What is it? Why is it important?

Biological Material (BM) is a chemical substance present or produced in a living organism.

It includes any organic matter or biologically active compound from animals, plants, or microorganism, such as:

  • Body fluids: any liquid originating from the body of humans and animals (e.g. blood, serum, urine, saliva, liquor, semen)
  • Tissue: a cellular organisation intermediate between cells and a complete organ (e.g. a biopsy during surgery)
  • Cellular component: material and substances making up a cell (e.g. DNA/RNA, proteins, peptides, enzymes)
  • Organic matter: originating from a once-living organism (hair, nails)
  • Viable material: capable of living, developing, or germinating under favourable conditions (e.g. viral vectors, bacteria, plant seeds)

What do I need to do?

Make yourself familiar with the term “Biological Materials” which also includes all of the following:

  • Recombinant or synthetic DNA/RNA (plasmids, cloned materials, oligonucleotides, siRNA)
  • Viral vectors (e.g., lentivirus, retrovirus, adenovirus)
  • Genetically-modified organisms (animals, microorganisms, plants, insects, cells/cell lines)
  • Living animals, animal carcasses, or animal products including tissues, cells, blood, or other bodily fluids
  • Pathogenic microorganisms, including human, animal, or plant pathogens
  • Plants, animals, insects, microorganisms, or cells that produce toxic compounds
  • Toxins of biological origin (e.g. cells, DNA/RNA, proteins, enzymes, including a combinations thereof)

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

SBP Documents

SOPs, Forms and Templates – see in particular

  • Biological material management SOP


ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular section

  • 3.7 Definition biological material
  • BM – Biological Material
  • DNA – Deoxyribonucleic Acid
  • ISO – International Standards Organization
  • RNA – Ribonucleic Acid
  • SBP – Swiss Biobanking Platform
  • siRNA – small interfering Ribonucleic Acid
  • SOP – Standard Operating Procedures
Basic ↦ Biobanking ↦ Definition ↦ Biological Material

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Biobanking ↦ Definition ↦ Biological Material

Please note: the Easy-GCS tool is currently under construction.