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The biorepository: The cornerstone of drug development
November 2011
SHARING OPTIONS:
Properly managing biospecimens and their associated data has
become an increasingly important component of today's drug development and
discovery
process. Today, biomaterials such as whole blood, human tissue, DNA
and RNA serve as the foundation for translational research that holds the
promise
of bringing personalized therapeutics from bench to bedside. These
materials are being leveraged by organizations around the world as the basis
for
biomarker programs, which can give researchers insight into predicting
future patterns of disease.
By incorporating biospecimen and biomarker components into
discovery initiatives, researchers can incorporate information about cell
biology and
its impact on treatment options and patient prognosis. Through this
new understanding, novel treatment options may be developed to target specific
pathways for all manners of diseases such as cancer and Alzheimer's. Biomarker
assays may also help identify patients with specific mutations or
abnormal
protein expression in certain cell pathways, allowing for individualization of
therapies addressing specific abnormalities.
Given the intrinsic value of these materials, preserving
specimens to the highest of standards is critical, not
only from an operational
and scientific perspective, but also from a regulatory and financial
standpoint. As a result, it has become critical for
biotechnology and
pharmaceutical companies of all sizes to have a profound understanding of
sample management strategies, and biorepository operations
that help ensure the
long-term preservation of biospecimen samples. Here, we outline preparation
techniques, best practices for sample storage and
transportation, and explain
how information systems can enhance global biorepository operations and help
optimize biospecimen integrity.
Pre-analytical variables introduced during clinical sample
collection and processing significantly impact the molecular
integrity of
specimens and bias the results of assays and/or biomarker studies. Therefore,
an essential component of any sample management strategy is
a set of
standardized protocols for sample preparation techniques.
Inexact sample
preparation can lead to sample loss,
reprocessing or complicated data interpretation. For example, to prevent
degradation of RNA and DNA, stabilize the
matrix (e.g., with alcohol)
immediately upon collection. After the matrix has been stabilized, store it at
the proper temperature without temperature
excursions.
Compartmentalized
storage equipment, continuous temperature monitoring and redundant power
sources are
essential. Furthermore, because modern assay technology requires
very small volumes for most tests, it could be useful to divide biospecimen
samples
into multiple controlled-volume vessels.
To ensure biospecimens are properly handled, transported and
stored, many drug developers and research organizations are aware of and adhere
to Good Storage Practices (GSP) guidelines. While GSP is not a
regulatory
mandated requirement, the International Society of Biological and Environmental
Repositories (ISBER) as well as governmental organizations
like the U.S.
National Cancer Institute (NCI) have established specific good storage
practices guidelines.
Factors that should be considered in defining sound storage
practices include:
Cold chain logistics
and management
Cold chain
management defines how temperature-sensitive
materials such as biospecimens, study drugs and active pharmaceutical
ingredients are packaged,
transported and stored throughout the research and
development process. Weakness or failure at any point in the chain can
compromise product integrity,
breach security, delay shipments and ultimately
result in financial loss or liability.
To ensure compliance and optimize the
biomaterial cold
chain, organizations should take a holistic approach to cold chain management
in which processes are an integrated component of the
organization's overall
best practices.
Information and data
management for global sample inventories
While proper
storage and transportation are critical,
samples are useless unless they can be located with their associated data, in a
timely fashion. In the past,
researchers applied ad-hoc tracking systems such as spreadsheets to track and plot
information associated with biospecimens. Today, the
complexity of clinical
trial research has rendered these outdated and archaic systems inefficient to
handle expanding biospecimen inventories. The
ideal system should offer
tracking and reporting processes through all stages of a sample's shipping,
handling and storage lifecycle.
Because pharmaceutical and biotech labs typically implement
a wide range of information systems, sample
management systems should
seamlessly interface with other systems, provide global data integration and
access, and be highly configurable to easily
integrate with a variety of
laboratory workflow models. The integration of sample storage, consent
authorization and clinical result data is another
area of expansion occurring
due to the advent of new technology systems. Connecting information on sample
storage location, temperature and pre-testing
evaluation with the resulting
data from a clinical study can enable researchers to improve their selection of
samples for biomarker testing while
shortening development timelines.
The growing role of
outsourcing in
global sample management
Organizations initiating a sample management
strategy have a
number of options when deciding where and how to store their specimen
inventories, including storing on-site, off-site or both.
However, due to the
exponential amount of biospecimen samples generated during clinical research
and the complexity of handling and transporting these
temperature-sensitive
materials across international borders, it has become commonplace for
organizations to outsource their biorepository operations
to specialized
providers.
Central laboratories that test blood and
tissue samples
sometimes offer storage as an ancillary service. However, given the increased
value gained over many years of storage, it is essential
that biorepository
facilities be optimized for reliable, long-term storage and information
management. Specialized biorepository vendors may provide
services such as
automated sample tracking and reporting, fully verifiable audit trails;
extraction of nucleic acid; verification of DNA purity, yield
and
concentration; and volumetric and normalized aliquoting. These services allow
researchers to customize various quantities of samples from a given
subset of
subjects into the sample size and tubes required for testing.
As cost concerns and risk
management continue to be critical
factors, companies are increasingly establishing hybrid approaches to on-site sample
management where inventories
are stored on-site, but are dictated by standard
operating procedures and technology provided by an outsourced provider. This
allows for the
appropriate tracking, assigning and processing of individual
samples across multiple studies on a routine basis. Additionally, it leads to
more
efficient lab processes, given that most services that require automation
are assigned to specimens across studies.
The industry recognizes the one-size-fits-all approach to
drug development is no
longer the pathway to success. Today, the industry is
focused on a more targeted approach to drug development, where the right
treatment is prescribed
to the right person, at the right time. As personalized
medicine and genomic-based therapies become the gold standard in drug
discovery, specimens such
as blood, serum and tissue may hold the key to better
understanding some of the world's most devastating diseases. With this in mind,
now is the time
for pharmaceutical and biotech companies, both large and small,
to assess their current sample management strategies to ensure current and
future drug
discovery is not jeopardized by sub-optimal management processes or
samples or lack of sample data.
Gregory
Swanberg is
CEO of BioStorage Technologies in Indianapolis. He has
provided management and
consulting support, both domestically and globally, to companies including
Pfizer Inc., Merck & Co. Inc., Genentech Inc., Novartis AG, Eli Lilly &
Co. Inc., Morgan Stanley, AT&T, Whirlpool and Lexmark. Swanberg holds a
bachelor's degree from the University of Kentucky, a master's degree in public
administration
from Georgia Southern University and a master's degree in
business administration from Northwestern's Kellogg
Graduate School of
Management. Back |
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