How Takeda streamlines assay transfer and troubleshooting with the MVS

When one of Takeda’s quality control facilities wanted to improve assay success rates by reducing liquid handling variability, they turned to Artel. See how the MVS helps their assay process.

Dozens of assays

At any given time, Takeda’s quality control facility runs as many as a dozen different assays. Keeping them all performing within specifications can be time-consuming.

⇑Efficiency of assay troubleshooting

Using an MVS reduced the total amount of time spent troubleshooting atypical assay results.

⇑Accuracy and precision of liquid transfers

Using an MVS for pipette user competency assessment and calibration/volume verification of automated liquid handlers greatly increased the overall accuracy and precision of all liquid transfers.

Product used: MVS, Pipette Training Service
Applications: Quality, Assay transfer, Assay troubleshooting,
Pipette user competency evaluation

SITUATION

As part of their product release process, Takeda’s quality control facility in Lexington, MA, is constantly running dozens of different assays. These assays vary in complexity and can take anywhere from 30 minutes to one week to complete.

When an assay fails, the QC team launches an investigation to determine the cause. Once a cause is identified, they develop a fix and potentially improve productivity by preventing a recurrence of the error.

CHALLENGE

However, when the cause was related to the variability in pipetting performance between different scientists, they had a difficult time digging into the details.

“We have lots of documentation on
various parts of the assay, but we don’t have a videotape that would allow
us to go back and review the manual pipetting process,” observed Patrick Deitemeyer, Senior Development Specialist at Takeda.

SOLUTION

The QC team turned to the MVS for help, using the instrument to quickly determine if assay failure was due to variability in human pipetting or the automated liquid handlers being out of spec.

“The biggest benefit we have derived from the use of the Artel systems is time savings in our total assay process. In the event we get an atypical test result, we can immediately verify that the people and robots had been pipetting correctly, so we can move the investigation quickly in the right direction.”

Investigating atypical assay results takes time and diagnosing pipetting variability can be challenging

Takeda’s quality control (QC) facility in Lexington, MA, handles product release testing for the company’s enzyme replacement therapies. This means they can have as many as a dozen different assays running at any given time, each of which needs to be kept delivering high-quality data. So when a problem occurs and an assay generates atypical results, the QC team launches an investigation.

But assay investigations take time, leading to data delivery delays, loss of analyst time for repeat runs, and overall lower productivity. In addition, it turned out that when the source of the problem was pipetting variability, the QC team didn’t have enough insight into the exact problem to create a fix, “We have lots of documentation on various parts of the assay, but we don’t have a videotape that would allow us to go back and review the manual pipetting process,” observed Patrick Deitemeyer, Senior Development Specialist at Takeda.

The QC team turned to the MVS for help.

Patrick Deitemeyer
Senior Development Specialist at Takeda

The MVS can help across the complete assay process

The MVS was already being used elsewhere in the facility to calibrate automated liquid handlers and, working with Artel’s Applications team, the group at Takeda realized they could also use the MVS for assessing the pipetting performance of their analysts.

Now, the QC team uses the MVS to improve overall productivity across all aspects of their assay process:

Annual pipette user competency assessment. After their initial assessment of how well their analysis pipetted uncovered the importance of training, they now hold yearly pipette re-certifications and on-boarding new analysts includes pipette training (Figure 1). As a result, the accuracy and precision of all manual pipetting steps are more uniform from analyst-to-analyst and assay reproducibility is improved.

Figure 1. Representative pipetting skills assessment of 53 QC analysts dispensing 10-μL
aliquots of sample (n = 5) prior to receiving pipetting technique training (left) and after training (right).

Assay transfer. An additional benefit that arose from using the MVS to ensure the accuracy and precision of manual pipetting was that they could get more efficient assay transfers from the bench to automation. With the MVS, they could verify that the manual pipetting steps were occurring within the same specifications as the automated pipetting, leading to better reproducibility between manual and automated assays.

Assay troubleshooting. They also use the MVS to speed assay troubleshooting. Whenever they get an atypical assay result, they can quickly and easily rule out/rule in if liquid handling was a contributing factor before moving on to assessing other causes that take longer to explore.

Thus by using an MVS, the Takeda QC facility standardizes liquid handling throughout the facility, and can now extend that standardization from site-to-site. And by standardizing liquid handling, they improve overall productivity, speeding assay transfers and troubleshooting, and improving overall liquid handling accuracy and precision.

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