Technical Data
2 Oct 2022

Corporate Overview

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KBI offers 18 years of pressure-tested quality systems and regulatory compliance. Our global cGMP quality system supports clinical and commercial biologics with our team of experts manufacturing and releasing hundreds of cGMP product lots.
KBI and Selexis provide cell line transfection through cGMP drug manufacturing with Selexis’ specialized high-titer mammalian cell line development technologies and services and KBI’s cGMP bulk drug manufacturing for clinical and commercial requirements. 

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KBI Biopharma Inc.

  • US
  • 2015
    On CPHI since
  • 1000 - 4999
Company types
Biopharmaceutical company
Generics/Biosimilars Manufacturer
Primary activities
Contract Manufacturer

Other Content from KBI Biopharma Inc. (12)

  • News Streamlined Development for Efficient Production of Bispecific Molecules: Connect to Frankfurt on-demand

    In this Connect to Frankfurt session, Séverine Fagète, VP, Cell Line Development Services at Selexis (Geneva, Switzerland), and Brandon Brino (Durham, USA), Process Development Scientist and Group Leader at KBI Biopharma, present an overview of a streamlined process for the production of bispecific molecules.  
  • News Application of Inline Variable Pathlength Technology for Rapid Determination of Dynamic Binding Capacity in Downstream Process Development of Biopharmaceuticals

    iotechnology Progress:Volume 38, Issue 2, March/April 2022  

    Rashmi P. Bhangale, Rui Ye, Thomas B. Lindsey, Leslie S. Wolfe.

    KBI's Downstream Process Development Team at our Durham, North Carolina location had their work published in the March/April 2022 issue (Volume 38, Issue 2) of Biotechnology Progress.

  • Technical Data Mammalian Offering Overview

    KBI was the first CDMO to implement the 2000L scale single-use bioreactor. We deliver cGMP drug substance supplying first-in-human to commercial.

  • News Faster Determination of Dynamic Binding Capacity – Q&A With KBI’s Scientific Team

    Biopharmaceuticals are a significant growth area for the pharmaceutical industry, as these therapeutics can address unmet medical needs through novel mechanisms of action. A wide range of biopharmaceuticals is currently in clinical development, including monoclonal antibodies (mAbs), recombinant proteins, and Fc fusion proteins. These biomolecule-based therapies can offer significant therapeutic benefits and have numerous applications in oncology, immunology, neurology, and inflammation-based disorders, among others.
  • Technical Data Analytical Overview

    KBI’s extensive analytical capabilities help our clients develop lasting solutions to analytical challenges faced during the development of biologics.

  • Technical Data Microbial Offering Overview

    Our unique expertise enables us to express “difficult-to-refold” products. Using scalable, high-density microbial fermentation, our clients benefit from shorter development at each phase and subsequently lower cost.

  • Technical Data Cell Therapy Offering Overview

    KBI has substantial expertise and knowledge in process and analytical development, manufacturing, and regulatory aspects of cellular therapies and maintains strong relationships with the US FDA and Health Canada.

  • Whitepaper Delivering on the Promise of Bispecifics: Antibody Development

    A breakthrough approach to bispecific production via streamlined workflow; cell line development to GMP manufacturing.
  • Video Geneva Facility Tour

    Experience The Power Of KBI And Selexis In Geneva.

    One premier location for cell line development, process development, and manufacturing. Built for end-to-end services, and globally known for tackling some of the most challenging biologics projects.

    That's the power you have with KBI and Selexis in Geneva. That's the power of together.
  • Video KBI Biopharma Expanding in Europe

    One premier location for cell line development, process development, and manufacturing. Built for end-to-end services, and globally known for tackling some of the most challenging biologics projects.   

    That's the power you have with KBI and Selexis in Geneva. That's the power of together.  
  • Video Streamlined Development For Efficient Production Of Bispecific Molecules Using An Integrated Platform Process

    This webinar will demonstrate 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.

    Did you enjoy this session? If so, you might like to visit our Connect to Frankfurt platform, where you can browse our collection of 30+ on-demand webinars and learn about our upcoming CPHI Frankfurt event, taking place 1-3 November in Frankfurt, Germany.

    Bringing together the global supply chain under one roof, CPHI Frankfurt puts you at the heart of pharma. Can’t attend in person? You can access many of the event offerings online! Browse our exhibitor list, arrange meetings, view on-site content and network – all from home.

    Click here to register

  • Webinar Utilization of Titration Curve Modeling in Bioassay Potency Method Development

    Contract laboratories are time constrained which affects provider and client. This is especially notable for Cell Based Testing Teams, where the assays vary due to growth condition variability and the plotting of titration curves to accurately measure any effect on the targeted mechanism of action. To overcome this, the Cell Based Assay Team at KBI uses a modeling tool to predict the cellular response to an agonist or antagonist.