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.

Case Study: Using Selective Washes to Solve a Purification Issue

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.

Case Study: A Comparison of Multimodal Chromatography Resin

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
Purification KBI akta avant (click to enlarge)

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

  • Learn More: Whitepaper | Evolution of mAb Downstream Platforms

Development of Process Platforms for Non-mAbs

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

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

  • Learn More: Publication | Viral clearance for biopharmaceutical downstream processes