As a laboratory that deals in a specific science, you're perhaps starting to realize it's impossible to do testing on your own without some help. Whether its histology, biotechnology, or the pharma industry, your reputation is on the line if a particular study goes awry due to staff inefficiencies.
In the role specimen storage plays in GLP preclinical studies, there is a simple answer; it is at the heart of pharmaceutical research and important to Food and Drug Administration approval for new drugs. However, that statement does need extensive qualification.
Specimen Storage: Why FM-200 is the Best Fire Suppression System
Maintaining integrity at each step in the life cycle of your study materials is the primary responsibility of a contract specimen storage facility. This includes controlling conditions, auditing the facility for GLP preparedness, safeguarding the inventory and offering transparency at every point throughout collection, transport, processing, storage, retrieval and disposal of study materials. A quality facility will work with you to establish the most appropriate storage solutions for your particular needs and plan accordingly to ensure those requirements are achieved. Comprehensive biospecimen storage and management requires that the following considerations be guaranteed.
Market demand for outsourced preclinical research services is growing. Pharmaceutical and biotech companies need contract research organization (CRO) partners who can help them maximize productivity and efficiency in research and development. Faced with a variety of cost pressures, such as patent expiries and more competition from generics, pharmaceutical companies are building strategic relationships with CROs at an increasing rate.
Contract Research Organizations, biorepositories, and researchers globally store billions of specimens such as tissues, plasma, urine and other fluids for future use. In order to preserve the integrity of these samples, they must be collected and stored under optimal conditions. While storing biospecimens at −20°C has been a common practice, samples for long-term storage are increasingly being kept in ultralow temperatures ranging from −70°C and −80°C to prevent sample degradation.
Preclinical research studies generating data for submission to the Food and Drug Administration (FDA) must adhere to Good Laboratory Practices (GLPs). These practices embody a set of principles that guide how laboratories plan, perform, monitor, document and archive study activities in an effort to enhance the quality and validity of test data. Below, you’ll find some practical tips on finding the right archiving facility for the long term storage of your study materials:
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