Conquer Complexities With Advanced Mass Spectrometry

Expertise In Analytics For Comprehensive Biotherapeutic Development, Manufacturing, And Downstream Processing

• High Selectivity
• High Sensitivity
• High Specificity
• High Resolution
• Backed by Decades of Experience

Expert Support For Development And Characterization

Supporting Robust Data Requirements At Every Phase Of The Project Cycle

The clinical and commercial success of biotherapeutics hinges on the development of robust, reproducible, analytical methods. High-resolution mass spectrometry is a powerful tool used at KBI Biopharma for analytical strategies concerning complex samples. In support of biotherapeutics across the board, KBI's Mass Spectrometry Core Facility has championed the characterization and management of proteins, active pharmaceutical ingredients (APIs), and impurities through identification, characterization, assessment, and quantitation. At KBI, we are true partners working hand-in-hand with clients to conquer complexities and develop lasting solutions to the analytical challenges that come with the development of biologics.

Full Scope Support

From Early-Stage Samples To Highly Purified Drug Substances

At KBI Biopharma, we leverage high-resolution LCMS systems coupled with state-of-the-art data processing solutions to offer comprehensive analytical capabilities and services. From sequence verification and developability data (to support proof-of-concept) to initial structure characterization (to support IND filing) to comprehensive impurity characterization (to support BLA licensure), KBI delivers unparalleled structural characterization services. We support:

• Small molecules, including residual screening
• Monoclonal antibodies, including full-length mAbs, domain antibodies, antibody conjugates, and antibody fragments
• Fusion proteins
• Multi-specific antibodies & proteins
• Protein vaccines
• Biosimilars, Biobetters, and Biosuperiors
• Recombinant protein drugs
• Proteomic workflows
• Peptide and disulfide mapping
• N-glycan profiling
• Host cell protein analysis
• PEGylation site and occupancy analysis
• Product and process-related impurity analysis, including impurity characterization
• De novo sequencing
• Varied analysis services, including point mutations, AAVs, ADCs, oligonucleotides, and nucleic acids (among others)
• Cell line profiling
• Proof-of-concept
• IND filing and BLA licensure
• With non-GMP and GMP services

KBI has deep expertise in the characterization and quantitation of APIs and impurities to deliver exceptional, reliable results that keep projects on track.