Comprehensive outsourcing biobanking facility to serve the international research community.

Abstract

The validity of results from biomarker studies using archived specimens depends on the integrity of the specimens and the manner in which they are collected, processed, and stored. The management of a huge amount of biomaterial generated from research studies and clinical trials is becoming a very demanding task and many organizations are facing the choice between in-house storage and processing and outsourcing some activities. Storage and logistic functions are the prime targets for outsourcing, because to sustain these critical assets organizations must have the expertise, the dedicated qualified personnel, the proper quality control programs, and available resources to fulfill the mandatory requirements to maintain the integrity of the samples. External biobanks are dedicated and certified infrastructures (ISO, GMP, etc.) that apply efficient logistic and shipping activities, use validated standard operating procedures, install appropriate monitoring back-up systems, and, most of all, have room for expansion. Thus, the choice between in-house biobanking and outsourcing cannot be exclusively based on a financial decision; it must also consider (i) type of collection/project, (ii) logistic complexity (number and locations of collection sites), (iii) safety requirements, (iv) functional expertise, and (v) business priorities.