Event Details

Dec 12 – Dec 12, 2017

Asia: Method Development and Qualification Considerations for Octet-Based Potency Assays

  • Webinars

The pressure to improve speed to market directly impacts the analytical assay development timeline. The current industry standard from target to phase I clinical trials is 18 months, with companies such as KBI Biopharma targeting 8 months.  Potency assays are often time consuming to develop and require significant investment to demonstrate reproducibility. With the advent of BiAb therapy, dual binding potency assays have also become critical to successful filing. Developing a dual binding assay that demonstrates binding to two separate antigens is not only technically challenging, it requires even more time to develop. KBI Biopharma has rapidly developed a variety of Octet® based potency assays and successfully qualified the methods. Throughout development and qualification, there are many important factors to consider such as method type, loading factors, accuracy, precision, specificity, range, linearity, and parallelism. The Octet® platform has the ability to assess each of these parameters rapidly, supporting accelerated timelines.