Biobanks collect and store a large number of biospecimens predominantly for health and medical research. The process is known as biobanking which includes everything from collection, preparation, preservation, analysis, and distribution of biological samples as well as associated data. The need to set up more biobanks has been increasing with the increasing demand for tissues and samples for biomedical research and translational studies. Biobanks must have documented standard operating procedures (SOPs) for all biobanking processes.

Are You Planning to Set Up a Biobank?

It is essential to understand the aim, funding, and scale of your project before setting up a biobank. You need to zero in on the type of biobank you want to set up. Following are some of the types of biobanks:

• 1. Disease-centric Biobanks: Disease-specific biobanks collect samples related to a specific disease.
• 2. Population-based Biobanks: These biobanks collect samples from the general population for use in broad-spectrum research.
• 3. Project-based Biobanks: These biobanks collect samples for a specific clinical trial.
• 4. Virtual Biobanks: These biobanks collect, store, and maintain sample data digitally and support transnational collaboration.

You can have a combination of all types depending on your needs.

Factors to Consider When Setting Up a Biobank

1. Sample Types

Biobanks need to securely process and store the collected samples to assure sample quality. Depending on the type of biobank you are planning to set up, you need to collect samples. To store fit-for-purpose samples, it is important that your samples meet the quality standards and have annotated metadata. Biobanks need to consider factors, such as sample transportation and sample preservation, based on the types of samples they collect and store.

2. Equipment

You need to purchase equipment based on the size of the biobank, your budget, the types of samples you need to process and store, and the available physical space of your biobank. A few common types of equipment needed in a biobank include:

• Freezers: Select a freezer based on the type and expected number of samples you need to store. You can also customize the number of racks in the freezer based on your needs. Freezer gloves are another important thing to have.
• Liquid Nitrogen Systems: These are needed if the samples need to be stored in liquid nitrogen for cryopreservation.
• Generators: It is important to have backup power for freezers and other equipment in your biobank. You also need to have a sufficient number of uninterrupted power supplies (UPS) to commence an alternate power supply as soon as it goes off.

A biobank should always have surplus storage systems, racks, and storage boxes. It is also essential to monitor important parameters, such as temperature and humidity, by installing equipment monitoring systems. This is crucial to prevent deterioration in sample quality due to temperature fluctuations or abnormal humidity.

3. Physical Space

This is an important aspect of a biobank. You need a fairly large physical space as congested and poorly ventilated spaces are more prone to sample contamination. You may need to decide the exact area based on the space needed to accommodate freezers, generators, backup equipment, staff, and process samples.

4. Disinfectants

It is essential to maintain biological safety in your biobank. Biobanks need to follow standard guidelines for the disposal of bio-hazardous and non-hazardous waste. Depending on the samples you work with, you need to determine the level of biosafety and the type of disinfectants required. At your biobank, you must take all possible measures to prevent sample cross-contamination and should adopt a good disinfection method.

5. Contingency Plans

Contingency plans are emergency plans you must keep ready to fight potential hazards. It is important to identify the risks and effectively address them. You should conduct emergency response tests to assess the effectiveness of the emergency response. You must have a written agreement with reliable vendors for emergency delivery of resources. An emergency contact list of staff members and other stakeholders is a must for disaster management.

6. Governance, Budget, & Ethics

Your biobank should have well-trained staff to carry out day-to-day operations. A team of advisors, decision-makers, and administrators should be present among your staff members. You should estimate your expenses well to decide on the overall budget for setting up a biobank. You need to estimate the entire budget based on the cost of setup, products, services, and staff expenses. A biobank must comply with the ethical requirements of the country where it is located.

7. Accreditation

All commercial, third-party, or in-house biobanks need to follow regulatory guidelines and sample management best practices, such as ISO 20387:2018, EU GDPR, HIPAA, 21 CFR Part 11, and ISBER Best Practices to assure high-quality samples.

8. Software & Hardware

Digitization of biobanking operations is gaining popularity as it minimizes manual errors and increases efficiency. A laboratory software for biobanking, also known as Biobank Information Management System (BIMS) or biobanking LIMS, is crucial for automating workflows. It supports sample and data management while providing strong data security and donor privacy. You should select a BIMS that best meets your biobanking needs. A good laboratory software for biobanking should be able to securely manage samples and data, ensure data integrity by assigning role-based access to staff, meet compliance requirements, and remove data silos. Furthermore, a biobanking LIMS should be capable of securely managing patient data, documents and SOPs, maintaining a sample chain of custody, integrating with freezers and temperature monitoring systems, and scheduling staff training.

Hardware such as computers, laptops, printers, and hard drives, should be available for seamless data management.

Conclusion

Setting up a biobank requires a lot of thought processes and consideration of several factors. To meet the growing demand for high-quality samples and to comply with all operational and regulatory requirements, biobanks need a considerable amount of funding and resources such as equipment, staff, physical space, a laboratory software for biobanking, and hardware. You must contemplate all these factors before setting up a biobank so that the biobank fulfills the intended purposes.

The need for high-quality, annotated biospecimens has significantly increased in the recent past. This has accelerated the need for biobanks to securely store samples. All modern biobanks, including commercial, third-party, and in-house biobanks, face a complex patchwork of regulatory and ethical challenges. Biobanks face compliance challenges from ethics committees, Institutional Review Boards (IRBs), scientific boards, and regulatory agencies. Biobanks need to be legally and ethically competent and comply with the regulatory guidelines and standards.

Importance of Regulatory Compliance for Biobanks

Biobanks manage a large number of patient samples and associated metadata. This brings along multiple challenges such as risk to patient privacy and data security apprehensions. Biobanks are responsible for storing and disseminating high-quality samples without compromising patient privacy. Regulatory compliance is essential for biobanks as it helps in safeguarding sensitive donor information. It also enables biobanks to standardize operations, maintain high-quality samples, and build trust within the biobanking community and among researchers. Non-compliance could be a threat to biobanks and can lead to hefty fines, penalties, and even license cancellation. This may impact the reputation of biobanks, thus raising a question on their operational competence and the ability to provide fit-for-purpose samples.

Major Compliance & Best Practices for Biobanks

• HIPAA
  The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides guidelines to protect the sensitive data of sample donors and enforces measures to prevent disclosure of personally identifiable information of donors without their consent. The entities covered by HIPAA include biobank staff and their business associates. HIPAA requires biobanks to protect personally identifiable information (PII) of patients, securely manage data, and record all changes made to the PHI along with the reason for making the changes. Based on the severity of violations to HIPAA rules, the Office for Civil Rights (OCR) under the Department of Health and Human Services (HHS) issues certain penalties or institutes corrective actions as deemed necessary.
• EU GDPR
  The European Union’s General Data Protection Regulation (EU GDPR) governs the privacy and data of EU citizens. However, it can impose obligations on any entity that deals with the data of EU citizens, irrespective of where the entity is located. The regulation is applicable for all biobanks that store samples and data of EU citizens. EU GDPR allows the transfer of personal data of EU citizens to non-EU countries only if they have similar standards to protect the confidentiality of data. Violation of the EU GDPR attracts harsh fines and penalties that may run into millions of Euros.
• ISO 20387:2018
  ISO 20387 was published by the International Organization for Standardization (ISO) in 2018. This standard stipulates the need to maintain the quality and appropriateness of biological samples collected by biobanks and their related metadata. This standard applies to all kinds of biobanks that collect and store biological materials from multicellular organisms. This is a standard of quality that demonstrates the competence of biobanks in providing high-quality samples that are fit for use in research. Furthermore, it enables biobanks to standardize workflows and other biobanking processes for assuring quality biobank management.
• ISBER Best Practices
  ISBER Best Practices (BP) provide guidelines to biobanks on the day-to-day biobanking processes, such as collection, storage, and tracking of samples, documentation, data management, and equipment management. Biobanks should be well prepared with documentation, such as Standard Operating Procedures (SOPs), and securely maintain informed consent of sample donors to comply with the ISBER Best Practices. Though voluntary, ISBER BP enable biobanks to follow sample and data management best practices, thereby supporting transnational collaboration.
• NCI Best Practices
  Cancer is one of the leading causes of death across the globe and is one of the most researched diseases. The National Cancer Institute (NCI) best practices apply to biobanks or biorepositories that are involved in cancer research. These practices define operational, technical, ethical, and legal safeguards and guidelines that biobanks should follow to assure the quality of biospecimens and associated metadata intended for cancer research.
• 21 CFR Part 11
  21 CFR Part 11, issued by the US FDA in March 1997, permitted the use of electronic data. The standard emphasizes the need of safeguarding personal data in all electronic forms, such as documentation and signatures, and provides guidelines to protect electronic data at all times.

Biospecimen Tracking & Management Software – The Solution to Biobanking Regulatory Challenges

Biobanks can easily meet compliance and follow best practices by leveraging a biospecimen tracking & management software. A biospecimen tracking & management software, also known as a biobanking LIMS or biobank information management system, helps biobanks safeguard sensitive patient data by assigning role-based PHI access to the staff. It becomes convenient for biobanks to securely manage all internal and external documents, such as SOPs and consent forms, with a biospecimen tracking and management software. A biospecimen tracking and management software can help biobankers authenticate key activities through digital signatures while ensuring the safety of data in all electronic forms. It helps biobanks maintain data integrity and a complete audit trail to track key activities. Furthermore, a LIMS helps biobanks manage staff training, schedule equipment calibration, and generate custom reports.

Conclusion

All biobanks need to ensure patient privacy and follow best practices to maintain sample and data quality and integrity. This enforces them to comply with regulatory standards such as HIPAA, ISO 20387:2018, ISBER & NCI Best Practices, EU GDPR, and 21 CFR Part 11. All regulatory compliance provides guidelines to protect PHI and standardize biobanking operations, enabling them to stay ethical and reliable. Biobanks can easily meet governance and compliance requirements using a biobank information management system. It helps biobanks seamlessly manage sample lifecycle, securely manage documents, ensure transparency in biobanking processes, and safeguard information by limiting unnecessary access to confidential data.