Comprehensive Outsourcing Biobanking Facility to Serve the International Research Community

Introduction

In the last decade, biomedical research and pharmaceutical industries have experienced increased demands for the collection and long-term storage of biomaterials such as tissues, blood, serum, urine, and cerebral spinal fluids, which have become fundamental tools in drug development and clinical applications. ¹ This is reflected in the increased role that biobanks are playing in basic and translational medicine, as shown by the exponential increase of PubMed references reporting the use of biobanking facilities (Fig. 1) for research purposes and clinical applications. ²

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FIG. 1.

Number of PubMed references citing “biobanking” or use of “biobanks” in their title, abstract, or keywords for basic and translational research.

Pharmaceutical companies are shifting their efforts toward a more personalized medicine approach^3,4 using molecular-based findings, which, on the other hand, require the collection, transportation, and storage of a huge number of high-quality and well-maintained biosamples. ⁵ The high-throughput molecular technology platforms available require large quantities of biomaterials to be used in research and clinical trials. Today, researchers can implement a wide range of analyses on archived biospecimens, which would not have been possible 1 or 2 decades ago. However, this type of workload cannot be handled by public and/or private hospital-based institutions despite the availability of sophisticated protocols and strict guidelines (Table 1) that regulate the handling and storage of biosamples. ⁶ This imposition is mainly due to financial constraints, limitations on capital budget expenses, and the ever-increasing demand to reduce costs.

In-House or Outsourcing Biosample Storage

Given the pivotal role that biomaterials play in pharmaceutical product development, private or public institutions are faced with on-site or off-site storage options. Depending on the strategy chosen, some institutions prefer 100% control of their own storage, and others instead prefer to allocate their biosamples to experienced biotech storage organizations based elsewhere. A potential compromise could be to maintain an in-house storage suite and in parallel retain, in a different but secure location, a duplicate set of samples.

However, when choosing on-site management of biomaterials, an institution or a company needs to thoroughly evaluate whether it is able to sustain several critical aspects (Table 2). Sample storing, validation processes, tracking, and invoicing are arduous tasks that require a great deal of time from experienced personnel. To manage such operational complexity, the storage facility needs to have a rigorous and structured organization based on the following: (i) standard operating procedures to be implemented in addition to training staff to ensure proper compliance with the way materials should be processed and stored; (ii) an international biobanking consent form that must be signed to allow the sample to be used in international research studies ⁷ ; (iii) good knowledge of the international biosafety rules and regulations for handling and shipping of biomaterials to avoid unwanted custom delays; (iv) sophisticated logistics and product-tracking systems such as enterprise resources planning software, document management systems, and bar-coding to provide a complete history of the handling, status, and transfer of biospecimens. ⁸

In-sourcing the cold-chain storage and logistic functions may provisionally be a good investment, but it may become an overwhelming and expensive burden in the long run. For these reasons, many biotechnology and pharmaceutical companies are increasingly outsourcing the management of their samples to expert service providers (Table 3). It has been estimated that the costs to build a 50,000 sq ft facility ranges from $6,000,000 to $9,000,000 depending on the geographical location as well as the costs of material and labor. ⁹ In addition, the management costs to maintain high-quality standards and fulfill all the requirements for sample traceability need to be accurately considered; even if they are difficult to estimate, because of the great variability among different institutions, it is clear that centralizing these functions would help to optimize the resources and reduce the cost of each sample. It is imperative to consider that the number of biosamples or bioproducts obtained from and for clinical trials is continuously growing; therefore, the need to store and logistically manage this huge amount of samples is very challenging, requiring proper infrastructure, special expertise, technologies, and regulatory compliance. By outsourcing these functions to experts in the field, drug manufacturers and researchers can mitigate risks and expenses and focus their resources on their core competencies.

Cost Is Not the Only Factor

Compliant storage is just one of the many factors to take into consideration if the outsourcing strategy is selected.

Which then are the criteria when choosing an outsourcing partner?

Conclusion

The present biotechnology industry no longer resembles the industry of the past; its greatest challenge is to manufacture sufficient quantities of products (eg, vaccines) to meet market demand. Biomanufacturing is a complex, costly, labor-intensive process, and, coupled with labor shortage and high costs for building adequate facilities, it has prompted many companies to outsource some of their activities. To assure quality and consistency of such activities, biobanks need to follow rigorous norms and standards that have been developed for specific medical environments: ISO9001:2000 for activities involving research, ISO17025:2005 for diagnostic purpose, and GMP/FDA-compliant certification for therapy. In this way, a comprehensive center for the preservation of biological samples (vaccines, bone marrow, culture collections, DNA, microbial, and viral seed stocks) can manage resources and no-core functions, providing specialized outsourcing facilities that are recognized by an official organization. ¹⁰

Biobanking entails long-term financial resources, a strategic location, ongoing validation, expert management, qualified employees, investment technology, and a deep understanding of the worldwide industry regulations and continuously updated contingency plans. By outsourcing such complex and specialized functions, biopharmaceutical companies can allocate their resources and capital toward drug development, which is their primary mission.

Escalating and costly industry regulations regarding audit trails, reporting requirements and handling procedures will likely increase the frequency of outsourcing storage operations.

As a guide, at least 180 disease-biobanks exist in the United States and over 200 establishments are currently licensed to operate in Europe, most of which were established in the last 10 years. ¹¹ These evidences indicate that specialized external facilities are a true alternative and not only a perspective.