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On the 20th and 21st of October 2022, Excelsus Structural Solutions (ESS) celebrated its 10-year anniversary with a very successful two-day event at Park Innovaare. The event started with a special “Meet an Excelsus expert” workshop session and a visit of the large-scale research facilities at the Paul Scherrer Institute. Further workshops followed on pharmaceutical applications of synchrotron X-Ray Powder Diffraction and complementary techniques. Finally, a big Party preceded by emotional celebration talks nicely closed the event on Friday evening.
Fabia Gozzo, CEO and founder: “The event has brought together loyal customers, as well as experts from the pharma industry and international researchers for the presentation of new applications and methodologies and vivid discussions about what needs to be further developed and improved.”
Anniversaries – time to look back and head
Excelsus Structural Solutions (ESS) was founded in March 2012 as a spin-off of the Paul Scherrer Institute (PSI) with the intent of facilitating industry access to Synchrotron X-Ray Powder Diffraction (S-XRPD) tools tailored for the structural analysis, trace and quantitative phase analysis of pharmaceuticals. Since then, ESS has offered synchrotron-radiation based analytical services to the industry adhering to principles of rigour and innovation. In 2016, ESS joined the Switzerland Innovation Network becoming a resident of the PARK INNOVAARE located in Villigen near the Paul Scherrer Institute. Along the years, ESS has seen extraordinary advances in analytical service capabilities alongside the needs of the industrial customers it serves. This evolution is set to continue: the 10-year anniversary was an opportunity to reflect back on ESS’ notable milestones, but it is also a chance to refocus for the future.
Success story of ESS
Over the last decade, ESS has exploited the enormous potential of the S-XRPD technique and its own deep experimental and computational competencies to solve challenging problems and accomplish notable milestones in the pharma & chemical industry. One such example, which is at the heart of the pharma industry, relates to the ability to identify and quantify crystalline solid polymorphs in both drug substances and formulations. Many active pharmaceutical ingredients (APIs) are solid in nature and could exist in different crystalline forms that vary significantly in their physicochemical properties, leading to different biopharmaceutical behaviors. As early as 2013, when the founder Fabia Gozzo was still the only member of the company, ESS succeeded in detecting and quantifying traces of API in pharmaceutical mixtures smaller than 0.05 wt % using S-XRPD. Later on, by optimizing the beamline optics, it became possible to push the lowest limit of detection to an unprecedented level hitting 0.01 wt % .
Synergies of methods and tools
Methods and instrumentation are bound to evolve together and when it is possible to achieve synergy between them it becomes feasible to solve outstanding challenges. Along this perspective, another ESS milestone concerns the extension of the experimental protocol used for the detection of traces of crystalline forms in pharmaceutical compounds to protein powders. A vertical focusing of the beam combined with data collection at multiple detector positions enabled ESS to achieve the highest d-spacing resolution structural model ever achieved for the studied peptide octreotide using X-Ray powder diffraction methodologies.
Patent protection for solid forms as intellectual property
New solid forms are also relevant for intellectual property considerations, as solids with superior properties can be patent protected. S-XRPD, thanks to its capabilities of directly detecting and unequivocally identifying solid forms at trace levels, plays a key role in the field of intellectual property of pharmaceuticals. Since its foundation, ESS offers a consultancy service to law firms in the context of patent litigations and patent filing.
Key to these ten years of successful operations has also been the development of a substantial network of collaborators within the S-XRPD community and of industrial and academic user community. This has been facilitated by ESS co-organizing workshops in this area, i.e. the Spring Pharmaceutical Synchrotron X-Ray Powder Diffraction Workshop held at Purdue University (US) in 2018 and the 16th Pharmaceutical Powder X-Ray Diffraction Symposium and the 2nd Spring Pharmaceutical Synchrotron X-Ray Powder Diffraction Workshop held at the PSI in Villigen in 2019.
The 10 years celebration event
The anniversary event has been a great platform for vivid discussions, bringing together experts from the pharma industry, S-XRPD community, academic scientists, and representatives of law firms to exchange on current challenges in Pharma Research & Development, latest opportunities offered by S-XRPD and emerging complementary techniques, such as electron diffraction in collaboration with the Belgian company Nanomegas and the Swiss company Eldico Scientific and Small-angle X-Ray Scattering with the group led by Cinzia Giannini at the Institute of Crystallography at the Centro Nazionale Ricerche in Bari, Italy. The first half-day workshop focused on polymorphism and methods while the second day was devoted to the presentation of significant industrial case studies from ESS’ customers using S-XRPD and to complementary techniques. Some of the presentations were live-streamed to enable people that could not be present in person. Overall, there were many interesting discussions, often stimulating ideas for future collaboration. Very fascinating has been the perspective given by the experienced US Covington & Burling’s attorneys on the use of S-XRPD for patent litigation, which caught the attention of many scientists, because of this unusual topic during a scientific workshop.
Before the closing celebration party, Fabia Gozzo, CEO and Founder of Excelsus Structural Solutions shared with the invitees her retrospective thoughts on this exciting and often difficult adventure. She identified the past 10-year milestones and took the opportunity to acknowledge the support from PSI, Park Innovaare, colleagues, and collaborators. Benno Rechsteiner, CEO of Park Innovaare, and John Millard, head of the Paul Scherrer Institute Technology Transfer, discussed the efforts of their institutions to promote the technology transfer and kindly shared their memories of the past 10-year successes of Excelsus. The speeches ended with the contribution of Christian Broennimann founder and Chairman of the Board of the successful PSI spin-off Dectris who shared many memories of the early days of the Swiss Light Source with Fabia Gozzo. Christian Broennimann acknowledged her contribution to the success of the detectors that his company commercialized and spent encouraging words for Excelsus and its future.
“This has been definitively the time to celebrate 10 years of success. But this is also the moment to look forward to the next ten years. Considering the last decade, the future looks bright: challenging problems have been and are being tackled successfully, and new capabilities are under development”, said Fabia Gozzo.