Name: Jasmine Mace
Alcami Site: Germantown, WI
How long have you been with Alcami?
I have been with Alcami since March 2014.
What is your role?
I am an Analytical Scientist II.
What is the most rewarding part of your job?
It is very rewarding when I am presented with a difficult analytical method development and I find a way to deliver a solution to the client. Sometimes it takes some “thinking outside of the box” to arrive at a solution which satisfies the client’s needs for an analysis. The key for me is always asking the right questions:
- Is this testing needed, or are there adequate tests being done to satisfy the quality attributes of the process/compound?
- Are there any historical examples of how a similar problem was handled in the past?
- Which techniques could potentially be used?
- Did I think of what the test method could potentially affect downstream?
What are your team’s latest achievements?
My team was surprised by the observation of a new impurity while optimizing and scaling up a legacy process. In order to help ensure that this new impurity was identified and evaluated for downstream impact, we were challenged to identify the impurity. The usual means of unknown impurity identification involves the use of mass spectroscopy (MS), but since the HPLC method that the impurity was being detected on was not LC-MS “friendly,” the compound had to be isolated separately and analyzed on an HPLC method that would not cause harm to the MS detector. The team had a brainstorming session and developed a plan involving the use of thin layer chromatography (TLC) to isolate the compound in the TLC medium, filter the medium, and prepare a sample for HPLC-MS. The plan was carried out and the impurity was successfully analyzed on the HPLC-MS, which provided the molecular weight of the compound, and allowed the chemist to ascertain the identity of the impurity.
How do you see those accomplishments affecting the pharmaceutical and biotech industries?
When my team isolated and characterized the impurity, we set a precedent, where attention to detail and quality came first. We were presented with a challenge, but took the extra time and care to identify potential impact to Safety, Integrity, Strength, Purity and Quality (SISPQ), showing we are willing and able to ensure we are building quality into our processes, and that we are committed to continuous improvement. Having a diverse technical team sets us apart, demonstrating our ability to quickly solve a potential problem, holistically.