- At J&J, the team developed data-driven models to create a reference space for product fingerprints.
- This enables repeatable, scalable ID testing without needing a specific reference sample each time.
- If a sample drifts outside of acceptable quality limits, it shouldn’t pass ID testing.nanoDSF can serve as an early warning system, flagging degraded or compromised samples before they move further along the pipeline.
- This makes nanoDSF not just a tool for identity verification, but also a quality safeguard.
- Even subtle structural or formulation differences can yield distinct thermal unfolding profiles.
- The technology accounts for concentration effects, buffer environments, and matrix composition, making it sensitive to a range of variables.
- The speed and accuracy of nanoDSF makes it ideal for either batch or continuous manufacturing.
- Results can be delivered within hours, allowing for fill-at-risk strategies—minimizing downtime while maintaining quality.
- Thermal stability of biologics is tracked during manufacturing to assess impacts of stress.
- Low-concentration products benefit from nanoDSF detection of intrinsic fluorescence, outperforming traditional absorbance techniques.
The technology is more than just compliant—it’s transformative. Interested in exploring Prometheus Panta C for your own lab? Visit our dedicated page.
As Dr. Müller put it, “Even we, in this regulated environment, can get so much out of it.”
From robust ID testing to nuanced formulation discrimination and continuous manufacturing integration, nanoDSF technology supported by Prometheus Panta C is enabling a new level of precision and efficiency in biotherapeutic development at Johnson & Johnson.
Key Learnings:
Notably, nanoDSF could even distinguish between different generations of the same product following formulation changes—something many conventional techniques like dot blot assays cannot do.
5. When it comes to formulation fingerprints do you need a reference standard? Or can nanoDSF stand alone?Another major advantage of nanoDSF is its ability to operate without constant reference to physical standards:
What is the impact of stress conditions on identification accuracy? Dr. Müller noted that while this can alter the thermal profile and potentially prevent correct identification, that’s precisely the point:
4. What happens under stress or suboptimal storage conditions?
This makes nanoDSF ideal for complex portfolios, including bispecifics and tri-specifics, where high discrimination is essential.
3. How precise is nanoDSF? Can it distinguish similar Biologics?When asked whether nanoDSF could differentiate between structurally similar products, such as closely related IgG1 antibodies, Dr. Müller confirmed that:
This makes both the nanoDSF technology and the Prometheus Panta C instruments valuable assets for modern manufacturing paradigms, including campaign-based or fully continuous models.
In the context of continuous manufacturing, a key concern is whether ID testing with nanoDSF keeps up with faster processes. Dr. Müller shared his experience:
2. Batch vs. continuous manufacturing: How does nanoDSF hold up?
nanoDSF, supported by the Prometheus Panta C stands out for its reliability in regulated environments, providing robust data without compromising standards.
Dr. Müller highlighted how his use of the technology has evolved over the last seven years, to become a “workhorse” for process characterization and stress testing. In particular:
1. Beyond ID-testing: Where else is nanoDSF making an impact?
Here are five questions asked by our audience and what they reveal about the technology’s capabilities:
The Q&A session revealed powerful, practical applications in a regulated pharma environment.
At a recent webinar hosted by NanoTemper, Dr. Marius Müller of Johnson & Johnson Innovative Medicine shared valuable behind-the-scenes insights into the use of nanoDSF™ technology (supported by the newly launched Prometheus™ Panta C instrument). His team not only benefits from nanoDSF for precise identity (ID) testing of biologics but across multiple stages of biotherapeutic development.