To keep up with new technological developments and adapt to changing societal needs, international standards also need to be continuously monitored, evaluated, and updated on occasion.

Importance of applying international standards to improve outcomes

Diverse regulatory structures, various cultural contexts, and the quick pace of technological development present challenges that call for careful thought.

To overcome these obstacles and create a solid framework for standardization, cooperation between governments, industry stakeholders, and international organizations is required.

Standards support sustainable economic growth by ensuring the high quality, security, and moral integrity of biotechnological products and processes.

They also promote international cooperation. By embracing international standards, the biotechnology sector can realize its full potential and help address urgent global challenges while also enhancing the standard of living for people everywhere.



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