I heard previously there have been so-called FDA-certified serum lots that are good for GMP clinical applications. Is this info correct? If so, where can I find related ordering info? In addition, what are the differences, in terms of serum quality and/or analytical testing, between FDA-certified vs. “regular” serum we buy for routine lab use? Is there an increased risk of adventitous contaminants with regular off-the-shelf serum if not FDA-certified?

Answer

To my knowledge, there is no animal serum product approved by an entity such as the FDA.Sera products from the larger suppliers are generally manufactured in facilities compliant with GMPs and ISO standards. Manufacturers may also conform to other international quality standards. Each manufacturer generally with have product lines offering a variety of testing levels. A review of the specification and/or C of A prior to any purchase is a key activity to ensure the product is suitable for the intended application. Definitely work with the manufacturer to obtain the information needed to make the right purchase. They can inform you of product label claims, compliance to quality standards, testing and origin of the products.