At CDMO Live Europe 2026, Dr. Olivier Aebischer, Deputy CEO at Interlabor Belp AG, demonstrated how a structured, dual-path analytical approach can identify manufacturing root causes in days, using two real contamination case studies from the lab’s operations.
Pharmaceutical manufacturers often treat troubleshooting as an unavoidable cost center — slow by nature and expensive by necessity. Dr. Aebischer’s talk challenged that assumption. With more than 2,980 implemented analytical methods, instruments dedicated solely to troubleshooting, and the ability to collect samples on-site, Interlabor Belp AG has built a model that compresses investigation timelines without sacrificing scientific rigor.
The foundation is what Aebischer calls a lean troubleshooting workflow: a five-step sequence moving from customer problem through information gathering, sampling, technical concept, and analysis to conclusion. The key is that each phase feeds the next with minimal delay, enabled by flat hierarchies and fast internal approvals. “It’s not the problem that follows the right path — we have to be flexible and adaptive. The key to speed is this ability to switch your path and do something different.”
Case Study 1: Benzene in a Finished Product
The first case involved benzene detected in a customer’s product. Rather than pursuing a single line of inquiry, Interlabor ran two hypotheses simultaneously. Hypothesis A: benzene was forming from sodium benzoate in the liquid matrix under certain conditions. Hypothesis B: benzene was present as a contamination in the propellant.
To test Hypothesis A, the team used selected ion monitoring to track benzene formation across different mixing times. Results were clear: at pH below 8, benzene concentration rose from 0.6 parts per million (ppm) at 30 seconds of mixing to 1.6 ppm at 4 minutes. When the pH was adjusted upward with sodium hydroxide, benzene concentration held steady at 0.4 ppm regardless of mixing time, pointing to oxygen contact at low pH as the formation mechanism. Hypothesis A was ruled out.
For Hypothesis B, Interlabor analyzed propellant samples stored at -80°C — a condition that preserves volatile contaminants. Gas chromatography–mass spectrometry (GC-MS) traces confirmed benzene in the propellant source. The root cause was identified: the product was benzene-free when the correct propellant was used.
“Structure creates clarity,” Aebischer noted. Running parallel hypotheses rather than sequential ones meant no time was lost confirming dead ends before pursuing alternatives.
Case Study 2: Unknown Residue in a Production Pipe
The second case arrived as a customer request: identify an unknown yellow, creamy substance found in a pipe. The investigation ran over 4 days and demonstrated what Aebischer describes as a “broad-to-specific” narrowing approach.
Day 1 established appearance and solubility — the residue dissolved in tert-butyl methyl ether (tBME). Day 2 brought scanning electron microscopy with energy-dispersive X-ray spectroscopy (SEM-EDX), which showed the residue formed flakes on the swab with a composition of 93% carbon and 7% oxygen. Standard infrared (IR) spectroscopy produced spectra too overlaid by the swab material to interpret; an IR microscope resolved this on the same day.
Day 3 brought identification. GC-MS comparison of the contaminated swab against a blank swab produced a strong spectral match with cholesterol. On Day 4, GC-MS screening of the processed materials identified the source. The root cause was a cholesterol-containing input material — and production restarted within the week.
Aebischer framed the analytical decision-making in this case as a balance between what he called “symphony and jazz”: following a structured protocol where the science is well understood, but improvising method selection when real conditions require adaptation. The use of the IR microscope — specialized equipment not in a standard toolkit — was a response to a method that failed under field conditions.
Takeaways
- Structure the investigation before starting analysis: parallel hypothesis testing prevents sequential dead ends and reduces total elapsed time.
- Maintain instruments and capacity dedicated to troubleshooting; shared equipment creates scheduling bottlenecks that slow resolution.
- Collect samples on-site where possible and store under appropriate conditions (e.g., -80°C for volatiles) to preserve evidence quality.
- Use a broad-to-specific analytical sequence: start with fast, low-cost screening methods before committing to expensive or time-consuming techniques.
- Adapt method selection to real conditions — when standard equipment fails, specialized instrumentation (such as an IR microscope) can recover the analysis.
- Troubleshooting restores production confidence, not just compliance; speed of resolution directly affects manufacturing continuity.
