Biomaterials generated during pharmaceutical R&D processes continue to grow exponentially in volume, type and complexity. These materials—cell lines, active pharmaceutical ingredients, finished products and clinical trial samples such as plasma—are invaluable to biopharmaceutical developers. Not only do they represent today’s multi-million dollar research investments and tomorrow’s multi-billion dollar potential revenue, but they are irreplaceable assets that can bring significant long-term value to the organization from a commercial, scientific and medico-legal perspective.

Even during the storage phase, these clinical trial samples represent substantial market value (some value-add and some direct financial returns). For instance, pharmaceutical and biotech firms regularly conduct a variety of testing, auditing, validation and qualification processes on stored samples to:

•    Reduce the time it takes to bring new drugs to the market, thus maintaining a competitive edge

•    Expedite R&D processes for new pharmaceuticals and therapeutics

•    Identify biological and genetic factors responsible for different drug responses across individuals or populations

•    Detect new biomarkers

•    Contribute to ongoing research, medical education and examination of disease processes over time

•    Understand disease history and detect future diseases

•    Prevent drugs from being withdrawn from the market by proving that unexpected adverse effects could not have been predicted during clinical trials

Given these considerations, many major Pharma firms are committed to storing more than one million samples per year and preserving them for the lifespan of their drugs, a timeframe that can exceed 50 years. As such, long-term storage and handling of pharmaceutical biomaterials is becoming an increasingly critical and strategic component of the worldwide drug development process.

Excellence through Expertise

To maximize margins and efficiency in a highly competitive and regulated environment, biopharmaceutical firms are increasingly turning to specialized outsourcing providers to manage resource-intensive non-core functions. Biomaterial storage, management and logistics fall squarely into this category. These services are particularly well-suited to outsourcing due to their required capital investments in equipment, facilities, trained personnel, technology, security and transportation infrastructure. Additionally, Pharma firms are outsourcing their storage operations with increased frequency because of escalating and costly industry regulations regarding audit trails, reporting requirements, business continuity practices and handling procedures.

The cost of building and maintaining a world-class biorepository is staggering. For example, a single industrial freezer can cost upwards of $10,000; however this is merely a fraction of the total cost required to develop, staff and sustain a fully compliant storage facility. Hard costs and time are incurred in:

•    Building specialized, secure facilities with dedicated, scalable storage space

•    Purchasing state-of-the-art equipment

•    Developing or purchasing software for inventory and logistics management

•    Establishing a sophisticated cold chain logistics infrastructure that spans pick up and delivery, handling, processing and storage at exacting temperatures and conditions

•    Hiring skilled personnel with expertise in biomaterials storage, logistics, sample management, quality assurance, operations and clinical laboratory management

•    Maintaining staff training, certifications and accreditations

•    Validating equipment, technology and processes

•    Developing standard operating procedures and business continuity plans

•    Ensuring adherence to an expanding array of complex industry guidelines and regulations

Outsourcing these complex and specialized functions to biorepository experts helps biopharmaceutical firms mitigate risks and allows them to allocate capital and resources to their primary mission—contributing to worldwide medical and scientific communities by developing novel pharmaceuticals and therapeutics to promote health and well-being.

Cost is Not The Only Factor

While controlling costs is critical to the success of any business initiative, low price should never be the primary motivator when selecting a biorepository partner. Given the strategic importance of long-term biomaterial storage, it is an extremely risky proposition to outsource these functions to the lowest-priced vendor if that organization is not qualified for the task at hand. Cost must be considered as one component in a broader set of selection criteria which are described in detail in the following sections.

Making the Cut

The demands of long-term sample integrity and regulatory compliance necessitate consistency, due diligence and methodical application of processes and standards. There are several critical baseline requirements that a biostorage provider must meet before it can even be moved to the short-list of potential candidates. The provider must:

•    Employ personnel who are trained, professional, reliable, accountable and attentive to detail

•    Hire only experienced cold chain logistics, quality assurance, clinical and pharmaceutical development staff

•    Demonstrate an unparalleled commitment to quality at all stages of business from sample processing and storage to auditing and reporting

•    Take a vested interest in its clients’ businesses

•    Be willing and able to work side-by-side with clients, providing ongoing advice and responsive solutions to day-to-day storage challenges

•    Adhere to HIPAA, GTP (Good Tissue Practice), GMP (Good Manufacturing Process) and GLP (Good Laboratory Practice) guidelines to ensure that samples are shipped, stored and handled safely and securely

•    Comply with FDA Title 21 CFR Part 11 to ensure that electronic records are managed according to industry regulations

•    Follow well-documented and centralized standard operating procedures (SOPs)

•    Institute appropriate biosafety processes for containment of organisms and protection of staff in accordance with CDC, NIH and DOH guidelines

•    Develop proactive, strategic programs and services designed to meet the changing needs of the biopharmaceutical industry

•    Demonstrate long-term business and financial viability

Narrowing the Field

If a biostorage provider meets the baseline requirements, the next step is to carefully and thoroughly evaluate its competencies in three key functional areas:

•    Shipping and Logistics

•    Biomaterial Storage

•    Sample Management and Tracking

Shipping and Logistics

The ideal biomaterial storage partner must demonstrate proven strategic expertise in cold chain logistics and management to ensure that temperature-sensitive samples and specimens do not degrade during packing, shipping, processing and long-term storage.

Critical cold chain logistics services and expertise that should be included in the evaluation process include:

•    Processes and systems that continuously monitor and track sample movement, handling and storage

•    End-to-end logistics management services, including planning, on-site supervision and packing, regulatory compliant packaging, shipping, tracking, delivery confirmation and audit trail recording for each individual sample or specimen

•    IATA (International Air Transport Association) certification to ship dangerous goods and infectious substances

•    Partnerships with reputable couriers and leading worldwide ground and air transportation carriers

•    Mobile logistics and transition management teams that can package and ship samples between any locations

•    Emergency short-term or long-term storage and transition services

•    Specialty in transportation regulations from U.S. Customs, DOT and foreign countries

•    Dedicated, reserved biorepository storage space that can be utilized in the case of emergency sample relocation

Biomaterial Storage

Samples must often be maintained in highly-specialized and consistent conditions, often for decades, before they need to be retrieved for research, testing, validation or audits. It is extremely important that the partner is a dedicated biorepository facility that views cold chain logistics and biostorage as critical, strategic business functions. Often, storage is a secondary priority to businesses that bill themselves as “biorepositories,” and these firms may not have the experience, capability or inclination to properly care for samples. Nor will they offer the breadth and depth of services that a dedicated biostorage expert provides.

To maintain sample integrity for such long periods of time, standardized, secure and compliant storage is critical. Factors that must be evaluated include:

•    A facility capable of storing specimens at a wide range of temperatures, including:

    o    Ambient (20° to 25°C)
    
    o    Cold Room/Refrigerated (2° to 8° C)
    
    o    Ultra-Low/Ultra-Cold (-20° to -95° C)
    
    o    Vapor Phase Nitrogen (-135° to -190° C)

•    Reliable, state-of-the-art industrial-grade freezers, refrigerators and temperature monitoring equipment

•    The ability to locate, retrieve and ship one or many samples, on-demand

•    Sophisticated, redundant power and data backup systems

•    Secure facilities with sophisticated smoke detection and fire suppression systems

•    Card-controlled access, video surveillance, burglar alarms and other physical security measures

•    Compliant, validated equipment, processes and software systems

•    Business continuity and disaster response plans

•    Service level agreements with guaranteed sample retrieval and shipping response times

•    A strategic geographic location away from natural disaster zones and close to convenient and cost-effective transportation and shipping options

•    Dedicated, available storage space to accommodate growth and emergency storage needs

Sample Management And Tracking

Proper storage, while critical, is just one of many factors in a complex equation. An equally important challenge is maintaining control and visibility of large quantities of stored biomaterials so specific samples or specimens can be accounted for and located quickly. After all, proper storage is a wasted effort if specific samples cannot be retrieved when they are needed for testing or ongoing development.

The ideal partner should offer an electronic sample inventory management system that eliminates paper-based tracking and reporting processes through all stages of a sample’s shipping, handling and storage lifecycle. A professional software solution will:

•    Track stored samples with pinpoint accuracy

•    Offer realtime access to sample inventory data via the Internet

•    Allow users to print reports and schedule shipments or deliveries 24 hours a day

•    Provide the status of specific shipments at any given moment

•    Verify that samples have been handled and stored in optimal conditions from receipt to storage to retrieval

•    Provide complete electronic audit trails and FDA compliant reports

A well-designed sample inventory management system must also be capable of recording and reporting on the following details on a sample-by-sample basis:

•    Handling history (e.g., dates, times and employees)

•    Exact location, from freezer to shelf to package position

•    Linking of all parent samples and aliquots

•    Storage, shipping and sample temperature conditions and history

•    Associated data and documentation (e.g., disease parameters and shipping manifests)

Choose a Leader

In addition to the capabilities and services outlined in this article, an ideal biorepository partner should meet one final requirement: it should be a true industry innovator. The company should support your organization’s storage, logistics and management needs today and be prepared to grow with your changing requirements over time. It should be leading the industry and setting the standard for quality and service. And, it should set the curve, not follow it by merely responding to mandated industry regulations or reacting to competitive pressures.

Don’t Cut Corners

As demonstrated by the guidelines in this article, selecting a biorepository partner is a complex, strategic proposition. The risks associated with choosing the wrong partner can be devastating, so this is not a process that can be taken lightly. Only by carefully screening and evaluating all of the available options can you identify those businesses that operate with a partnership focus, not a “vendor” mentality.

While there are many individual factors to consider, the bottom line is simple: your outsourced biorepository provider must prove itself to be a trustworthy, accountable and viable business partner that will be around to protect the integrity of your samples for one, five, 10 or 50 years. It must be able to retrieve individual samples on demand, deliver them next day and always keep your business interests top of mind.

F. John Mills, M.D., Ph.D., is the chief executive officer and chairman of BioStorage Technologies, Inc. He previously oversaw global clinical research, management and support at Covance, Inc. and Janssen Pharmaceutica, a division of Johnson & Johnson. His broad range of expertise includes extensive knowledge of pharmaceutical development. He can be reached at john.mills@biostoragetech.com.