Building a biorepository: Weighing the benefits and drawbacks
Category | Clinical Trial Services
The continued growth of groundbreaking advanced therapies owes part of its success to the meticulous collection, preservation, and utilization of highly valuable but temperature-sensitive biological materials, and biorepositories serve an invaluable role in the preservation of these critical materials.
As biopharma companies advance through their research and clinical trials, they may ask themselves an important question: should we build or buy a biorepository?
The answer can be quite complex and varies from organization to organization. After all, every research project has its own unique goals. Additionally, collections of biological materials can differ tremendously in size, scope, handling constraints, and storage requirements.
When weighing the benefits and drawbacks of building vs. buying a biorepository, it’s essential to understand what’s most important: maintaining control over every aspect of sample storage or saving time, money, and human resources.
Establishing a biorepository in-house provides greater control and ownership over the entire process, allowing biopharma companies to tailor the biorepository to their specific needs, which helps to ensure high-quality storage conditions and maintain strict governance over samples. However, the initial set-up costs can be considerable, involving investments in state-of-the-art equipment, skilled staff, and dedicated infrastructure — not to mention the ongoing costs for normal operations and potential future expansions.
In this post — the first in a two-part series — we examine the pros and cons of building a biorepository. Part two of the series considers the advantages and disadvantages associated with buying a biorepository.
Pros of building a biorepository
- Control: Creating a biorepository grants a biopharma company full control over biosample collection, handling, and storage. This control extends to proprietary information, problem-solving capabilities, organizational costs, and compliance with federal, state, and local regulations. It's crucial to note that biorepositories must adhere to various regulatory guidelines from different levels of government.
- Accessibility: An on-site biorepository ensures both quick and easy access to biosamples and their constant availability, thus eliminating the need for time-consuming and expensive sample transportation.
- Customization: Biorepositories can be tailored to meet precise research requirements. Therefore, biopharma companies must consider factors such as mechanical freezers, liquid nitrogen storage, laboratory information management systems (LIMS), duration of storage, and even temperature-controlled sample processing laboratories.
- Adaptability: When biopharma companies run their own biorepository, they can adjust collection, handling, and storage conditions as their needs evolve.
Cons of building a biorepository
- Time: Establishing a biorepository takes time. Renovation of warehouse space, depending on the size of the facility, can take six to 18 months for design and approval, permits, construction, equipment, validations, and start-up activities. Construction from the ground up requires an additional nine to 18 months. The delays associated with building a biorepository may impact research or clinical trial objectives.
- Expense: Biorepositories are more than “just” storage. The full scope of what they require for operation, including support systems and personnel, should be factored into the cost/value equation. For instance, a reasonable budget for basic construction is $200 to $250 per sq. ft., but additional costs include electrical switchgear which can be hundreds of thousands of dollars (backup generators cost an estimated $500,000), temperature monitoring systems (approximately another $100,000), and additional costs for redundant storage units and emergency services. Further, annual operating costs can run between $18 to $34 per sq. ft.
- Personnel: Hiring, training, and maintaining specialized staff requires significant resource allocation. This includes the need for continuous investment in personnel development, which could divert resources from core research activities. Additionally, if the in-house team lacks expertise or experiences turnover, it may lead to delays, errors, or compromised data integrity, jeopardizing the overall efficiency and reliability of the biorepository.
Ultimately, the decision to build a biorepository should be based on a careful assessment of the biopharma company’s current resources, research goals, budget constraints, and project timelines. While building provides customization and control, it comes with higher upfront costs and time commitments. Conversely, buying a biorepository offers convenience and potential cost savings but may limit customization and control. Many organizations choose a hybrid approach, where they build some infrastructure but also partner with CDMOs to leverage their expertise and capabilities.
Learn more about Thermo Fisher Scientific’s cold and ultra-cold supply chain management and logistic services here
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