Four Key Considerations for Fetal Bovine Serum Sourcing

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Demand for serums to support the manufacture of biologicals had been surging even before the COVID-19 pandemic, but the pandemic further fueled the flames. Among them is the fetal bovine serum (FBS), a common component of animal cell culture media.

Fetal bovine serum is harvested from bovine fetuses taken from pregnant cows during slaughter. It is the most widely used serum supplement for the in vitro cell culture of eukaryotic cells. This is due to it having a very low level of antibodies and containing more growth factors, allowing for versatility in many different cell culture applications.

With constrained supply now affecting some of the biggest suppliers, manufacturers are looking at better verification of supply chain traceability, consistency, and quality. A vertically integrated supply chain supports a consistent, long-term stock for vaccine manufacturing and the manufacturing of other biologics.

To make sure that quality serum will be there when they need it, manufacturers need to observe the following key considerations when stocking or restocking their laboratory.

It is ideal for suppliers to have more integrated value chains, either sourcing bulk raw serum from intermediaries and contracting with partners for finishing or securing blood directly from abattoirs and proceeding in a fully integrated model from collection to the lab bench.

An example is Corning’s vertically integrated serum supply chain. From collection to scientist, it provides manufacturers with a consistent supply of FBS, even during times of regional supply constraints. Corning’s direct relationship with abattoirs ensures that collectors use our tools and training and adhere to strict aseptic techniques for blood collection at government-approved facilities.

It is important to have an International Serum Industry Association (ISIA) traceability certification. The ISIA works to harmonize technical standards, enforce ethical behavior, and educate the life sciences industry on the benefits of a serum. It conducts rigorous audits of companies’ entire supply chains before issuing traceability certification. It also publishes a list of the companies it certifies.

The ISIA ensures that you can discover information about where a bottle of serum originated. It is an extensive audit process that certifies an unbroken chain of custody through every stage of production, from origin to the end user. When a serum product has the ISIA seal of approval, it means that a customer can trust the source.

For therapeutics sold in Europe, the Certificates of Suitability are critical as it ensures the serum product and process meet the European Pharmacopeia criteria for minimizing the risk of bovine spongiform encephalopathy, better known as the cause of mad cow disease.

Traceability for biologics is critical to ensure that label descriptions are an accurate representation of product history and contents. As an animal-derived product, the exact composition of FBS is undefined and can vary between batches. Batch and lot variations can ultimately lead to experimental variability and limit inter-laboratory reproducibility.

Complete documentation ensures that both the customer and regulatory agencies can audit the processing of serum products and can uncover whether suppliers are engaging in serum pooling to offset local supplier cost fluctuations, a practice that can compromise performance.

A certificate of analysis for each lot detailing the serum’s lot, processing details, storage information, and test results should always be available upon request from the supplier.

Reputable suppliers will typically employ consensus testing methods specified by the serum industry to ensure that serum supplied to laboratories meets standards for levels of common contaminants that may impact its performance in cell culture, for example, endotoxin.

FBS contamination with endotoxin is a major concern to the pharmaceutical industry since endotoxins in vaccines and other cell-based parenteral drug products render them unfit for use. Endotoxins have also been shown in many cell culture experiments to affect cell growth and function as well as being a source of significant variability.

Testing of general serum properties and components such as hemoglobin is important to ensure performance. Hemoglobin in finished FBS is derived from the lyses of red blood cells during the transportation and processing of blood into the serum. When collection techniques were not as good, hemoglobin concentration was used as an indicator of the quality.

If your business is looking for a steady source of serum to help accelerate your journey from the bench to the production line and bring life-changing pharmaceuticals to market, DKSH and Corning offer a wide variety of FBS options to satisfy multiple applications from cell culture research to complete bioprocess production.

Reach out to us to learn more about our capabilities to help you produce consistent, reliable, and reproducible results.

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