Integrated services for first in human, matched to your molecule
Engineering New Biologics, At Scale
Making Complex Applications Possible with Mammalian-Based Expression for New Biologics
With a solid foundation in analytics combined with our best-in-class cell line development (CLD) platform, KBI provides vertically integrated services for First in Human (FIH) programs from CLD through to commercial manufacturing.
The increasing complexity of novel therapeutic proteins adds pressure to established modes of expression, including Chinese Hamster Ovary (CHO) cell lines. At KBI Biopharma, as a global partner for mammalian-based biopharmaceutical development, we have engineered this standard workhorse to create our premium proprietary cell line for mammalian-based expression.
Mammalian cells are the gold standard for biologics as a key expression system for the production of new biologics - including therapeutic proteins like monoclonal antibodies (mAbs). CHO cells, specifically, are used for around 70% of recombinant biopharmaceutical proteins. KBI's premium cell line development services, combined with our deep expertise in analytical development, process development, and formulation development, create a comprehensive workflow that can solidify mammalian expression for a variety of molecule types from CLD to infinity.
A Match for Breakthrough Molecule Types
KBI is redefining how mammalian-based expression is used in route to the development of new biologics, which ultimately strengthens the role of CHO cells in biopharmaceutical protein generation.
- More than 20 years of world-class innovation, pioneering cell line development
- KBI's SUREtechnology Platform™, powered by Selexis®, including our proprietary KBI SURE CHO-M Cell Line™
- Expertise in high-value bispecific and multispecific antibody production
- Robust and versatile platforms and collaborative workflows for difficult-to-express proteins and bispecific antibodies
- Cost-effective, simplified workflow for mAb development
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More Power to Develop, Manufacture, Repeat
Innovative New Biologics Come to Life with Efficient Workflows
Protein and Process Expertise, Matched to Your Molecule
Our depth of experience and expertise in mammalian-based expression - from cell line development to commercial manufacturing - streamlines the creation of new biologics and breaks through common bottlenecks and barriers.
KBI Biopharma is a global partner for expert mammalian-based biopharmaceutical development. Our team of experts and world-class facilities around the globe ensure your success in developing new biologics. From cell line development to comprehensive analytical, process, and formulation development through to clinical and commercial manufacturing, working with KBI Biopharma delivers a streamlined experience.
When it comes to breakthrough molecule types, you have met your match.
KBI offers full support for full-scope mammalian programs with the depth of knowledge that makes the complex possible. Our team of experts delivers top-tier formulation experience with backing analytics. Future-proof your program with sustained excellence for every molecule at every stage of development.
Integrated Mammalian-Based Workflow for Phase I Programs
Mammalian Cell Line Development
The SURE CHO-M Cell Line is a proprietary, high-performance mammalian cell line derived from CHO-K1 cells and used to produce therapeutic recombinant proteins, including monoclonal antibodies.
- Fully-sequenced genome and transcriptome
- Fast doubling time with consistent high-level expression
- Fast, efficient scale-up to GMP production
The SURE CHO-M Cell Line was specifically developed to overcome common bottlenecks in protein expression, which can be time-consuming, labor-intensive, and dependent on the gene of interest to be expressed.
Mammalian Monoclonality Assessment
Characterizing transgene-genome junctions is mandatory for IND filing and for assessing the monoclonality of both research cell banks (RCBs) and master cell banks (MCBs). This genomic data is critical to the success and cost-effectiveness of biomanufacturing and clinical trials.
- Rapid, robust genomic characterization
- Proprietary technologies, platforms, and processes
- Ready-to-use data packages to support decision-making and regulatory filings
Using a combination of whole genome sequencing by next-generation sequencing with Illumina technology, and proprietary bioinformatics tools, we are able to develop a comprehensive data package that is ready-to-use for IND filing. We also offer unique, customizable monoclonality assessment services like Fluorescence In Situ Hybridization (FISH) with a proprietary high-throughput Karyotyping technology.
Mammalian Process Development
The clinical and commercial success of new biologics hinges on developing robust, reproducible, and scalable processes. Our process development activities cover the full development cycle:
- Early-stage discovery efforts
- Small-scale protein production
- Fully-integrated, comprehensive process development leading to GMP manufacturing
- Process characterization
- Scaled-down validation studies
Our deep knowledge and experience in the science and practice of biopharmaceutical drug development make us an ideal partner for process development.
Mammalian Analytical Services
KBI employs a phase-specific lifecycle approach to analytics. Our experience includes antibodies like IgG1, IgG4, IgM, FAb, ADC, and Fc fusion, enzymes, cytokines, growth factors, highly glycosylated proteins, protein vaccines, PEGylated proteins, conjugates, peptides, adeno-associated viruses (AAVs), oligonucleotides, and other unique proteins.
- 3000+ analytical projects
- 100+ clients
- 130+ distinct molecules
Our expertise includes HPLC, CE, ELISA, UV-Vis, mass spectrometry, light scattering, biophysical characterization (DSC, CD, FTIR, fluorescence), binding assays (ELISA, Biacore, ForteBio), glycan analyses, cell-based assays, and others.
Our approach to formulation development is based on the strategic pairing of two complementary scientific disciplines: First, establishing a comprehensive understanding of the protein's thermal, physical, chemical and conformational stability, and second, employing statistical design-of-experiment (DOE) to evaluate main effects and interactions effects on protein stability. Together, these techniques enable KBI to develop robust formulations by eliminating uncontrolled stability variables, thus focusing solely on therapeutic performance and clinical outcomes.
- 130+ successful protein, peptide, and vaccine formulation development programs
- Creation of robust formulations by eliminating uncontrolled stability variables
- Stable liquid formulations for protein concentrations ranging from >1mg/mL to 200mg/mL.
KBI's data-driven approach can also strengthen responses to regulatory inquiries.
Clinical Mammalian Manufacturing
After becoming the first CMO in the world to implement the 2,000 L scale Xcellerex™ single-use bioreactor, KBI immediately began delivering GMP Drug Substance supplying first in human (FIH) and clinical resupply programs.
Our success is the result of our greatest asset - our team members. We are a diverse collection of experienced industry professionals who understand the impact these new proteins, antibodies, and vaccines have on human health. We put our hearts and experience to work, delivering outstanding quality.
Commercial Mammalian Manufacturing
Building on KBI's legacy, our commercial manufacturing suite is equipped with flexibility, taking advantage of single-use technologies for each unit operation and leveraging our extensive experience with large-scale single-use equipment.
Experience The Power Of End-To-End Bispecific Antibody Production
Delivering On The Promise Of Bispecifics: State-Of-The-Art Bispecific Antibody Development
Given the complexity of bsAbs, a cell-line development platform for these proteins must contain three key features to be sufficiently robust for generating bsAbs: stable and high expression of bsAbs, straightforward early screening, and a robust cell line that can handle stressors. Furthermore, advancing bsAbs from the bench into the clinic requires process development, analytical methods, and scale-up for cGMP manufacturing. We have created a leverageable, integrated workflow that generates high-quality clinical bulk drug substances under accelerated timelines.
Streamlined Development For Efficient Production Of Bispecific Molecules Using An Integrated Platform Process
This webinar demonstrates a breakthrough platform approach that encompasses the efficient production of bispecific molecules in an integrated, streamlined way, from CLD (cell line development) to cGMP manufacturing. The leverageable integrated workflow from Selexis and KBI Biopharma generates high-quality clinical bulk drug substances under accelerated timelines.
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