May 15, 2025
San Diego, CA, USA. With over 1,900 industry experts expected to attend, TIDES USA in San Diego, USA, offers a premier platform for scientific exchange, strategic collaboration, and showcasing transformative research from early development through to commercial launch. BioSpring will actively contribute to the scientific program with one workshop and expert presentations, highlighting its commitment to innovation and excellence in oligonucleotide manufacturing.
BioSpring’s Highlights
Dr. Jan Nickolaus, Head of Quality Control: “My workshop talk will explore the use of analytical methods such as NGS and LC-MS/MS to assess the purity, impurity profile, and biological activity of guide RNA. We will compare next-generation sequencing (NGS) and liquid chromatography–tandem mass spectrometry (LC-MS/MS), highlighting their respective strengths and limitations. Additionally, we will demonstrate how these techniques can be integrated into potential control strategies, supported by complementary assays—such as activity-based tests—to generate a more comprehensive understanding of guide RNA quality. By combining multiple analytical approaches, it becomes possible to gain deeper insights into critical quality attributes and their potential impact on therapeutic performance. This holistic view is essential for developing safe and effective RNA-based therapies.”
Dr. Sven Warhaut, Vice Head Manufacturing, is delivering a presentation titled: “A Novel Ultrafiltration/Diafiltration Method to Achieve High Concentrations of Nucleic Acids”. Ultrafiltration is widely used in nucleic acid manufacturing, particularly for the desalting and concentration of active pharmaceutical ingredients (APIs). With traditional ultrafiltration, the concentration that can be achieved is limited. This creates a significant bottleneck in the production of powdered APIs, where ultrafiltration is frequently used as a pre-lyophilization step and determines the maximum batch size that can be obtained with the freeze dryer capacity. Moreover, traditional ultrafiltration often cannot support the manufacturing of oligonucleotide solution APIs because it fails to exceed the concentration of subcutaneous drug products. To address these issues, BioSpring has developed an in-house ultrafiltration/diafiltration (UF/DF) technique, optimizing nucleic acid concentration and enhancing production efficiency.
Dr. Susann Rasmus, Head of Quality Assurance, and Dr. Ruven Jilly, Senior Head of Quality Control Lab, are giving a presentation entitled “Regulatory Feedback on Late-Stage Program – A CMO Perspective”. Advancing an oligonucleotide therapeutic into late-stage development presents unique challenges, requiring a well-defined regulatory and validation strategy. This talk provides key insights from a CMO perspective on molecule classification, process validation steps, regulatory expectations, and the role of release specifications. Additionally, it highlights best practices for analytical method validation tailored to Phase III and commercial programs, ensuring regulatory compliance and product success.”
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