5 Top Tips for Setting up Modern & Effective Global Biobanking Operations



Pharma IQ
07/15/2011

Biobanking holds an integral role within the pharmaceutical network, allowing better decisions on early drug development and improved outcomes.

As the industry becomes increasingly global, biobanking operations must ensure they maintain the high standards needed to provide high-quality biological samples and meet a set of tight and varied regulatory requirements.

1. Optimise your strategy for organising/maintaining a biorepository according to your needs

Biobanks created on a huge scale to deal with the future diagnosis and treatment of undefined chronic diseases are now sitting alongside those category-specific biorepositories being used for very targeted research purposes.

The strategy needed for organising and maintaining the UK Biobank, which contains blood, urine and saliva samples for long-term storage and analysis, will be different for that needed for the ARRA's Breast Cancer Family Registry biorepository.

The logistical challenge of organising and maintaining a biobank, which are sometimes overshadowed with talk of ethical and legal issues, should not be underestimated.

2. Defining a protocol that fits best for the scope of your project and budget

Protocol should be developed taking into account the samples which need to be collection, how these samples will then be processed and stored and how they will be kept to ensure their usefulness in the long term.

Interoperability and standardisation must be addressed with the choice of technology to support processing and storage of information, to ensure facilities are prepared for future developments in information sharing.

Studies should be undertaken to gauge the effectiveness of the protocol before it is implemented fully, like the steps undertaken for the UK Biobank project, however different protocols will be required depending on the scope and budget of any given project.

3. Observing variations in global regulatory environments

Guidelines on the ethical and social issues surrounding the process of biobanking have been published by Unesco, the Organisation of Economic Cooperation and Development the Council of Europe and the Organisation for European Cancer Institute.

In Europe, steps have been made towards harmonising the standards which cover the use of human samples and personal information. But global operations have to account for the regulations within multiple jurisdictions.

Nor is it just the regulation regarding the use of human samples which must be taken into account, data security breaches are increasingly being clamped down on by authorities and new storage facilities like the cloud present their own challenges in this area.

4. Maximising sample collection efficacy by working closely with legal and protocol details

Consent over use of samples is one of the key debates within biobanking circles, thanks to the different interpretations applied to the concept.

Researchers must balance their practical requirements with the inevitable ethical concerns which surround the use of biological samples. Considering these factors from the start will help maximise sample collection efficacy.

A lack of consistent operations protocols and surrounding the storage, documentation, processing and retrieval of biological samples also creates a barrier in accessing samples for organisations, like the United States' National Cancer Institute, and addressing these become more pertinent as biobanking crosses international boundaries.

5. Making your biorepository more useful to the end user and, ultimately, commercially successful

Biobanking must ultimately be accessible and of use to the end users if they are to prove successful and much of this is likely to be ingrained within the entire network of the biobank from its inception.

From establishing consent, to the collection of medical information, the choices made from the start will impact the uses it has for researchers.

In the future, international collaboration is likely to become a more dominant force in pharmaceutical research and calls are already being made for the infrastructure to be put in place to allow for the sharing of biospecimens between members of research disciplines.