Compendial endotoxin detection assays contain LAL lysate made from the blood of horseshoe crabs (Limulus polyphemus) which measures sample endotoxin potency. That measurement is based on correlating the sample response to an analyst prepared standard curve. The FDA requires that the lysate and endotoxin used for the standard curve be matched. This matching happens when the lysate/endotoxin combination is standardized against the USP Reference Standard Endotoxin (RSE). Any company purchasing an LAL assay must use matching reagents in order to be compliant.
A benefit to purchasing Lonza endotoxin detection assays is that for most of the assay kits, the matching lysate and control standard endotoxin (CSE) vials are contained inside the kit box. The associated Certificate of Analysis (CoA) contains the lot number of the vials, the reconstitution potency for the CSE, and is the link that demonstrates the vials are matched if questioned by an auditor.
As a member of Lonza’s Scientific Support Team, I often receive customer questions regarding the COA. For example, “Where can I find the CoA? It wasn’t in the kit box.” or “Why isn’t my COA coming up on the website?” are very common inquiries.
A few CoA points to consider:
- All Lonza CoAs can be found at our CoA webpage
- The key to searching for the kit’s CoA is to enter the kit catalog number and lot number – not the vial catalog number and lot number. While many times the vial CoA may be available, it will not contain the matching information needed to perform the assay. However, the kit’s CoA will contain this information.
- Save the printed CoA in a binder or save the CoA PDF to a desktop folder for easy viewing during an audit or when needed as a quick reference for performing the assay.
- Always reference the CoA prior to setting up the standard curve to ensure that the properly matched vials are being used for that test.
One final thought: if you ever have an issue accessing the Lonza website or cannot find the matching CoA, please contact scientific support for assistance!
You can reach Lonza scientific support using the regional e-mail adresses: US e-mail address or EU / international e-mail address.
Written by Travis
Scientific Support Specialist, Lonza Pharma-Bioscience Solutions at Lonza
