Everything you Need to Know about Biorepositories

May, 2024 | General

What is a Biorepository? 

A biorepository is a secure facility that stores biological regulated material from humans, animals, and/or plants for research, development, and regulatory compliance. 

Who Needs to Use a Biorepository? 

Some of the most common biorepository partners include universities, biopharma, healthcare, biodefense, and agricultural companies. Any company or institution that is developing new drugs or regulated material to improve the lives of people, animals, and plants may need a qualified biorepository. 

A GxP biorepository can store a range of study materials from GLP, GMP, GCP, and more.  

Why are Biorepositories Becoming More Popular? 

The purpose of a biorepository is to store millions of new specimens, samples, and other regulated material being created each year that require secure cold preservation, a compliant and auditable chain of custody, and rapid retrieval to afford future evaluation. 

The regulated material created from R&D studies is sensitive intellectual property and is managed under strict regulations. By specializing in the preservation and compliance of regulated material management, a biorepository can satisfy critical archiving requirements so companies, universities, and sponsors can focus on new product development. 

As the drug development timeline rapidly accelerates due to technological advances, more regulated material needs to be archived, and most research organizations have run out of space to store material or don’t want to specialize in archiving. With limited space and studies scattered around the world, healthcare companies are experiencing increased pressure from a regulation and cost perspective. Biorepositories are being created to support the rapid pace of new product development and support future biomedical research. 

What Does a Biorepository Look Like? 

A biorepository looks like a warehouse from the outside, but it’s an incredibly specialized building.  

On the outside, a biorepository needs to be located in a geographically secure area to protect against natural disasters like hurricanes, tornadoes, earthquakes, or fire. Biorepositories should have a robust shell and insulation along with security systems, pest control, and backup generators. Entrances should also be secured along with a loading dock for inbound and outbound shipments. 

On the inside, a biorepository has a full range of storage environments depending on the type of regulated material being stored. Oftentimes, there is space for controlled ambient pallet storage, refrigerated pallet storage, walk-in refrigerators, freezer storage, and even cryogenic storage. All of these environments can range from +21°C (controlled ambient) down to -150°C (cryogenic). That’s cold! 

When creating a qualified GxP biorepository, there are many best practices to consider including a purpose-built design, environmental management, and separate temperature zones carefully designed to accommodate varying storage requirements. The placement of equipment, racking systems, and HVAC modules all play a role in efficient space utilization to enhance workflow and accessibility. 

What’s the Difference Between a Biorepository and a Cold Storage Warehouse?  

An archive/biorepository is a specialized facility that is qualified and maintained according to strict regulations, audits, and standards and staffed with specially trained people and emergency response teams. Cold storage warehouses are built and operated to store commodity goods that are highly perishable and mostly support short-term storage of food products. A general cold storage warehouse is not fit to be a biorepository. 

What are the Benefits of Using a Biorepository? 

Partnering with an expert biorepository takes all of the archiving and auditing headaches off of your plate. Here are some of the benefits of working with GXP-Storage: 

Extended Material Lifecycle 

Every living cell has a clock, and research has shown that freezing cells drastically slows down that clock lifecycle. The controlled temperature environment in biorepositories helps to extend the life cycle of living, perishable materials. This reduces the risk of spoilage and waste while ensuring regulatory compliance for years. Some materials like vaccines and research samples need to be stored for decades, and this is accomplished through cold storage. By having storage options for a range of materials, biorepositories can maximize the life of cells for future use and research. 

Complete Regulatory and Safety Compliance 

Maintaining optimal temperature conditions throughout the storage and distribution process helps preserve the quality, potency, and safety of regulated materials. Using an industry-leading biorepository leads to a positive impact on customer satisfaction, brand reputation, and confidence in regulatory compliance. Instead of hosting quality assurance (QA) checks at your own facility, GXP-Storage ensures compliance with all GxP regulations and takes care of it. Using an approved biorepository vendor takes the confusion out of compliance. 

Efficient Supply Chain Management 

Biorepositories consolidate the entire process by facilitating material management, indexing, retrieval, and global distribution. GXP-Storage has decades of experience planning, consolidating, handling, and providing a documented chain of custody for the international distribution of your regulated material. Materials must be securely stored for years while simultaneously accessible 24/7. 

Lower Costs 

Research facilities and hospitals have small biorepositories on-premise, but storage isn’t their objective. Research facilities may hold on to materials for a short period of time, but their cost adds up rapidly. Hospitals have future biomedical research (FBR) storage, but space is limited and samples aren’t always stored properly. By specializing in storage, biorepositories are more economical while ensuring compliance every step of the way. 

Market Expansion Opportunities 

Dependable biorepositories enable businesses to accelerate their market reach by delivering on research and development while outsourcing material archiving and compliance. Biorepositories offer complete peace of mind and give the flexibility to tap into new markets and meet diverse customer needs. 

Summary  

Biorepositories are a vital component for the biopharma, healthcare, and agriculture industries that rely on the safe storage and distribution of regulated materials. By leveraging the benefits of controlled temperature environments, businesses can ensure the quality, security, and longevity of their materials with the option to retrieve at any time. Incorporating a contract service biorepository into your operations sets the stage for improved supply chain efficiency, complete management and compliance, and the opportunity to focus on what you do best: research and development. 

 

Sources and Additional Resources 

GXP-Storage offers compliant GxP solutions tailored to meet your requirements.

With decades of combined experience, we specialize in offering scalable storage solutions in our purpose-built restricted access facilities along with our 21 CFR Part 11 compliant validated inventory management system: GXP-Guardian℠. To learn about how we can help you consolidate and manage your research and manufacturing material, contact us or download our information sheet below.

Talk to a GXP-Storage expert. We offer confidential consulations to assess your needs and design a tailored solution.

Realize the benefits of the GXP-Storage Standard

To learn about how we can help you manage your regulated research and manufacturing material, download our information sheet.

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