The right chromatography data system (CDS) ensures data quality and manages all the necessary processes along the analytical workflow, from instrument control to raw data storage and processing, right through to generating reports of the final results, allowing pharma and biopharma companies and contract research organizations to leverage their MS systems throughout various stages of research and product development, taking advantage of compliance-readiness when needed.
In this on-demand SelectScience® webinar, Dr. Dan Bach Kristensen, principal scientist at Danish clinical-stage antibody oncology-focused company, Symphogen, shares examples of how to boost productivity by using the right LC-MS software to streamline analytical workflows and enable the use of MS as a routine detector.
Read on for highlights from the live Q&A session or register to watch the webinar at a time that suits you.
Q: Will your system have a network transmission limit or issue by using Enterprise Chromeleon, as you have multi-HR mass instruments to generate and upload data?
DK: Yes, we tried to upload peptide map data to Chromeleon Enterprise. Each run is 1 to 1.5 gigabytes, and the system was not able to handle the upload a few years ago. Recently, we ran it again and now the Chromeleon Enterprise handles it well in a matter of seconds. I can ask the system to do an overlay of 21.2-gigabyte peptide map runs and it's a question of seconds before I get an overlay of the base peak chromatogram. I think an important aspect here is that you need to have sufficient hardware behind the cloud solution. As I mentioned, we have a dedicated vault server for each LC-MS system, so there is a lot of hardware muscle behind it and with that, it works really smoothly. Of course, if your network goes down, you will have issues. That's an issue for so many other aspects of our work.
Q: How long does it take to load and review TICs or BPCs for heavy MS data? For example, peptide map or MAM runs in Chromeleon?
DK: We have to manually import data from our Orbitrap fusion because it does not run under Chromeleon. That upload takes maybe one or two minutes per run, but once it's in the system, the loading of the base peak chromatograms or the total ion chromatograms, it’s very fast. I can do an overlay of 10, 20 runs in a matter of five seconds or so.
Q: Do you foresee continued growth in the number of MS methods and number of analyses in your lab in the coming years?
DK: Yes. One of the things I would like to look more into is performing structure-function studies with separation techniques based on affinity, hyphenated to MS. If you perform good chromatography with your immobilized antigen, and if you were able to resolve different populations of your drug chromatographically, that will allow you to do structure-function studies. Some of this has already been done, and there's some literature out there showing how different glycoforms bind with different affinity to the Fc receptors.
That being said, we already have a ton of separation techniques, and it takes time to switch from one separation technique to the other. At the end of the day, we're only the number of people we are, and we have the number of instruments we have. Therefore, we can't have an indefinite number of separation techniques. I would say we've found a sweet spot with techniques that are relevant in terms of which impurity methods we're using in the 2Z lab, because we can now get an MS readout for that in our characterization lab very efficiently with the setup we have.
Q: Do you only run MS to replace peptide mapping for evaluation of stability testing samples, or do you still run both intact MS and peptide mapping for the evaluation of stability testing samples?
DK: We do both. We always do intact maps first because it's very fast and efficient. At the end of the day, you need to map out exactly where a specific modification or product variant is located. For that, we use peptide mapping. But it's important to understand that peptide mapping is very labor intensive compared to the intact mass, and it is also a question of priority. We always start out with the intact mass, and then when we need to dig deep, we use peptide mapping.