With Advanced Mass Spectrometry
Expertise In Analytics For Comprehensive Biotherapeutic Development, Manufacturing, And Downstream Processing
Backed by Decades of Experience
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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.
An Innovative Approach to See More and Dig Deeper
Conquering complexities, together. By combining cutting-edge technology, close collaboration, and keen insight, we create lasting solutions to analytical challenges.
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
- 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.
Mass Spectrometry for Complex Biotherapeutics: Q&A with KBI's Mass Spectrometry Team
We recently sat down with Michael J. Nold, Ph.D., Senior Director of KBI’s Mass Spectrometry Core Facility in Durham, North Carolina, to discuss how advanced Mass Spectrometry plays a significant analytical role in the characterization and quantitation of APIs and impurities in complex biotherapeutics.
Using Advanced Mass Spectrometry for Characterization and Quantitation of APIs and Impurities in Complex Biotherapeutics
Advanced analytical capabilities, including mass spectrometry, are critical for the characterization of active pharmaceutical ingredients (APIs) and managing a diverse population of impurities. This allows for effective mitigation of safety risks and ensures product quality.