The Impact of Foetal Bovine Serum in Bioprocess Technology
Introduction
Foetal bovine serum (FBS) is a crucial component in bioprocess technology, especially in biopharmaceutical manufacturing. A common belief is that FBS from regions like New Zealand is superior in quality compared to that from South America. While origin can influence the price, it does not affect the biological performance or quality of the serum. Instead, the health status of the geographical region and the regulatory infrastructure significantly impact its use, import availability and cost.
Health Status and Foetal Bovine Serum
The World Organisation for Animal Health (OIE) determines the health status of a country, providing transparency on global animal disease situations. This status, along with interagency government agreements, dictates where serum can be exported from and imported. Each country has different requirements based on the health status of the serum’s region of origin. These requirements are complex and constantly evolving, highlighting the importance of exporters contacting border inspection posts for current regulations before shipping FBS.
Geographical Origin and Importation of Foetal Bovine Serum
The geographical origin of FBS does not affect its ability to support cell growth. Instead, it influences the potential disease transmission risk. Table 1 from the Bioprocessing Journal article illustrates the complexity of FBS market access, showing the various importation requirements across different countries and regions. For example, the USA can import FBS from New Zealand, Australia and Mexico, among others, while the UK and European markets have their own set of stringent requirements.
Risk Mitigation for Foetal Bovine Serum
Although FBS from different countries supports cell growth equally well, the health status of the originating country can pose risks of disease transmission. To mitigate these risks, treatments such as filtration and gamma irradiation are employed. Filtration through 0.1-micron pore-size membranes can remove bacteria and mycoplasmas. Gamma irradiation, while complex, can reduce viral loads in serum. However, it is not uniformly effective against all virus types, particularly small non-enveloped viruses like parvoviruses and circoviruses.
Barrier-Free Trade Challenges in Foetal Bovine Serum
The serum industry aims to achieve barrier-free trade of serum collected under controlled methods from facilities where animals are slaughtered for human consumption. However, several factors hinder this goal:
- Ongoing Animal Health Monitoring: The OIE’s monitoring and suspension of regions during disease outbreaks.
- Limitations of Gamma Irradiation: Gamma irradiation’s inability to eliminate all potential disease risks.
- Political and Trade Agreements: International trade agreements and political pressures affecting meat exports impact serum trade.
Despite these challenges, the International Serum Industry Association (ISIA) works globally with regulators to clarify the actual risks versus perceived risks of disease transmission through blood-derived products. They advocate for scientific data to support the safe and free movement of FBS in the global economy. More information can be found on their website www.serumindustry.org
Conclusion
Understanding the broader regulatory and risk management landscape is essential in selecting and using FBS. By addressing these challenges through scientific research and regulatory cooperation, the bioprocessing industry can move towards a more harmonised and globally accessible market for FBS.
For more detailed insights, refer to the full open-access article by Jennifer A. Murray and Rosemary J. Versteegen in the Bioprocessing Journal.