Approaching Instrument Changes in QC: One Team's Journey on Changing from the iCE3 System to Maurice C.

Tell us about Boehringer Ingelheim and how its products/services impact human health.

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. 

What is your team’s specific area of focus/expertise and your role within the team?

The Analytical Sciences and Technologies Unit here at Biopharmaceuticals QC in Biberach focuses on the late lifecycle management of analytical methods. This involves method transfers, re- and co-validations, as well as method, technology and digital innovation. In this team, I put special emphasis on lifecycle strategies, aiming at a scientific basis to increase release efficiency and robustness. 

What were the main factors driving your decision to replace your iCE3 platforms with the Maurice C. system when you did?

The main driver was the need to secure long-term continuity of release analytics as the established iCE3 platform approaches support discontinuation. Plus, we saw opportunities, such increased data integrity through complete Empower access as well as the use of native fluorescence for analyte detection on Maurice C.

One important aspect was also saving double maintenance costs for both iCE3 and Maurice C as early as possible, which is why wanted to be proactive.

In addition, this approach gave us enough room to set up a universal study design for instrument changes in general. The iCE3 to Maurice C transition then became the benchmark of our study design. The core of our study design is a focus on the instrument readout, instead of comparing individual instrument specifications or re-validating all our methods. We generated comprehensive performance data that would in the end support a science-based decision on whether seamless release continuation, partial method re-validation, or full method re-validation are appropriate.

What were the timelines for designing and completing your bridging studies?

We started our study setup in May 2022, when we still had plenty of time for the transition to be completed. As you can imagine, this is one of the projects that do not have highest priority compared to release or validation studies. Plus, we aimed at setting up a study design that would be universally applicable to further instrument changes in the future. Therefore, it took us 2 years in total to transition the affected products from iCE3 to Maurice C. However, using our study design and with a stronger focus on the transition project, I am sure that this can be done in a much shorter timeframe now. 

If your readers have similar projects in planning: We published the study design later on in the Journal of ELECTROPHORESIS and it is publicly available and providing the comparability data of iCE3 and Maurice C.

Please describe the results of your study and your conclusion.

In the study, Maurice C showed equal or better performance compared with the iCE3 platform. 

More broadly, the results demonstrated that a structured, universal comparability concept can support efficient and science-based instrument changes in regulated pharmaceutical QC.

Were there aspects of the bridging study that you found easier than anticipated? 

One aspect that was certainly of high value and an accelerator to the study was the available historical QC and validation data. While we often complain that working in a QC environment comes along with very strict guidelines and limitations – working in QC also has a really big advantage: We have lots of high-quality long-term data.

Once the right performance parameters and acceptance logic were defined, the existing data became a powerful reference point that ultimately made additional measurements on iCE3 obsolete. Instead, the historical data provided a statistical power that would otherwise be impossible to generate in a focused study design. We used the existing data to set acceptance criteria and run measurements exclusively on Maurice C. 

Is there any specific advice or resources you would recommend to other iCE3 Users who are transitioning to Maurice?

My main advice is to aim at a science-based approach rather than directly considering extensive re-validation activities. If you look for inspiration on how to do this, feel free to have a look at our publication. There is little literature available on lifecycle challenges, which is why we wanted to publish the strategy. Even though this is certainly not the only way to transition from one instrument to another, we believe that it proved efficient and can be helpful to others. And we consider it highly valuable to engage with the community and learn from each other on how to approach such situations. Therefore, I would also like to thank BioTechne for giving me the opportunity to share our experiences here – I believe this is a great chance to engage with the field and build connections.

As another resource, I recommend a BioQC Expert forum on the topic (Best Practices: Updating Analytical Procedures | BioQC) and generally the BioQC online platform, where this and other topics are made available to all of us: BioQC | Expert Insights on Biopharmaceutical Quality Control

Let’s talk about our challenges and solutions, no matter what company or country we are from: When it comes to life cycle management, we are all in the same boat.

What were the major improvements you experienced between the iCE3 and Maurice C. platforms?

Major improvements I see between iCE3 and Maurice are facilitated cartridge handling, the improved data integrity in Empower environments, and the option to use native fluorescence detection. This is indeed a very attractive technical opportunity as it gives you less noisy baselines and therefore easier integration procedures, even though in our instrument change, we didn’t switch from UV to fluorescence detection as detection mode and sensitivities would not be comparable. But in the long run, it is truly attractive to have the option to switch.

In terms of instrument performance, Maurice C performs in our hands equally well or better than iCE3. One disadvantage I would see in the cartridge design of Maurice is the increased amount of waste generated through the limited number of possible injections per cartridge. As far as I know, BioTechne is working on this and already offering cartridges with increased injection numbers.

Have you or any of your colleagues brought in any other Maurice platforms into your lab, and what additional benefits do they provide?

In our Quality Control department we are exclusively using Maurice C – and this is also what we addressed in our benchmark study. However, I hear from our colleagues in development that the Turbo CE-SDS options of Maurice and the fractionation of MauriceFlex are well appreciated in screening and characterization contexts.