Analytical Development

Built on the SUREtechnology Platform, SUREmAb optimizes monoclonal antibody (mAb) development and manufacturing processes, fast-tracking the path to clinic and market. • Fast-tracked for efficiency and speed, taking you from DNA transfection to GMP drug substance in 11 months • Comprehensive mAb develop...

With our advanced gene technology and proprietary cell line, we are able to overcome common bottlenecks that come with developing high-performance mammalian cell lines, especially when expressing novel molecule types.

Mammalian cells are the gold standard for biologics development. 

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To date, KBI has conducted over 130 successful protein, peptide, and vaccine formulation development programs. 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, chemic...

KBI Biopharma has extensive experience developing purification processes for a wide variety of biotherapeutics, including: -Monoclonal antibodies-Bispecific antibodies -Enzymes -Fc fusion proteins -PEGylated proteins -Complex glycoproteins KBI supports 40+ annual programs ranging from FIH (First-in-Huma...

KBI offers a full suite of CLD across both mammalian and microbial expression systems. KBI can apply established mammalian recombinant protein expression systems to provide rapid and industry-leading cell line generation services using: CHO-M Selexis SUREtechnology, CHO-ZN, CHO-DG44, CHO-S, and CHO-K1 GS. ...

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...

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 ...

KBI Biopharma offers a broad range of cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Our capabilities include reliable manufacturing for preclinical and clinical supply.

KBI’s experienced team produces high-quality therapeutics and vaccines thro...

KBI offers global cGMP Mammalian Production, and organizational highlights include:  • First CDMO to implement 2,000L single-use cGMP operations • High throughput single-use technology (AKTA Ready XL, 2500L SUM, 12m2 TFF) • A broad range of cGMP biologics manufacturing services from pre-clinical thr...

The KBI Boulder facility has extensive experience in generating E. coli based expression systems for high-level expression of recombinant proteins, typically using T7 expression in the BL21(DE3) strain as a platform. Following demonstration of expression in shake flasks, fermentation development ...

Mass spectrometry is among the most powerful analytical techniques available for protein characterization. KBI’s state-of-the-art mass spectrometry core facility delivers unparalleled structural characterization services to our clients. 
Our expert team brings decades of experience in protein and p...

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.