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Mammalian

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 mammalian CDMO 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 and manufacturing, 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 mammalian CDMO services combine our premium cell line development services with deep expertise in analytical development, process development, and formulation development to create a comprehensive mammalian-based biopharmaceutical development and manufacturing workflow that can solidify mammalian expression for a broad variety of molecule types from CLD to infinity. 

 

A Match for Breakthrough Molecule Types 

KBI is redefining how mammalian-based expression is used throughout the development and manufacturing of new biologics, which ultimately strengthens the role of CHO cells in biopharmaceutical protein generation. 

Explore More Mammalian:

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 biopharmaceutical development and 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 and manufacturing. 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 a variety of mammalian CDMO services, enabling us to provide 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 your mammalian-based biopharmaceutical development and manufacturing journey. 

 

Integrated Mammalian-Based Workflow for Phase I Programs

MammalianProcess

Mammalian Cell Line Development

As part of our mammalian CDMO solutions, our mammalian cell line development services leverage the SUREtechnology Platform, powered by Selexis, to provide you with best-in-class robust research cell banks (RCBs) generated from our proprietary SURE CHO-M Cell Line (CHO-M). These mammalian cell line development services include:

  • Genetic engineering: transgene codon optimization and signal peptide matching with integration in proprietary vectors containing proprietary epigenetic elements optimized for the CHO-M.
  • Optimized transfection protocols into the CHO-M
  • Cutting edge single cell cloning technologies
  • Assessment of lead RCB in ambr15 bioreactor system, including early quality check for your molecule and cell line
  • Assessment of robust quality and transgene sequence verification
  • Stability studies

Building upon the SUREtechnology Platform, our leading mammalian CLD services, vertically integrated as part of our CDMO integrated offering, allow us to further streamline your path to GMP with dedicated offerings matched to your molecule.

 

Learn More: Cell Line Development

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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. 

 

Learn More: Genomic Analysis

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.

 

Learn More: 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.

 

Learn More: Analytical Development

Formulation Development

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. 

 

Learn More: Formulation

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. 

 

Learn More: Clinical Manufacturing

 

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.

 

Learn More: Commercial Manufacturing

Publication: 

Application of platform process development approaches to the manufacturing of Mabcalin™ bispecifics

In their article, the authors evaluate a high-yield manufacturing platform using Mabcalcin™ molecules (which consist of Anticalcin® proteins fused to an IgG), assessed to commercially-relevant scales1 This platform approach demonstrates a fast, optimized route to process confirmation that aligns  with classical monoclonal antibody (mAb) approaches when it comes to timelines and overall cost.

Whitepaper:

Delivering on the Promise of Bispecifics

Given the complexity of bsAbs, a  development platform for these needs three key features to be sufficiently robust: Stable and high expression of bsAbs, straightforward early screening, and a robust cell line that can handle stressors. Furthermore, advancing bsAbs into the clinic requires process development, analytical methods, and scale-up for cGMP manufacturing. Our leverageable, integrated workflow generates high-quality clinical bulk drug substances under accelerated timelines.

Article on Labiotech.eu:

Overcoming the Challenges of Bispecific Antibody Production

In a recent article published on Labiotech.eu, Séverine Fagète, Vice President of Mammalian Cell Line Development at KBI Biopharma, details the innovative and advanced approach she and her team take to overcome common obstacles and bottlenecks in bsAb development and production. KBI Biopharma's strategic approach has been applied to more than 25 bsAbs, yielding up to 99% heterodimers and paving the way for efficient production of bsAbs for clinical use.