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Mammalian CDMO Services 

Fine tune to your molecule.
Maximize your success.

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A Match for Breakthrough Molecule Types

KBI is redefining how mammalian-based expression is used throughout the development and manufacturing of new biologics.

Trusted Experience

 

30+ years of world-class innovation, pioneering exceptional cell line development

Scientific Innovation

 

Leading innovation with new approach in cell line development and process development 

Specialized Antibody Expertise

 

Expertise in high-value bispecific and multispecific antibody production

Molecule Specific

 

Robust and versatile platforms and collaborative workflows for difficult-to-express proteins and bispecific antibodies

Efficient Manufacturing

 

Cost-effective, simplified workflow for mAb development and manufacturing

Full-scope mammalian programs with the depth of experience to
make the complex possible

 

KBI Biopharma has engineered an advanced proprietary CHO-based mammalian cell line to address the growing complexity of therapeutic proteins. By integrating premium cell line development with deep analytical, process, and formulation expertise, KBI delivers a comprehensive mammalian CDMO workflow that supports reliable expression of a wide range of biologics from early development through commercialization.

 

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Mammalian Cell Line Development

As part of our mammalian CDMO solutions, our mammalian cell line development services leverage the Selexis® SUREtechnology™ Platform, 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:

  • Codon optimization: genetic engineering and signal peptide matching for optimal expression
  • 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 SUREtechnologyTM 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.

  

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

Mammalian 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.

 

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.

 

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Analytical Mammalian 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.

  • 4000+ analytical projects
  • 400+ 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.

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200
+

Clinical Programs

450
+

INDs

(15+ Annual Supported)

13

Commercial Products

First-In-Human (FIH) Highlight

Navigating the growing complexity of new therapeutic proteins requires more than just a standard workflow—it requires an engineered advantage. At KBI Biopharma, we’ve developed an advanced CHO-based mammalian cell line designed specifically to break through the industry's toughest expression bottlenecks.

End-to-End Excellence

We unite premium cell line development with world-class analytical, process, and formulation expertise. From your first sequence to commercial manufacturing, we provide a seamless, integrated journey for any biologic molecule.

  • Integrated Workflow: Streamlined transition from CLD to clinical and commercial scales.

  • Global Scale: Access world-class facilities and expert teams across the globe.

  • Future-Proofed: Sustained excellence for every molecule, at every stage.

 

Integrated Mammalian-Based Workflow for Phase I Programs

 

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 Share your contact details to connect with our team, and an expert will follow up to discuss how we can support your mammalian development and manufacturing needs. 

Flexible, Knowledgeable, and Proven


About KBI Biopharma

KBI Biopharma is a leading global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. With each of our 1400+ customer partners, we work closely to personalize and accelerate drug development programs. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, we deliver robust process development and clinical and commercial cGMP manufacturing services for mammalian and microbial. Recognized for quality manufacturing, we help clients advance drug candidates into the clinic and beyond.

Science Driven. Customer Focused.