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•Feature Article: The Case for "Good Storage Practice" In Biopharmaceutical Development

By F. John Mills, Oscar Moralez, and Jennifer Benner

Those working in medical research and drug development have always needed to store biological materials such as blood samples and active pharmaceutical ingredients. Stored biomaterials can be used for a number of purposes, from medical education to examination of disease processes over time. The biopharmaceutical industry specifically offers many compelling reasons to store samples derived from clinical research, all of which are potentially critical to commercial, scientific, and medico-legal issues in drug development.

Despite sophisticated protocols that delineate all aspects of drug development, companies often overlook the critical step of developing strategies for specialized, long-term storage of biological samples. Because of the intrinsic value represented by such samples, this represents a significant missed opportunity for many businesses. Biotechnology and pharmaceutical companies, large and small, must take seriously the need to develop such strategies to help such organizations reduce drug development times, develop new therapies and drugs, react quickly to unexpected adverse reactions, and identify new diagnostic assay techniques or biological markers. A carefully planned sample management strategy and practice will address areas such as biosafety; centralization; cold chain logistics and management expertise; compliance; information management and audit trails; scalable, standardized sample storage; and standardization. These functions can be managed in-house or outsourced to dedicated cold-chain–logistics and storage experts.

Reprinted with permission from BioProcess International. (October 2006)

Click Here To Download:
•Feature Article: The Case for "Good Storage Practice" In Biopharmaceutical Development