The bioactivity acceptance criteria listed on your product data sheet is higher than what others have on their website. Why is it so different?
Shenandoah is taking steps to offer our customers 100% transparency with our QA. One of these steps is to list the minimum acceptance criteria so that our customers can be assured of the quality they are purchasing. Shenandoah’s acceptance criteria is set using internal bioassay data in combination with self-reported “typical” ranges and acceptance criteria of our competitors. It is important to note when comparing the two, a “typical” range and an acceptance criteria limit are not equal. Shenandoah’s results are most often much lower than the acceptance criteria set. When this is the case, the “typical expected range” will be published on our website as well.
Your datasheet states the biological activity as an ED50. What is the Specific Activity?
The ED50 is an expression of activity at 50% of its maximum response. Specific activity is just another way of conveying the activity of the protein. To calculate a specific activity, divide 1 x 10^6 by the ED50 in ng/ml.
Specific Activity (Units/mg) = 1 x 10^6 / ED50 (ng/ml)
For some proteins (mainly viral CPE assays), the specific activity is the only number calculated. For other assays that are more qualitative in nature (chemotaxis and western blotting for phospho-proteins), specific activity is not a relavant way of communicating activity.
Is specific activity reported in units/mg the same as International Units (IU/mg)?
No. International Units are calculated using a validated assay where the cytokine in question is tested side-by-side with an internal standard set by the WHO. The activity of the cytokine in question is then normalized to the activity level of the standard.
Select cytokines are run side-by-side with an international standard (IS) and this data is indicated for each of these products.
Products tested against IS:
For those products that are not compared to IS, the data reported on our documents are considered “in-house-units” and are routinely run side-by-side with competitors from the recombinant protein market, but cannot be compared to other assays directly. Even if the same cell line is used, there are still factors that will differ from lab to lab, and comparability of results can vary.
I want to try to do an experiment with your protein, but the bioassay you use for determining activity is not the same as my application. Will my application work with your protein?
Our products are used for many different purposes, so it would be impossible to predict every possible application. Our standard bioassay is used to confirm an accepted activity level for the product. Our proteins can be used at a broad concentration range, in many different applications, thus, it is the end user’s responsibility to determine the concentrations that work best for their specific assays.
Do most proteins show cross-species activity?
Although many human cytokines will respond nicely in mouse cell lines, and many mouse proteins will show activity on human cells, species cross-reactivity must be investigated individually for each product.