KBI Biopharma

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KBI Biopharma

Standalone Quote Requests and Study Types

Please select one of our standalone services below by clicking "Request Quote".

Rapid Analytics
Rapid Analytics

Ad-hoc analytical testing including mass spectrometry, particle forensics, analytical ultracentrifugation, biophysical characterization testing.Learn More


Release and Stability
Release and Stability

Release and stability programs reliably evaluate the quality, safety, and efficacy of biotherapeutics at release and during long term storage.Learn More


Method Establishment
Method Establishment

Comprehensive analytical development services at every phase of the project cycle.Learn More


Formulation
Formulation

Developing robust, optimized formulations to maximize therapeutic performance and clinical outcomes.Learn More


Compatibility and In-Use Stability
Compatibility and In-Use Stability

Evaluation of critical quality attributes (CQAs) using selected drug product administration clinical protocols to minimize patient risk and improve clinical outcomes.Learn More


Comparability
Comparability

Analytical comparability studies rigorously assess CQAs from pre- and post-change lots for a reliable comparison of the product quality, safety, and efficacy.Learn More


Product and Process Characterization
Product and Process Characterization

Comprehensive range of biophysical, biochemical, and biological characterization services including high resolution mass spectrometry, cell-based assay, particle forensics, and biophysical core technologies.Learn More


Similarity
Similarity

Biosimilar licensure requires demonstration of bioequivalence to a reference biologic. Similarity studies assess physical, chemical, and biological properties to support claims of equivalent safety and efficacy.Learn More


Microbial Cell Line Development
Microbial Cell Line Development

Microbial expression that ensures product quality, safety, and titer across proteins and at scale.Learn More


Mammalian Cell Line Development
Mammalian Cell Line Development

CHO-based mammalian expression for robust and versatile cell line development with high productivity and performance, matched to your molecule and needs.Learn More


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