ISO 20387 and Other Biobanking Quality Standards
ISO 20387 and other biobanking quality standards ensure sample reliability & ethical use, impacting research quality & regulatory compliance
Why Quality Standards Matter
Biotech companies looking to source biospecimens for research must be sure that they come from biobanks that follow accepted biobank quality standards.
Biobank quality standards ensure the reliability, integrity, and ethical procurement of the biospecimens. These factors directly affect the quality of research, regulatory compliance, and overall success of biotech projects, as described below:
1. Ensuring Sample Integrity and Reliability
High-Quality Specimens: The integrity of biospecimens is crucial for accurate and reproducible research results. Biobank quality standards ensure that the biospecimens are collected, processed, and stored in a way that preserves their biological properties, minimizing degradation or contamination.
Consistency: Adherence to standards like ISO 20387 ensures that the samples provided by the biobank are consistent across batches, allowing for reliable comparisons and valid conclusions in research.
2. Regulatory and Legal Compliance
Meeting Regulatory Standards: Biotech companies often need to adhere to stringent regulatory requirements when developing new therapies, diagnostics, or conducting clinical trials. Sourcing biospecimens from biobanks that follow recognized standards (e.g., ISO, OECD, or GCP/GLP) ensures that the biospecimens comply with international regulatory expectations.
Avoiding Legal Risks: Biobanks that follow best practices ensure proper documentation of donor consent, privacy, and ownership of materials. This reduces the risk of legal issues around bioethics, intellectual property, and data protection for biotech companies.
3. Research Reproducibility
High-Quality Data: The accuracy of research findings, particularly in drug development and biomarker discovery, depends on the quality and traceability of the biospecimens used. Biobank quality standards provide a framework for accurate data annotation, traceability, and validation, which is essential for the reproducibility of research.
Minimizing Experimental Variability: When samples are sourced from biobanks that follow standardized protocols for collection, processing, and storage, biotech companies can trust that sample variability is minimized, reducing confounding factors in experiments.
4. Ensuring Ethical Sourcing
Ethical Compliance: Biotech companies are often under public scrutiny for the ethical sourcing of biological materials. Biobanks that adhere to ethical standards, such as proper informed consent and the protection of donor privacy, reduce the risk of ethical violations that could damage the company’s reputation.
Public Trust: Transparency in the handling of biospecimens, as defined by biobank quality standards, reassures biotech companies that they are working with ethically sourced materials. This is crucial in maintaining public trust, especially when developing products that directly impact human health.
5. Regulatory Submissions and Approvals
Validation for Drug Development: For companies involved in drug development or diagnostic tools, biospecimens used in preclinical or clinical research often need to meet specific standards to be acceptable for regulatory submissions. Sourcing from biobanks that comply with standards such as ISO 20387 or CAP accreditation can provide the necessary documentation for regulatory authorities.
FDA and EMA Requirements: Regulatory bodies like the FDA (Food and Drug Administration) and EMA (European Medicines Agency) often require companies to provide evidence that the biospecimens used in clinical trials or research were handled under controlled conditions, with full traceability and proper ethical oversight.
6. Market Access & Commercialization
Faster Product Development: By ensuring that biospecimens are of high quality and meet regulatory and ethical standards, biotech companies can streamline the process of developing new therapies, diagnostics, or other medical products, allowing faster market access.
Commercial Value: High-quality biospecimens enhance the validity of research outcomes, improving the chances of commercialization success for biotech products.
7. Conclusion
In summary, understanding and adhering to biobank quality standards allows biotech companies to ensure the integrity, reliability, and ethical handling of the biospecimens they source. This has a direct impact on the quality of their research, regulatory compliance, risk management, and ultimately, the success of their products in the healthcare and life sciences market.
Biobank Certification / Accreditation
Some biobanks obtain certification and/or accreditation to show that they follow quality standards. Here are some examples of biobank quality standard certification and accreditation:
ISO 20387:2018
Purpose: ISO 20387 is the international standard specifically created for biobanks. It provides guidelines for the establishment, implementation, maintenance, and continuous improvement of quality management systems in biobanking. It allows for biobank certification and also accreditation.
Scope: This standard covers both human and non-human biological materials, along with associated data. It applies to the entire lifecycle of sample management, including acquisition, storage, distribution, and destruction of samples.
Key Areas: Sample handling, quality control, personnel competence, equipment management, documentation, and data security.
ISO 9001:2015
Purpose: While not specific to biobanks, ISO 9001 provides a broad framework for quality management systems in any organization. It focuses on customer satisfaction, continuous improvement, and effective operational processes. It allows for biobank certification.
Scope: Biobanks can use ISO 9001 to establish a general quality management system that complements specific biobank standards like ISO 20387.
Key Areas: Process management, risk management, documentation, and corrective actions.
NF S96-900
NF S96-900 is a French national standard for biobanks and biological resource centers that ensures the quality and traceability of biological samples for research and therapeutic purposes. It allows for biobank certification and also accreditation.
Purpose: To establish a quality framework for biobanking operations, ensuring the reliability, safety, and ethical handling of biological samples.
Scope: Applicable to biobanks in both public and private sectors, covering the collection, processing, storage, and distribution of biological materials.
Key Areas: Quality management system, sample traceability, ethical and legal compliance, storage and preservation, safety and risk management, and continuous improvement.
CAP Biorepository Accreditation
Purpose: The College of American Pathologists (CAP) Biorepository Accreditation Program helps biobanks implement high-quality standards, specifically focusing on pathology and laboratory-based biorepositories.
Scope: This accreditation is geared toward biobanks involved in clinical research and diagnostics, especially those associated with healthcare institutions.
Key Areas: Specimen collection and processing, personnel qualifications, quality control, recordkeeping, and compliance with ethical and regulatory requirements.
CTRNet Biobank Certification Program
- Overview: The Canadian Tissue Repository Network (CTRNet) Biobank Certification Program standardizes quality management and operations for Canadian biobanks, and is also used internationally.
- Key Focus: The CTRNet guidelines cover biospecimen collection, processing, storage, and distribution, with an emphasis on quality, ethical considerations, and legal compliance. It integrates internationally recognized standards like ISO 20387 while considering Canadian-specific regulatory requirements.
- Certification Process: Biobanks can apply for certification through CTRNet, ensuring that their operations meet high-quality standards. Certification helps biobanks align with national and international research initiatives.
Mandatory Guidelines
In many countries, biobanks are subject to a range of mandatory guidelines and regulations. These regulations are designed to ensure the ethical, legal, and scientific integrity of the biobanking process, particularly when dealing with human samples. Below are some examples of mandatory guidelines:
UK - HTA Codes of Practice
Purpose: In the UK, the Human Tissue Authority (HTA) Codes of Practice provide organizations that store and use human tissue, including biobanks, with practical advice on the minimum steps necessary to comply with the relevant legislation and HTA policy.
- The HTA Codes of Practice are mandatory guidelines that licensed establishments must follow to comply with the Human Tissue Act 2004, but they do not lead to certification or accreditation.
- Institutions, including biobanks, that store human tissue for research purposes must obtain an HTA license, and compliance with the HTA’s standards and codes is required to maintain this license.
- While the HTA may inspect establishments and take action for non-compliance, following the HTA Codes of Practice does not result in an external certification or accreditation like ISO or CAP standards.
Scope: Focuses on the ethical and legal use of human tissues, particularly with respect to consent and the respectful treatment of human biological materials.
Mandatory: Yes
Key Areas: Consent, governance, disposal, recordkeeping, and traceability.
Spain - Royal Decree 1716/2011
Scope: Implements Law 14/2007 by providing specific regulations for the operation of biobanks, as well as the donation and use of human samples for biomedical research.
Mandatory: Yes
Details:
- Regulates the creation, organization, and functioning of biobanks in Spain.
- Establishes mandatory licensing and registration of biobanks with the Spanish Ministry of Health.
- Biobanks must meet strict quality and safety standards, as well as provide guarantees for the confidentiality and proper use of personal data.
- The use of biological samples is subject to specific consent conditions, and biobanks must ensure that samples are used in line with the donor’s consent.
- Biobanks are required to report on their activities and comply with the Ministry of Health’s regulations on the distribution and use of samples.
France - Public Health Code
Scope: The Code de la Santé Publique (Public Health Code) contains regulations related to biobanking, specifically in the context of healthcare and research.
Mandatory: Yes
Details:
- Article L1243-4 and subsequent articles govern the operation of biobanks, referred to as tissue and cell repositories (banques de tissus et cellules).
- Biobanks must be authorized by the Agence de la Biomédecine (French Biomedicine Agency) to collect, store, and transfer human biological samples.
- Biobanks must comply with strict standards related to quality control, traceability, and data protection.
- Requires biobanks to have proper infrastructure and ensure the long-term preservation of biological materials.
EU - General Data Protection Regulation (GDPR)
Scope: Protects the privacy of personal data, including data from biological samples used in biobanking.
Mandatory: Yes
Details: Biobanks in the EU must comply with GDPR to ensure that personal data associated with samples is processed lawfully, transparently, and securely. This regulation impacts consent procedures, anonymization, and the sharing of data.
USA - Common Rule (45 CFR 46)
Scope: Governs the ethical conduct of research involving human subjects, including the use of human biospecimens in research.
Mandatory: Yes
Details: Biobanks involved in federally funded research must comply with the Common Rule, which focuses on informed consent, ethics review by Institutional Review Boards (IRBs), and the protection of human subjects.
USA - HIPAA
Scope: In the USA, the Health Insurance Portability and Accountability Act (HIPPA) protects the privacy and security of individuals’ health information.
Mandatory: Yes
Details: Biobanks that handle identifiable health information in the U.S. must comply with HIPAA to ensure the privacy and confidentiality of participants’ health data.
Australia - National Statement on Ethical Conduct in Human Research
Scope: Provides guidelines for the ethical conduct of human research, including the use of human tissue.
Mandatory: Yes
Details: Biobanks must adhere to this statement, which covers consent, privacy, and the ethical use of human tissue in research. The Human Research Ethics Committee (HREC) must review and approve biobanking protocols.
Canada - Tri-Council Policy Statement
The Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2):
Scope: Sets ethical standards for research involving human subjects, including biospecimens.
Mandatory: Yes
Details: Biobanks must follow TCPS2, which emphasizes informed consent, ethics approval, and the responsible use of human samples. Institutional Research Ethics Boards (REBs) review biobanking projects for compliance.
Webinars
“ISO 20387: Conformity Assessment for Biobanking and its Industrial Relevance” – a webinar by Clare M. Allocca PMP, Senior Advisor for Planning and Outreach, National Institute of Standards and Technology (NIST), MD, USA
“Paving the path towards the highest international quality standards in biobanking” – a webinar by Agnieszka Matera-Witkiewicz PhD, Head of the Wroclaw Medical University Biobank, Wroclaw, Poland.
“Importance of Biospecimens in the Drug Development Process for PTSD and TBI” – a webinar by Nicole Bjorklund, PhD, Director of Translational Research & Development at Cohen Veterans Bioscience, New York, USA.
