HCP Clearance | rProteins

Designed to control complex antibody and recombinant protein impurity profiles
without compromising recovery, product quality or process robustness

1000

HCP Species mapped across 

CHO feeds 

0 %

Captured by ChromaGenix 

resin

> 1

HCP LOG REDUCTION

The HCPs that matter most are often the hardest to remove.

Protein A capture and established polishing operations can remove substantial bulk HCP burden. Yet specific proteins may continue through the process because they share properties with the target molecule, associate with the product or resist broad physicochemical separation.

These residual species may represent only a small proportion of total HCP while creating disproportionate concerns around:

  • product stability and degradation
  • process consistency
  • batch-to-batch variability
  • impurity-control confidence
  • downstream development burden

Understanding which HCPs remain, why they persist and how consistently they are controlled provides a stronger basis for downstream process decisions.

Higher titers changed the impurity landscape: HCP clearance is the new bottleneck

Downstream purification must now contend with a more diverse and abundant HCP population, persistent species that co-purify with product, and a regulatory environment that demands both lower total HCP and specific clearance data for high-risk proteins.

01

Bulk HCP Reduction Is No Longer Sufficient

Regulatory scrutiny has shifted from total HCP load to specific, high-risk host cell proteins. Generic polishing steps that reduce overall burden may still fail to clear the species that matter most for safety and immunogenicity.

02

Polishing Step Inconsistency at Scale

CEX and AEX performance varies meaningfully across molecule platforms and upstream conditions. Steps that clear reliably in development often show variability at pilot or commercial scale, requiring costly re-optimisation.

03

Yield–Purity Trade-offs Remain Unresolved

Aggressive HCP clearance typically comes at a yield penalty. Teams are routinely forced to accept sub-optimal compromise positions because no single polishing tool delivers both high selectivity and high recovery simultaneously.

04

Multi-Step Workflows Drive Up Cost and Risk

The requirement for multiple polishing steps to achieve target purity profiles directly impacts manufacturing cost, process complexity, and development timelines — creating a strong economic case for step consolidation.

A Purpose-Designed Impurity Control Resin

ChromaGenix goes beyond bulk impurity reduction by targeting persistent and high-risk HCP subsets while preserving product recovery and ease of fit into established downstream workflows. 

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Target the HCPs That Matter

Move beyond total HCP reduction toward selective removal of persistent, product-associated and process-relevant species identified through proteomics.

Preserve Valuable Product

True flow-through operation: the target mAb passes through unbound while persistent HCPs are selectively retained. No elution step, no yield penalty.

Selectivity Beyond Charge-Based Polishing

Our ligand ensemble targets the full spectrum of molecular weight, isoelectric point, and hydrophobicity, removing HCP populations that evade conventional charge-based polishing.  

Platform-Ready Robustness

Improve clearance consistency, reduce polishing burden and support more robust purification for diverse antibody and recombinant protein feeds. 

Solving the Persistent HCP Challenge in rProtein Purification

This application falls under our NAVIGATE program,  connecting you with process expertise, new purification technologies, new insights and collabration opportunities to shape and implement a GMP-ready solution.

PROGRAM CHAIR

Professor Stefano Menegatti

NORTH CAROLINA STATE UNIVERSITY | CHROMAGENIX

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Chris Major

CEO

Chris is responsible for identifying investment opportunities, assessing strategic fit within the portfolio, and supporting growth-related operational initiatives. A serial entrepreneur with over 20 years of bioprocessing experience, he has deep expertise across upstream and downstream technologies. Prior to BioProcess360, he founded and led the Purolite Bioprocessing division, growing it from zero revenue in 2015 to $80M in six years. The business was acquired by Ecolab (NYSE: ECL) in 2021 for $3.7BN. Earlier, Chris helped pioneer single-use technology at WAVE Bioreactors, later acquired by GE Healthcare (now Cytiva), and held senior roles at GE and Merck Millipore. He holds an MSc in Biotechnology and attended Harvard Business School. Outside work, Chris enjoys biking, paddleboarding, live music, and spending time with his two daughters.