Spectradyne once again participated in the annual PepTalk: The Protein Science Week. This conference is held each year in San Diego, and brings together experts from global pharma, biotech, academic, and government institutions. It features several interrelated technical tracks, including "formulation & stability" and "analytics & impurities", which were of particular interest to Spectradyne customers.
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Even though protein aggregation has been a hot topic for several years, it is surprising that many researchers still have a "measurement gap" in their laboratories, between very small aggregates (monomer to 50 nm) characterized by chromatographic methods, and very large aggregates (larger than 2 μm) characterized by flow imaging or light obscuration. This is the exact size range that the Spectradyne nCS1TM fills perfectly, so we continue to be well-received by people who realize that measurements in this size range are important to get right. At our booth and with our poster, "Submicron Protein Aggregation Measurements for Early Assessment of Formulation Instability", we continued to stress that detecting aggregation earlier can save formulation scientists considerable time and money early in the formulation process. This message continues to be well-received, especially as the FDA is now emphasizing the importance of these characterizations in both the IND (Investigational New Drug) and NDA (New Drug Application) application processes. The fact that the nCS1TM only requires 3 μL of sample is also critical, as in many cases of the early formulation process, sample volumes can be as small as 20 μL total.
What seemed new at this year's event was that there was quite a bit of discussion on the topic of alternative delivery methods for biologics. In particular, many people were talking about using viral vectors (AAV, lentivirus, etc.) and engineered extracellular vesicles (EVs) as delivery mechanisms for biologics. There is much interest in more effective treatment of diseases of the central nervous system (CNS), which require a mechanism to cross the blood-brain barrier, which viral vectors and EVs are capable of. The nCS1TM is also well-suited to characterizing viral vectors and extracellular vesicles, so can help researchers in this area as well. Of particular importance is correctly characterizing sample concentration, as this corresponds to dosage. The nCS1's electrical detection method provides superior concentration measurements versus other (especially optical) methods, in minutes as opposed to hours for classical assay-based titers.
We saw many existing customers, and spoke to many new prospects as well at this event. Participation in events like this are an excellent opportunity for us to learn what the current and future needs of this market are, so that we may better tailor our technology to aid in the advancement of this important science.
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