Cell Line Development

The clinical and commercial success of biotherapeutics hinges on developing robust, reproducible, and scalable processes. KBI's extensive process development and analytical development capabilities help our partners generate active products at an attractive cost while enabling rapid, reliable transfer to c...

With top expertise in protein analytics, KBI has successfully completed over 3300 analytical projects for more than 300 customers and more than 130 distinct molecules.


Our experience includes antibodies (IgG1, IgG4, IgM, FAb, ADC, Fc fusion), enzymes, cytokines, growth factors, highly glycosylat...

KBI’s approach to formulation development is based on the strategic pairing of two complementary scientific disciplines:
• Establishing a comprehensive understanding of the thermal, physical, chemical, and conformational stability. • Employing statistical design-of-experiment (DOE) to evaluate main ef...

Scale-down process characterization studies performed using a qualified scale-down model are a critical part of licensure applications for biologics. 

KBI has significant expertise in the design and execution of these studies to enable customers to define their process control strategy to take ...

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™.