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.
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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.
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
- Business continuity plans and redundant systems to protect sample integrity during emergencies.