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KBI Biopharma Inc. offer service "Formulation Development"

Basic Information

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Trade Type

Offer Service

Service Name

Formulation Development

Service Provider(s)

Specifications

  • Stability Indication: Establishes protein intrinsic properties through thermal, physical, chemical and conformational stability characterization.
  • Excipient Selection: Uses statistical design-of-experiment (DOE) to evaluate excipient and formulation-component interactions affecting protein stability.
  • Dosage Form: Develops robust, data-driven biologics formulations as a global analytical, process and formulation development partner.

Other Information

Additional Description:

This formulation development approach pairs two complementary disciplines: building a comprehensive understanding of a protein's intrinsic properties and stability through thermal, physical, chemical and conformational characterization, and evaluating interactions and key effects on protein stability using statistical design of experiments (DOE). This lets KBI develop robust formulations by removing uncontrolled stability variables, focusing on therapeutic performance and clinical outcomes, drawing on more than 130 successful protein, peptide and vaccine formulation development programs and delivering stable liquid formulations across protein concentrations from above 1 mg/mL to 200 mg/mL.
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