Fetal Bovine Serum (FBS): Past - Present - Future

Area of Science:

• Cell Biology
• Biotechnology
• Regulatory Science

Background:

• Fetal Bovine Serum (FBS) is widely used in cell culture but presents issues with quality, reproducibility, animal welfare, and ethical concerns.
• The scientific community is actively seeking alternatives and developing serum-free media formulations due to these disadvantages and recent fraudulent marketing cases.

Purpose of the Study:

• To discuss regulatory aspects, the challenges of using FBS, and explore alternatives and serum-free media.
• To review case studies of serum-free applications and the establishment of serum-free databases.
• To address the ethical and practical dilemmas surrounding FBS use in scientific research.

Main Methods:

• The report summarizes discussions from the 3rd Workshop on FBS, Serum Alternatives and Serum-free Media.
• It covers regulatory frameworks, ethical considerations, and scientific strategies for FBS reduction or replacement.
• Case studies and new developments in cell-based assays, organ-on-chip, and microphysiological systems were presented.

Main Results:

• The ethical and regulatory vacuum surrounding FBS procurement was highlighted, despite existing EU directives.
• Human platelet lysates are identified as a promising alternative to FBS when chemically-defined media are not feasible.
• Advancements in cell-based assays and organ-on-chip technologies are enabling wider adoption of serum-free systems.

Conclusions:

• Serum-free media, particularly chemically-defined formulations, represent the ultimate goal for most cell culture systems.
• Strategies for FBS reduction and replacement, including human platelet lysates, are crucial for advancing cell culture research.
• Addressing the regulatory and ethical aspects of FBS is essential for sustainable and reproducible scientific practices.