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.