Analytical Development

Product Description

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 glycosylated proteins, protein vaccines, PEGylated proteins, conjugates, peptides and other proteins. 
 
KBI expertise includes HPLC, CE, ELISA, UV-Vis, mass spectrometry, light scattering, biophysical characterization (DSC, CD, FTIR, fluorescence), binding assays (ELISA, Biacore, Forte Bio), glycan analyses, cell based assays, and others. We routinely provide STAT analytical support for process development (e.g., DOE sample analysis) and manufacturing (HPLC and other methods for titer, purity, etc.).

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
Specifications
  • Details
    Comprehensive services at every phase of the project cycle
  • Model
    https://www.kbibiopharma.com/capabilities/services/analytical-process-development
  • Supplied from
    Belgium; United States
  • Measured In
    piece

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

More Products from KBI Biopharma Inc. (4)

  • Cell Line Development

    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. ...
  • Process Development

    Product Process Development

    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 c...
  • 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 (3)

  • 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? 
  • 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™.

  • Video Rapid Timeline to Tox Starting with KBI Biopharma's SUREtechnology Platform™, Powered by Selexis

    KBI Biopharma’s cell line development services, powered by Selexis®, have been at the forefront of innovation for the last two decades. We are introducing the latest version of proprietary SURE CHO-M technology, which uses a transposase-based semi-targeted integration method and provides high productivity and stable cell lines for therapeutic protein production, while exhibiting a doubling time of 15-17 hours. Using this transposase-based cell line, KBI Biopharma is now delivering tox material in as little as 6 months from transfection. The tox material will be generated with the top 6 clones. In addition, we are introducing an afucosylated host cell line for the generation of therapeutic proteins without any fucose residues. KBI Biopharma is also introducing a completely new targeted integration technology developed by our own next-generation sequencing software. This panel of new cell line offerings surpasses customer expectations and is set to establish new industry standards.