KBI's Approach to Purification Development
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.
By leveraging experience gained from developing processes for over 75 biomolecules, KBI has perfected standard approaches for developing processes for various classes of proteins including monoclonal antibodies.
This experience has also allowed KBI to develop a tool box that facilitates resolving unique protein purification challenges in a timely manner.
KBI’s exceptionally strong protein characterization capabilities, including conformational and structural analyses via biophysical techniques and mass spectrometry, provide “fast insight” into a client’s unique product, enabling a development strategy that accelerates timelines and reduces risk.
Having integrated process development and analytical development teams ensures that a broad perspective is used to achieve product quality goals for each program.
Our goal is to eradicate HIV. In order to do that you need a lot of “Shots on Goal”. Working with KBI and their talented team of Scientists, they have developed a platform process that works for producing/purifying an array of these complex glycoproteins with plans to bring them to the clinic in the very near future.
Thomas N. Denny, MSc, M.Phil, Professor of Medicine, Duke University
KBI’s Purification Capabilities
Highly Evolved Downstream mAb Platform
Downstream platform designed to provide robust impurity clearance despite diverse mammalian cell clones and cell culture harvests
Extensive experience in expedited process development for monoclonal antibodies
Development of Process Platforms for Non-mAbs
Experience with downstream platform development for vaccine targets
Application of defined platform for expedited development of follow-on molecules
Establishment of Bespoke Downstream Processes
Integration of process development and analytical development to customize downstream unit operations
Inclusion of selective washes to enhance impurity clearance
Process Characterization, Scale-down Validation & In-process Control Strategy
Application of QbD principles to define process design space
Qualification of scale-down models
Identification of important process parameters through FMEA analysis
Execution of single variable experiments to response surface DOEs to enable classification of process parameters as key or non-key
Understanding of Protein Interactions with Chromatographic Surfaces & Influence on the Downstream Process
Utilization of multimodal chromatography to increase robustness of process impurity clearance
Evaluation of target protein biophysical and biochemical attributes to guide downstream process development
Viral Clearance Validation Studies
Implementation of ICH Q5A guidelines
Design, planning and execution of Phase I and Phase III viral clearance studies
Execution of greater than 15 studies in a given year
Established relationship with third-party viral clearance labs to ensure successful studies and to meet expedited IND filing timelines
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