People are the chemistry: Andrew Blakinger
At Eurofins Lancaster Laboratories, we believe that our people provide our strength. Their dedication to quality, professional competence and hard work are the key elements in the company’s success. In this regular feature, we introduce you to some of the people who have helped make Eurofins Lancaster Laboratories an industry leader.
Fresh out of Clemson University, with a BA in chemistry, Andrew Blakinger began his career with ELLI in 2012 as a Chemist in Method Development & Validation. Earning three promotions in four years, Andrew is currently Manager of Extractables & Leachables Testing. “For our E&L clients, we use screening methods to test pharmaceutical packaging and manufacturing components to determine what compounds could leach into the drug product that may be toxic or reduce the efficacy of the drug,” says Andrew. “Over the past year we have been focusing our growth in the area of medical devices. While we have performed E&L and chemical characterization testing on devices for years, our new focus is allowing us to help our clients achieve regulatory approval faster while minimizing the need for animal testing,” Andrew adds. “As part of our new effort to serve medical device companies, we now offer testing in support of ISO 18562. This new standard, released in March 2017, is specifically geared at the evaluation of breathing gas pathways for a variety of unique hazards.” Another area Andrew’s group has been focused on is electronic nicotine delivery systems (ENDS). “With e-cigs and other ENDS now falling under FDA regulation, there is a plethora of testing required for these devices. My group has been taking the lead in establishing the necessary testing, which not only involves E&L but also includes analyses ranging from container closure integrity testing (CCIT) to raw materials testing.” Motivated by the interactions and daily collaborations with his clients, Andrew says, “I like keeping abreast of the common practices in the industry as well as working with clients to design studies that meet their specific goals and will hold up to the scrutiny of regulatory reviewers.” In recent years, Andrew has presented at a PharmaED conference and co-published articles in Pharmaceutical Technology and American Pharmaceutical Review.
What is the scope of your group?
My group of 30 scientists conducts extractables and leachables (E&L) evaluations of pharmaceutical packaging, bioprocess manufacturing components, and medical devices. These evaluations typically start by exposing the test sample, such as a bioprocess bag or a plastic bottle, to a variety of extraction solvents at elevated temperatures. Then, the resulting extraction solutions are tested by liquid chromatography mass spectrometry (LC/MS), gas chromatography mass spectrometry (GC/MS), and inductively coupled plasma (ICP) with detection by either optical emission spectroscopy or mass spectrometry. We then work hand-in-hand with toxicologists to help our clients understand the potential impact that any detected extractable compounds may have on patient safety. To support leachable stability studies, we frequently develop and validate methods for specific leachables of concern. Additionally, we perform unknown peak investigations by mass spectrometry, often by Orbitrap or quadrupole time-of-flight (QTOF) LC/MS, to help clients identify impurities in their drug product.
What process improvements does your group initiate to serve clients better?
My group is constantly evaluating opportunities for process improvement. Over the past year, four members of my team and I have been trained in LEAN principles, a global focus for Eurofins. Here is what we’ve been working on recently:
- In December 2016, the E&L group began exclusively using electronic laboratory notebooks (ELN) instead of paper notebooks to document lab activities. ELN greatly improves the efficiency of our analysts in the lab while also helping to ensure data integrity (e.g., by pulling sample weights directly from balances and maintaining full audit trails).
- E&L specific training modules complete with practical, hands-on exercises–one for each analytical technique utilized–were implemented in the fall of 2017. This training has reduced the time required to train new employees while also ensuring they have a sufficient level of experience prior to analyzing actual client samples.
- We implemented a group of data processing computers for our LC/MS and GC/MS systems in November 2017. As a result, multiple analysts are now able to process data simultaneously even while the instruments are being used to analyze samples.
- Currently we are in the process of validating a spreadsheet for ICP-OES data processing. This validated spreadsheet will minimize the opportunity for errors while also reducing the time needed for data review.
- We are working to institute a paperless workflow for our ICP-OES data to reduce the amount of printed data. Back in 2016, we implemented a similar paperless workflow for our LC/MS and GC/MS data that reduced the amount of paper printed by our group by dozens of reams of paper each month.
How would you characterize your leadership style?
I have a very collaborative and participative leadership style. I believe it is extremely important to listen to the ideas of my employees to get their input. When implementing a new process, it is important to hear everyone’s concerns and ensure there is buy-in from the entire group.
And when you’re not working?
I just started playing golf last summer for the first time in 15 years. Despite being pretty bad, I’ve been having a great time hitting the links with friends most weekends. I also spend a lot of my time working on various tasks around the house. I just purchased my first home a year ago, and it seems like my to-do list for projects in and around the house is neverending. Currently I’m working on building another raised bed for vegetables and selecting perennial flowers to plant around the yard.