Monday, August 13, 2012

Meeting the Specimen Management Needs of the Small Biotech Industry

Today's guest post comes from Feridoun Karimi-Busheri, Director–Stem Cells, NovaRx Corporation.  It is also co-written by Steve Moses, VP of Technical Operations, NovaRx Corporation. He will be presenting "Avoid the Risk of Damage to Cancer Cell Utility After Freezing" at the 5th Annual Biorepositories and Sample Management Conference taking place September 19-20, 2012 as a part of the Clinical Business Expo.  If you'd like to join Karimi-Busheri, register today and mention code XP1725BLOG and save 25% off the standard rate!

1. Please provide a brief introduction to the work that you do – and, specifically, how it depends on access to biospecimens.
At NovaRx Corporation I am in charge of the Stem Cell Department. My group is involved in finding novel therapies targeting cancer stem cells in solid tumor cancers. A major part of our research is focused on gene modification of cancer stem cells and using the modified cells sensitive to conventional therapies and natural immune system of the body. As a result, cell therapy and access to biospecimen plays a major role in our strategic plan.

2. NovaRx Corporation is developing a cell-based vaccine for lung cancer. Do you encounter extra challenges in guaranteeing that the banked cell lines you work with have been properly labeled and identified? If so, what specimen management and tracking steps have you tried to overcome this problem?
Banked cells at various points in development have been cataloged both electronically and in bound paper notebooks. Additionally as vials have been removed for use or for transport to off-site storage that information has also been cataloged in the freezer log. All frozen specimens are monitored by use of an alarmed 24/7 temperature monitoring system. As the number of samples being managed remains limited (under 100,000) this manual has remained adequate. A more automated (4D barcode) system is being planned and will be implemented in the near future as the number of samples stored on-site as well as off-site would be expected to increase significantly.

3. As a relatively smaller and newer company, how did NovaRx Corporation determine the balance of in-house versus outsourced specimen handling responsibilities? Did you contribute to that decision making process, and, if so, what were the most important criteria that you looked for in determining what tasks the company could handle internally versus those that had to be vendor-driven? What are the features that you look at in selecting, validating, and overseeing your specimen-related vendors?
NovaRx's current philosophy is to manage most of these tasks on an in-house basis. The outside storage of specimens which would need to be processed at NovaRx amounts to adding an extra handling and shipping step, creating the opportunity for mishandling or a misdirected shipment which would result in the loss of an irreplaceable specimen. Samples or specimens which may never be processed – such as duplicates and retention samples – would be packaged and moved to an off-site storage vendor. That vendor would need to meet the same criteria which NovaRx employs internally, such as: to track and safeguard stored specimens, a tracking system to prevent specimen mix-up; a system to ensure samples are not exposed to inappropriate environmental conditions; a high quality freezing system; and finally, having a suitable Quality System in place with documented employee training, such as a developed CAPA system and reporting procedures for process failures.

4. In your experience, how do the specimen handling and specimen research operational needs of a biotech company differ from those in an academic setting?
The record keeping and reverse traceability requirements are significantly more stringent in a commercial Bio-banking setting.

5. What would you most want to learn about biobanking in a live-conference format?
Mostly I would like to learn about what Quality Systems these vendors have in place to ensure the safety of samples we might store with them and how they address the concerns mentioned in earlier. As the shipping of specimens is particularly a cause for specimen damage or loss, it would be good to discuss packaging and shipping solutions they may offer for the various temperature ranges – such as room temperature, 2-8°C, -20°'C, dry ice, and LN2.

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