Good Storage Practices

The importance of managing the storage and transportation of clinical trial samples.
Jan 01, 2010
By Applied Clinical Trials Editors

The pharmaceutical industry's recent shift of focus to molecular therapies, genomics, and biomarker discoveries in medical research has increased the need for well-preserved biological samples. This has created substantial value for samples derived from clinical research.

Today, high-quality tissue, blood, and serum samples derived from clinical trial patients can be used to advance a wide range of medical endeavors. As such, preserving samples to the highest standards has become a critical component in maximizing the value of present day and future clinical research.

Critical responsibility

By utilizing today's high-throughput analytical and molecular technology, quality biospecimens are used to detect biomarkers, identify new applications for existing targeted treatments, accelerate drug development, and create biomarker-targeted diagnostics and therapeutics. Temperature control and monitoring during the storage and transportation ensures the efficacy of samples for future analyses.

To ensure the integrity and long-term viability of clinical samples, pharma and biotech companies will need to develop strategies for the specialized storage and transportation of these samples. Without careful consideration for compliant storage, shipping, data management, and audit trails, researchers risk damaging or losing clinical research samples. This, in turn, has serious time and financial implications on the clinical trial process.

Consider the consequences if clinical trial samples were to thaw out before reaching the testing lab, rendering the samples useless. This compromise could cost the sponsor hundreds of thousands of dollars to repeat the trial. Moreover, if samples are delayed at customs and don't reach their destinations on time, it could have a ripple effect on the development process by increasing the time it takes to bring a new product to market. This could consequently cost the sponsor millions of dollars, as a day lost in development is a day lost on the market.

Furthermore, regulatory agencies increasingly require more detailed information for the approval of new drugs. A complete audit trail detailing the sample's history from collection to destruction protects sponsors from clinical trial setbacks that could postpone product launch.

A lack of planning can prove costly, as these materials represent today's multimillion dollar research investments and tomorrow's multibillion dollar revenue. By developing a strategic sample management plan that takes into account best practices for temperature-controlled storage and logistics, regulatory guidelines, and audit trails, organizations can protect financial investments while streamlining the research processes.

Good storage practices

Similar to other GXP environments, good storage practices require the discipline and attention to critical details, such as regulatory and industry compliance, data management, and quality and risk management. Good storage practices should be described in Standard Operating Procedures (SOPs) to ensure that processes are widely recognized and constantly met by personnel. These SOPs should be incorporated into routine training programs, and should be regularly updated to guarantee compliance to an expanding array of regulatory requirements from a number of entities.

The U.S. FDA, the Centers for Disease Control, and professional organizations such as the American Association of Tissue Banks, the National Cancer Institute, the American Association of Blood Banks, the International Red Cross, and the International Society for Biological Repositories provide guidelines for biorepositories and human sample banks. Without SOPs that take into consideration these guidelines, staff turnover may jeopardize sample integrity through loss of knowledge that occurs when an employee leaves an organization.

Additionally, other factors to incorporate into good storage practices include:

  • Secure facilities and redundant measures to ensure specimens are kept in compliant conditions at all times when in storage
  • Expert staff that has been trained specifically in sample storage and transportation to ensure all regulatory and custom issues are properly handled
  • Storage technologies capable of monitoring the temperature of samples around the clock in order to provide a complete audit trail
  • Business continuity plans and redundant systems to protect sample integrity during emergencies.

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