04.16.20 -- Biosimilar Pipeline Sees 12 Percent Annual Growth

Process development of biologics is becoming more and more data and simulation driven. An example of this trend is the increased interest in mechanistic modeling. This approach allows you to simulate and predict chromatographic behavior and experiments in silico. This article outlines both the current opportunities and challenges for using mechanistic modeling for process development of chromatography steps.

Most chronic myelogenous leukemia (CML) cases are caused by a translocation between chromosomes 9 and 22 that creates an abnormal fusion gene, BCR-ABL1. This poster explains how Bio-Rad’s QXDx™ BCR-ABL %IS Kit quantifies the amount of BCR-ABL1 transcript as a ratio of BCR-ABL1/ABL1, then returns the value of molecular response (MR) on the WHO international scale(IS). The QXDx software performs automatic data analysis and reporting. Results are reported in %IS, MR, and copies values.

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