Stability in Biopharmaceutical Storage - Patrick Jackson of Vindon Scientific offers key considerations for choosing an outsourced sample storage facility. - BioPharm International

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Stability in Biopharmaceutical Storage
Patrick Jackson of Vindon Scientific offers key considerations for choosing an outsourced sample storage facility.

BioPharm International
Volume 25, Issue 11, pp. 45-47

SAFE STORAGE

The storage of cells at temperatures below minus 150 șC is necessary to preserve materials unaltered. This is the point at which biological activity ceases. Although mechanical devices can be used to maintain temperatures below this level, they can be noisy and generate heat. They also require liquid nitrogen backup to avert disaster should the electricity supply be disrupted or the freezer fail. Liquid nitrogen is the most logical choice for storage at temperatures below minus 130 șC. But there are risks associated with its use. To ensure there can be no cross-contamination with the stored samples, it is generally recommended that materials are stored in the vapour phase above the actual nitrogen, where temperatures are in the region of minus 150 șC down to minus 178 șC.

An efficient cryobank should provide a management solution for short-term, medium-term, and long-term temperature controlled storage. It should incorporate secure storage and real-time tracking of the stored samples and all safety issues should be in strict accordance with the latest regulations. It is also essential that sites have the staff and systems to offer foolproof biological storage conditions. A purpose-built state-of-the-art biorepository should accommodate biological samples, culture collections, microbial, viral seed stocks, DNA and bone marrow, as well as all-important stem cells and cord-stem tissue.

Stem-cell and cord-blood storage

Stem-cell research is a market that is in its infancy, but there is little doubt that frozen sperm, eggs, embryos, and stem cells being stored at clinics and hospitals will eventually become the norm across the world. A good storage company should already be constructing cryobanks to satisfy the needs of this emerging market. In the United Kingdom, cord blood has become the most frequent source of stem cells for transplantation in children. It is estimated that by the year 2015, there will be up to 10,000 cord- blood transplants worldwide per year, using banked cord blood. A vital aspect of this program will be to develop repositories for the storage of cells to guarantee continued successes in this exciting arena.

Long-term storage

There are some finely tuned methods of preserving biological materials by freezing and storing them at ultra-low temperatures. The provision of long-term preservation of biologics, reagents and specimens is often required, together with a secure facility for samples and laboratory research materials. Ideally this should cater for anything from a single box of samples, up to virtually any volume, for the duration of any research project and be capable of storing millions of samples, vials or tube racks.

VALIDATION

A comprehensive storage facility should have full regulatory compliance to guarantee the integrity of the samples it stores. They should have the latest equipment to ensure that the facility is technically fit for purpose, meets the highest standards of environmental control, and includes built-in redundancy and emergency backup. Every piece of equipment should also be protected by an individual preventative maintenance schedule.

Constant monitoring is normally performed with a paperless data logging system that, ideally, should also be compliant with the requirements of the US Code of Federal Regulations. An ultra-low temperature storage facility of minus 70 șC to minus 85 șC can be tailored to the needs of biotechnology, pharmaceutical, and agrochemicals companies, including veterinary industries and academic institutes.

Expertise in sample management underpins the secure storage of samples and should include constant monitoring of the storage conditions, the ability to track and retrieve samples to GLP standards, and full traceability in regulated environments.

Validation must be carried out regularly to ensure that an environmental room, cabinet, or cryogenic freezer is capable of accurate and repeatable performance. Temperature and humidity levels should be monitored at all times to incorporate an identifiable audit trail.

SAMPLE TRACKING

Managing hundreds of thousands of samples for different companies, with dissimilar protocols, requires an efficient sample tracking system to ensure that they are all handled properly. When samples are outsourced properly, identification of each sample is needed to prevent confusion when removing the samples from chambers. Samples should be clearly labeled, typically with quantity, storage conditions, product name, product code, lot number, and date of manufacture. Reliable software can also make a significant difference when tracking pull dates, sample locations, and quantities.

A comprehensive information management system is at the heart of all storage solutions. The inventory management solution should enable the user to record all data associated with the samples including location, temperature, and humidity, as well as recording all user-defined information. Every sample handled should ideally be given a unique barcode label and be recorded on the system. This system significantly simplifies handling, tracking, and processing. Supplementary information relating to individual samples in terms of movement within the facility, time, and duration of storage vessel openings and who accessed the vessel must also be available within the audit trail.

DISASTER RECOVERY PLAN

The outsourced storage facility should provide secure secondary storage as an essential insurance policy. A third party should retain duplicate samples in a different but secure second geographical location. This step can help to eliminate the risk of a disaster scenario destroying valuable stability storage samples and causing commercial damage.

COST CONSIDERATIONS

All this expertise can come at an affordable price, usually levied as a standard monthly or annual fee, but charges for set-up, transactions, or removing samples should not be extra. The controlled-environment facility should offer a simple cost-effective arrangement for a precise and intricately managed service.

CONCLUSIONS

Controlled-environment storage is a demanding business. It presents many challenges including high costs, management expertise, and regulatory procedures. The decision to outsource will depend on a company's current resources and future needs. Outsourcing provides qualified and knowledgeable staff that will keep abreast of topical developments, offering unique conditions with state-of-the-art facilities to match. Outsourcing is the logical choice to navigate through the maze of equipment, technologies, controls, and procedures that lay ahead.

Choose carefully, and a strategy can be developed that is not only tailored to a specific organization, creates and maintains a successful and trustworthy relationship for every program.

Patrick Jackson is business development director at Vindon Scientific Limited.

REFERENCE

1. ICH, Q1A (R2), Stability Testing of New Drug Substances and Products (Aug. 2003).


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