What are Biospecimens

A biospecimen is a sample of human tissue or biofluid – essentially any tissue or fluid that comes from a patient or healthy donor.

Why they are needed

Pharmaceutical, in vitro diagnostic, biotechnology, medical device companies, as well as academic researchers need biospecimens in order to develop our medications, treatments, and medical devices. This is to develop our diagnostic tests, medical devices, medications, and treatments.

Where they come from

Biospecimens are collected as part of routine Standard of Care (SOC), or for a specific ethically-approved scientific purpose.

• Routine Standard of Care: Samples may be collected from a person undergoing a routine diagnostic test (surplus or clinical remnants).
• Specific scientific purpose: Scientific companies are always performing Research & Development to improve some aspect of patient care and clinical outcome, and as such they often need to partner with clinical organizations to collect specific samples.

Biospecimens are precious gifts contributed by numerous anonymous donors throughout the world to advance science and diagnosis or to treat diseases.

Biospecimens are often stored for future research

While some biospecimen are discarded after a medical encounter, some have the patient’s consent to be stored for use in future research. They may be stored in:

• Laboratories
• Hospital or academic biobanks
• Commercial biorepositories

How researchers obtain biospecimens

Supply-side: Clinical or diagnostic or academic facilities can be Providers of biospecimens. Providers may sometimes be aggregated by a Site Management Organization or Aggregator.

Demand-side: R&D teams at biopharma and diagnostic companies can be End Users of biospecimens.

Professional Services Organizations: (like Specimen Bio)

Intermediaries / Brokers / Traders: Organizations or individuals who first procure and then offer biospecimen to end users.

Technology Platforms / Marketplaces: Internet-based organizations that automate or improve some part of the biospecimen procurement process.

Archivers: Organizations that may store post-care or post-clinical trial samples to satisfy their clients’ regulatory requirements

Processors: Organizations that analyze, preserve, fractionate, etc biospecimens prior to end use (e.g. PBMCs).

Conditions for the usage of biospecimen

• Must be obtained with appropriate Ethics Approval (or valid Waiver)
• Must be obtained with appropriate Donor Consent (or valid Waiver)
• Must respect the WMA Declaration of Helsinki
• May sometimes require Material Transfer Agreements governing for what purposes, where, and by whom, the biospecimen can be used.
• Must be transported appropriately, usually by specialized couriers, given the nature or physical aspects of the biospecimen (eg. infectious; eg. fresh; eg. deep freeze)