Pharma Manufacturing: 6 Questions to Ask When Vetting Serum Suppliers | Corning

Endotoxin levels and hemoglobin levels are among the best indicators of the quality and cleanliness of a supplier's sera collection process. The lower the levels, the better.

"Endotoxin is always a huge consideration and may be a measure of poor quality and handling," Koza said. "As is hemoglobin: If you have a high hemoglobin level, you're seeing more lysing of red blood cells during the separation process, indicative of less-than-ideal processing conditions."

2. What kind of lot-to-lot variability should I expect in the sera?

With an animal product, such as fetal bovine serum, there's going to be variability between lots, but the extent of variability can differ from supplier to supplier — sometimes it's just a little, but sometimes it's a lot. Typically, bigger suppliers offer more consistency, Koza says.

Ask your supplier what kind of variability you should expect, and request samples to screen new batches against the performance of existing lots.

"When you receive two different lots of the same material, each can behave very differently," Koza said. "Performing lot evaluations before purchasing can go a long way in matching expectations with desired outcomes."

After the lab closures and funding cuts of 2020, money is tight at many labs. But if you're tempted to buy sera based solely on price, remember that you get what you pay for — and the best deals don't always yield quality products.

"Purchasers who make cost their sole determination should be careful because they might not know where that serum came from," Koza said. "Not every company has a completely traceable supply chain, and the last thing anyone wants is to buy serum without having confidence in the source."

If you need budget-friendly options but don't want to sacrifice quality, ask how the supplier can work within your financial constraints. You never know what kinds of discounts may be available.

The pandemic has affected the serum industry in several ways, but one of the most significant effects has been seen at abattoirs. Early in the pandemic, outbreaks at meatpacking facilities resulted in significant slowdowns or halts in production. Now that appropriate safety measures have been put in place, the supply has resumed.

Check with suppliers about these and other potential impacts of the pandemic, but, in particular, look for vendors that have what Koza calls "supply chain insurance." Some suppliers have direct relationships with meatpackers; others obtain their supply through intermediaries. Having a supplier with a direct relationship can make all the difference in volatile times like today.

Different suppliers have different serum production models. Some suppliers are simply finished goods resellers.  Others 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 lab bench.

The latter is ideal, so look for suppliers with a more integrated model.  Vertically aligned vendors like Corning can more readily verify every aspect of the final product.

The International Serum Industry Association (ISIA) traceability certification is a must-have. The ISIA works to harmonize technical standards, enforce ethical behavior, and educate the life sciences industry on the benefits of 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," said Koza, who sits on the ISIA's traceability committee. "It's 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."

Corning also holds Certificates of Suitability (CEP) from the European Directorate for the Quality of Medicines (EDQM) on several of our sera products. For therapeutics sold in Europe, the CEP is critical as it ensures the serum product and process meet the European Pharmacopeia (EP) criteria for minimizing the risk of bovine spongiform encephalopathy (BSE), better known as the cause of mad cow disease.