Now Streaming On-Demand The bioscience industry operates within a highly regulated environment, where adherence to compliance standards is critical for patient safety, product efficacy, and market approval. Regulatory bodies such as the FDA, EMA, and WHO enforce stringent guidelines covering drug development, clinical trials, manufacturing, and post-market surveillance. However, ensuring regulatory compliance has traditionally been …
Now Streaming On-Demand The bioscience industry operates within a highly regulated environment, where adherence to compliance standards is critical for patient safety, product efficacy, and market approval. Regulatory bodies such as the FDA, EMA, and WHO enforce stringent guidelines covering drug development, clinical trials, manufacturing, and post-market surveillance. However, ensuring regulatory compliance has traditionally been …
AI-Driven Compliance: Harnessing Machine Learning for Regulatory Excellence Read More »
Now Streaming On-Demand Dr. Kamala’s presentation, “Mitigating Target Interference Challenges in Bridging Immunogenicity Assay to Detect Anti-Tocilizumab Antibodies,” provided valuable insights into overcoming challenges in immunogenicity testing. Key takeaways include: Addressing Target Interference: The presentation highlighted the development of a robust immunogenicity assay to accurately detect anti-tocilizumab antibodies, even in the presence of high levels of …
Now Streaming On-Demand While significant advances have been made in terms of ultra-sensitive technology platforms for measurement of biologics and biomarkers, most platforms requires high capital investment and significant re-work of existing immunoassays. We present case studies where we are able to adapt the current ELISA methods to achieve 5-50x more sensitivity. The adaptation involves …
Now Streaming On-Demand Challenges and Solutions Development and Validation of Omalizumab Clinical Assays Watch Now! Complete the form to view the recording.
Now Streaming On-Demand The webinar began with an introduction to abatacept, its mechanism of action, and its clinical indications. The speaker then discussed the challenges faced in the development of abatacept biosimilars, including analytical and clinical challenges. The speaker also provided an overview of the regulatory landscape for abatacept biosimilars and discussed the key requirements …
