Stegmann Systems at CASSS Bioassays 2026

Two days of bioassay insights

From April 28 to 29, 2026, the annual CASSS Bioassays: Scientific Approaches & Regulatory Strategies symposium brought the bioassay community together at the Marriott Washingtonian Center in Gaithersburg, Maryland.
Our scientific team, consisting of CEO Dr. Ralf Stegmann and myself, took this opportunity to discuss current perspectives, strategies, technologies, scientific approaches, and regulatory considerations in bioassays.
5 May, 2026 / Dr. Andre Rölke-Wellmann
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Conference recap

Highlights from the scientific program

The scientific program was packed with inspirational and highly relevant talks, leading with a keynote presentation to the last 50 years of bioassays and current challenges in assay development, validation, and qualification. We also learned a lot about strategies and challenges for potency assays, specifically on multi-specific antibodies and antibody drug conjugates. The final sessions targeted alternative approaches and data science in bioassays.
In-between roundtable discussions allowed us to exchange ideas, experiences, and potential risks to various topics, like method comparability, applications of AI, or practical considerations on most recent ICH Q14, ICH Q2, and USP <1220> updates.
Booth demo highlight

From plate reading to data analysis in PLA 3.0

One visitor magnet at our booth definitely was the Spark® multimode microplate reader provided by Tecan. It allowed us to showcase streamlined and traceable data acqusition into PLA 3.0 with minimal user input. To show its versatility, we prepared three different assay plate examples: a parallel-line potency assay, a 4-parameter logistic potency assay, and an endotoxin detection assay. These examples gave attendees a hands-on look at how modern assay workflows can move efficiently from instrument output to structured data analysis in a single connected process!
Note: Visit Shorts for a first glimpse into data import from various formats.
Coming soon

Introducing the upcoming Method Validation Package for PLA 3.0

We also showed our new Method Validation Package for PLA 3.0, which is currently in the final phase of development. In alignment with ICH Q2(R2), ICH Q14, and USP <1033>, it allows you to define the analytical target profile and set up performance characteristics (e.g., accuracy, precision, linearity, total analytical error) according to your requirements.
With this addition, PLA 3.0 expands its capabilities beyond assay analysis, once more, to support the full analytical procedure lifecycle. Get ready to develop and validate your methods, calculate the reportable value, and trend critical parameters in your assay - all within one GMP-compliant software solution!
Community

Personal notes

It was my first time at CASSS, and I could not have been welcomed any better. From the very first moment, I felt integrated into the community. I met familiar and new faces alike, and it was great to see some of them in person for the first time ever. I was also excited to get to know representatives from different companies we have been working with in recent years. I will definitely look forward to meeting you all again.
Conclusion

Final words

CASSS Bioassays 2026 showed how important it is to bring scientific, regulatory, and technological perspectives together. I would like to thank the CASSS team for organizing the event. Big thanks also to all attendees that visited our booth with fresh ideas, invaluable feedback, and welcoming thoughts.
See you next time!