Titration Curve Modeling in Bioassay Potency Method Development

This year at CPHI Barcelona (24–26 October, 2023) we sat down with C-suite executives and HR professionals to discuss the looming talent crisis in the pharmaceutical industry. With hybrid working persisting post-pandemic and a growing skills gap, how can the pharmaceutical supply chain adjust to a changing labour force? 

An ideal therapeutic protein “factory” creates a pure target product with high titers from the start, which can minimize development risk, timelines, and cost. E. coli has long been implemented as a therapeutic protein factory due to its simplicity, tractability, and wealth of information characterizing the microbe.

While common E. coli expression strains alter as many as five genes to improve one aspect of recombinant protein expression, KBI has created a platform E. coli with about 1,000 genes altered and roughly 1 Mbp of DNA removed. The result is a PURE, efficient platform expression strain—PUREcoli™.

KBI Biopharma’s cell line development services, powered by Selexis®, have been at the forefront of innovation for the last two decades. We are introducing the latest version of proprietary SURE CHO-M technology, which uses a transposase-based semi-targeted integration method and provides high productivity and stable cell lines for therapeutic protein production, while exhibiting a doubling time of 15-17 hours. Using this transposase-based cell line, KBI Biopharma is now delivering tox material in as little as 6 months from transfection. The tox material will be generated with the top 6 clones. In addition, we are introducing an afucosylated host cell line for the generation of therapeutic proteins without any fucose residues. KBI Biopharma is also introducing a completely new targeted integration technology developed by our own next-generation sequencing software. This panel of new cell line offerings surpasses customer expectations and is set to establish new industry standards.