8
Oct
2024

KBI Biopharma

Exhibitor at CPHI Milan 2024 stand 5B89, Contract Manufacturing and Services & stand 5F91, Contract Manufacturing and Services
About Us

KBI Biopharma, a JSR Life Sciences company, 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 its 500+ client partners, KBI works closely to personalize and accelerate drug development programs. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, KBI delivers robust process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. Recognized for quality manufacturing, KBI helps clients advance drug candidates into the clinic and beyond. KBI serves its global clients with multiple locations in Europe and the USA. www.kbibiopharma.com.

Selexis SA, a JSR Life Sciences company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global client partners have utilized Selexis technologies to advance more than 160 drug candidates in preclinical and clinical development and manufacture ten commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks. More information is available at  www.selexis.com

Categories
  • US
  • 2015
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company
CMO/CDMO
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Primary activities
Biopharmaceutical
Contract Manufacturer
Contact info
Event information
CPHI Milan 2024
  • 08 Oct 2024 - 10 Oct 2024
  • Fiera Milano, Italy
  • Visit us at stand 5B89, Contract Manufacturing and Services

Products Featured at CPHI Milan 2024

  • 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...
  • 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 ...
  • 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. 

    ...
  • Biologic Drug Substance & Drug Product Formulation

    Product Biologic Drug Substance & Drug Product Formulation

    To date, KBI has conducted over 130 successful protein, peptide, and vaccine formulation development programs. 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, chemic...
  • cGMP Protein and Antibody Purification

    Product cGMP Protein and Antibody Purification

    KBI Biopharma has extensive experience developing purification processes for a wide variety of biotherapeutics, including: -Monoclonal antibodies-Bispecific antibodies -Enzymes -Fc fusion proteins -PEGylated proteins -Complex glycoproteins KBI supports 40+ annual programs ranging from FIH (First-in-Huma...