When accurate analytical data aren't enough to solve the problem
Investigating unexpected elemental contamination with ICP-MS
Unexpected results are part of pharmaceutical development and manufacturing. But what happens when an investigation stalls despite reliable analytical data?
A change in cell culture performance, an unusual stability result or a deviation in an established process can all lead to investigations where the cause is difficult to identify. In such situations, knowing what to investigate can be just as challenging as carrying out the analyses themselves.
When reliable results leave questions unanswered
When elemental contamination is suspected, analytical teams typically start with the elements most likely to be involved, based on the product, the manufacturing process and known risks. This is a reasonable approach and, in many cases, provides the answers needed.
In other cases, the investigation makes little progress. The methods perform as expected and the results are scientifically sound, but the source of the problem remains unclear.
One possible explanation is that the elements being measured are not necessarily those contributing to the issue.
Are we investigating the right elements?
This is worth considering before investing further time and resources in targeted analytical work. Depending on the circumstances, looking beyond the initial selection of elements may help identify potential contributors that were not previously considered.
A rapid semi-quantitative ICP-MS screening method can provide a broader elemental profile help scientists focus their investigation on the elements that need further attention and to be quantify.
In our latest Analytical Perspective, we present the screening approach developed by our scientists to evaluate approximately 60 elements and support investigations into potential elemental contamination.
Analytical Perspective - When the root cause is hidden, start with the elements
Discover our rapid semi-quantitative ICP-MS screening approach, its applications in pharmaceutical development and manufacturing and how it helped guide a real client investigation.
