Process Development

Process Development
Product Description

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 cGMP manufacturing.

KBI's process development activities cover the full development cycle. We support early-stage discovery efforts through small-scale protein production to fully-integrated, comprehensive process development programs leading to cGMP manufacturing to process characterization and scale-down validation studies. We take pride in our deep knowledge and experience in the science and practice of biopharmaceutical drug development. Our abiding customer focus and situational flexibility combined with a solid scientific base enable us to be the ideal partner for our clients' biopharmaceutical process development needs.

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KBI Biopharma Inc.

  • US
  • 2015
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company
CMO/CDMO
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Primary activities
Biopharmaceutical
Contract Manufacturer
View company profile
Categories
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Specifications
  • Details
    Supporting Process Development for both Mammalian and Microbial Expression Systems
  • Model
    https://www.kbibiopharma.com/capabilities/services/fermentation-process-analytical-development
  • Supplied from
    Switzerland; United States
  • Measured In
    piece
More specifications Fewer specifications

KBI Biopharma Inc.

  • US
  • 2015
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company
CMO/CDMO
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Primary activities
Biopharmaceutical
Contract Manufacturer
View company profile

More Products from KBI Biopharma Inc. (4)

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    Product Cell Line Development

    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. ...
  • Analytical Development

    Product Analytical Development

    With top expertise in protein analytics, KBI has successfully completed over 3300 analytical projects for more than 300 customers and more than 130 distinct molecules.


    Our experience includes antibodies (IgG1, IgG4, IgM, FAb, ADC, Fc fusion), enzymes, cytokines, growth factors, highly glycosylat...
  • Formulation Development

    Product Formulation Development

    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...
  • Characterization

    Product Characterization

    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 Inc. resources (2)

  • CPHI Barcelona 2023: Tackling the Pharma Talent Precipice – Part 2

    News CPHI Barcelona 2023: Tackling the Pharma Talent Precipice – Part 2

    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? 
    15 Nov 2023
  • Navigating a New Standard in Microbial Protein Expression

    Whitepaper Navigating a New Standard in Microbial Protein Expression

    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™.