Process Development

Process Development
Product Description

KBI Biopharma delivers end-to-end process development services for both mammalian and microbial-based biologics, enabling efficient scale-up and robust transfer to cGMP manufacturing. Our team supports the full development cycle, from early-stage feasibility and small-scale protein production through upstream and downstream process optimization, characterization, and scale-down validation studies. With expertise spanning CHO and E. coli platforms, KBI Biopharma helps clients address molecule-specific challenges while reducing development timelines and cost. Our integrated approach combines scientific rigor, flexible project execution, and deep biologics experience to ensure high-yield, high-quality processes that are ready for GMP manufacturing and regulatory expectations. Whether optimizing legacy processes or developing new ones from scratch, KBI is the partner of choice for biopharma innovators.

KBI Biopharma Inc.

  • Country/Region:
    United States
  • On CPHI since:
    2015
  • Employees:
    1000 - 4999
Company types
Biopharmaceutical company
CMO/CDMO
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Primary activities
Biopharmaceutical
Contract Manufacturer
Specifications
  • Supplied from
    Switzerland; United States

KBI Biopharma Inc.

  • Country/Region:
    United States
  • On CPHI since:
    2015
  • Employees:
    1000 - 4999
Company types
Biopharmaceutical company
CMO/CDMO
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Primary activities
Biopharmaceutical
Contract Manufacturer

More Products from KBI Biopharma Inc. (13)

  • SUREmAb
  • Targeted HCP
  • Transpoease
  • Analytical Development

    Product Analytical Development

    When your program demands precise answers, our over two decades of experience tackling complex challenges deliver rapid, dependable results powered by profound scientific expertise. Your analytical challenges demand comprehensive lifecycle support with customized solutions. Whether addressing comple...
  • 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-Human)...
  • Argonaut
  • Cell Line Development

    Product Cell Line Development

    Cell Line Development
  • Cell Line Development Rebate

    Product Cell Line Development Rebate

    Cell Line Development Rebate
  • First in Human
  • Gantt Chart
  • Manufacturing

KBI Biopharma Inc. resources (12)