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Expert purification process development for biotherapeutics

Developing Purification Process to Support New Biologics

Applying Deep Knowledge and Experience to the Science and Practice of Biopharmaceutical Drug Development


By leveraging the experience gained from developing processes for more than 75 unique biomolecules, KBI has perfected standard approaches for process development across various classes of proteins, including monoclonal antibodies.

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

This experience has also allowed KBI to develop a toolbox that promptly resolves unique protein purification challenges.

KBI’s robust 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.


KBI's Phase-Specific Lifecycle Approach to Analytics

Having integrated process development and analytical development teams ensures a broad perspective to achieve product quality goals for each program.

  • Industry-leading scientific methodologies in high-throughput process development
  • 40+ annual programs ranging from First in Human (FIH) process development to late-stage process development, characterization, and validation
  • 15+ investigational new drug (IND) submissions supported annually

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 more than 100 studies

  • 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

Ready to Learn More? Get in Touch with our Team.


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