Analytical Development

  • Analytical Development 1
  • Analytical Development 2
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.).

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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
    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
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. (12)

  • 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 ...
  • Clinical Manufacturing

    Product Clinical Manufacturing

    KBI Biopharma offers a broad range of cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Our capabilities include reliable manufacturing for preclinical and clinical supply.

    KBI’s experienced team produces high-quality therapeutics and vaccines thro...
  • cGMP Mammalian Production

    Product cGMP Mammalian Production

    KBI offers global cGMP Mammalian Production, and organizational highlights include:  • First CDMO to implement 2,000L single-use cGMP operations • High throughput single-use technology (AKTA Ready XL, 2500L SUM, 12m2 TFF) • A broad range of cGMP biologics manufacturing services from pre-clinical thr...
  • cGMP Microbial Production

    Product cGMP Microbial Production

    The KBI Boulder facility has extensive experience in generating E. coli based expression systems for high-level expression of recombinant proteins, typically using T7 expression in the BL21(DE3) strain as a platform. Following demonstration of expression in shake flasks, fermentation development ...
  • Commercial Mass Spectrometry Services

    Product Commercial Mass Spectrometry Services

    Mass spectrometry is among the most powerful analytical techniques available for protein characterization. KBI’s state-of-the-art mass spectrometry core facility delivers unparalleled structural characterization services to our clients. 
    Our expert team brings decades of experience in protein and p...
  • Cell Therapy Services

    Product Cell Therapy Services

    KBI's Cell Therapy team, located in The Woodlands, TX, has managed a fully functional manufacturing facility supporting cell therapies and developing therapies under IND since 2001. Our team has substantial expertise and knowledge in cellular therapies' manufacturing, process development, and regulato...
  • PUREplatform™

    Product PUREplatform™

    At KBI Biopharma, our PUREplatform is everything you need to make a protein. Containing plasmids, strains, media, and a fermentation process that all fit together into a service package catered to your needs. 

    • Features our PUREcoli™ cell line, our proprietary high-producing E. coli ce...
  • SUREmAb™

    Product SUREmAb™

    Built on the SUREtechnology Platform, SUREmAb optimizes monoclonal antibody (mAb) development and manufacturing processes, fast-tracking the path to clinic and market. • Fast-tracked for efficiency and speed, taking you from DNA transfection to GMP drug substance in 11 months • Comprehensive mAb develop...
  • SUREtechnology Platform™

    Product SUREtechnology Platform™

    With our advanced gene technology and proprietary cell line, we are able to overcome common bottlenecks that come with developing high-performance mammalian cell lines, especially when expressing novel molecule types.

    Mammalian cells are the gold standard for biologics development. 

    ...

KBI Biopharma Inc. resources (14)

  • News Aaron Pilling Discusses the KBI PUREplatform Launch

    KBI's PUREplatform™  is a game-changing microbial expression offering that redefines biopharmaceutical manufacturing.

    Hear from Aaron Pilling, Ph.D., Senior Director of Process Development, as he discusses the KBI PUREplatform, a premium microbial CLD platform that delivers unmatched efficiencies. 
    15 Aug 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™.

  • News Executive Team - About KBI & Selexis Operational Consolidation

    Hear from our parent company JSR Life Sciences and our executive team about the operational consolidation of KBI and Selexis as one organization. Get their perspective on how this brings us one step further on the path of becoming the icon of next-generation CDMOs and how the benefits translates for our partners.
    15 Aug 2023
  • Delivering on the Promise of Bispecifics: Antibody Development

    Whitepaper Delivering on the Promise of Bispecifics: Antibody Development

    A breakthrough approach to bispecific production via streamlined workflow; cell line development to GMP manufacturing.
  • KBI Strengthens Leadership With Executive Appointments

    News KBI Strengthens Leadership With Executive Appointments

    KBI announces four recent executive appointments to continue its momentum and vision of becoming a next-generation CDMO. Joining the company are Tony Fraij, COO; Shaguna Seth, Chief of Staff and Global PMO Leader; Katie Edgar, SVP of Corporate Strategy and Alliance Management; and Sarah Wakefield, SVP, Corporate Communications.
    15 Aug 2023
  • Titration Curve Modeling in Bioassay Potency Method Development

    Video Titration Curve Modeling in Bioassay Potency Method Development

    In the contract laboratory environment, the time constraint is ever-present and works against both the contract lab and the client or sponsor. This is especially true for the cell-based potency testing teams, where the assays have an infinite number of variables ranging from optimal growth conditions to the generation of the ideal titration curve to accurately measure any effect on the targeted mechanism of action. To overcome this ever-present hurdle, the Cell-Based Assay Team at KBI utilizes a titration curve modeling tool to effectively predict the cellular response to an agonist or antagonist.

  • News Unveiling KBI PUREplatform™, a Game-Changing Microbial Offering

    KBI announced the launch of KBI PUREplatform™, a premium microbial cell line development platform that features unmatched efficiencies for biopharmaceutical production. A culmination of decades of expertise, the platform addresses challenges, empowering customers to bring products to market cheaper and easier.
    9 Aug 2023
  • KBI Appoints Marykay Marchigiani CFO and Sigma Mostafa, Ph.D., CSO

    News KBI Appoints Marykay Marchigiani CFO and Sigma Mostafa, Ph.D., CSO

    Durham, North Carolina (May 10, 2023)  – KBI, a JSR Life Sciences company, today announced the appointment of Marykay Marchigiani as Chief Financial Officer and Sigma Mostafa, Ph.D., as Chief Scientific Officer. The additions will allow KBI to fulfill its growth strategy of becoming a next-generation CDMO.
    9 Aug 2023
  • KBI Appoints David Stewart Site Head of Durham cGMP Facility

    News KBI Appoints David Stewart Site Head of Durham cGMP Facility

    Stewart has more than two decades of biotech leadership experience and a proven record of delivering best-in-class supply for patients. He will oversee all operations at Patriot Park, Durham, North Carolina, driving deliverables for KBI’s global biopharmaceutical customers.

    9 Aug 2023
  • KBI Geneva Inaugural FIH Batch Released Five Months After Opening

    News KBI Geneva Inaugural FIH Batch Released Five Months After Opening

    In late 2022, KBI successfully released its inaugural FIH manufacturing batch in compliance with cGMP standards in its recently expanded Geneva mammalian cell manufacturing facility. This important milestone demonstrates the capabilities of KBI, allowing clients to accelerate clinical research timelines.
    8 Aug 2023
  • KBI Biopharma Announced as 2023 ISPE Facility Finalist

    News KBI Biopharma Announced as 2023 ISPE Facility Finalist

    KBI Biopharma is thrilled to announce that its Patriot Park facility has been named a finalist in the 2023 ISPE Facility Of The Year Aawards (FOYA) in two categories: operations and pharma 4.0
    8 Aug 2023
  • Subcontract with Mapp on Sudan ebolavirus Treatment

    News Subcontract with Mapp on Sudan ebolavirus Treatment

    Following the recent Sudan ebolavirus outbreak in Uganda, KBI is providing emergency support through global production efforts.KBI announced it entered into a subcontract with Mapp for the continued development and manufacturing of MBP134, an experimental combination monoclonal antibody treatment for Sudan ebolavirus.
    8 Aug 2023
  • KBI Biopharma and Selexis SA Appoint J.D. Mowery as CEO

    News KBI Biopharma and Selexis SA Appoint J.D. Mowery as CEO

    KBI Biopharma and Selexis, announced in April 2023 the appointment of J.D. Mowery as CEO. Widely respected as an innovative biotech leader with a nearly 25-year track record of successfully inspiring colleagues and building organizations, J.D. will lead KBI and Selexis into becoming a leader in the next CDMO generation.
    8 Aug 2023
  • Streamlined Development for Efficient Production of Bispecific Molecules: Connect to Frankfurt on-demand

    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.  
    7 Oct 2022