HCP reduction observed in HEK293-derived viral vectors
LRV under selected conditions
Higher AAV recovery observed with combined HCP clearance + affinity capture workflow
Move beyond non-selective polishing in viral vector processes
The full data set, development data and process rationale Complete the short form to download the PDF.
- Core-shell purification mechanism: How the size-exclusion shell (≈400–700 kDa cutoff) excludes vectors while capturing HCPs in the resin core
- Serotype coverage: Flow-through HCP removal observed across multiple AAV serotypes from HEK293 cells, without a separate development cycle per serotype.
- Optimized architecture: Up to 3.5-log HCP removal from HEK293 fluids after pore-size optimization and core-shell combination.
- Process economics: AAV recovery across 10 consecutive cycles, comparing affinity capture alone versus the combined pre-affinity workflow.
Professor Stefano Menegatti
NORTH CAROLINA STATE UNIVERSITY | CHROMAGENIX
Why this session exists
As viral vector titers and manufacturing demand increase, impurity burden is becoming a major downstream constraint. HCPs, residual DNA and process debris can affect capture performance, polishing efficiency, recovery consistency and resin lifetime. Unlike proteins and mAbs, vectors are large, recovery-sensitive products produced in impurity-rich HEK293 systems which require specialized strategies.
The ChromaGenix approach
ChromaGenix is exploring a dedicated viral vector impurity-control step positioned before or after affinity capture. A core-shell resin excludes large vector particles from the core while capturing smaller HCPs and nucleic acids to remove impurities in flow-through mode without binding the vector. Before capture it can reduce burden entering the column; after capture it can lower residual HCP and DNA.
Targeted HCP Clearance Data Demonstrates Pre-Affinity Capture Protection, Post-Affinity Impurity Reduction.
The following key conclusions were drawn from peer-reviewed studies conducted at ChromaGenix and NC State University.
Data supports targeted HCP clearance before affinity capture to reduce fouling and sustain resin performance, and after capture to lower residual HCP and DNA burden while preserving AAV recovery.
HCP reduction is measurable in viral vector process fluids
Studies using HEK293-derived viral vector process fluids show greater than 60% HCP reduction under evaluated conditions, supporting the case for a dedicated HCP clearance step designed around viral vector impurity burden.
Vector recovery is maintained in the evaluated workflow
Up to 95% of 5,200 HCP species across four CHO fluids are captured, confirming the mechanism is not limited to a single process or cell line.
HCP clearance is observed across multiple AAV serotypes
The synthetic peptide ensemble captures high-risk species upstream of affinity capture in a single pass without binding product — preserving mAb recovery in the flow-through fraction.
Capture consistency may improve when HCP burden is reduced
A meaningful upstream polishing intervention that reduces the impurity burden entering Protein A and protects long-term chromatography performance.
Protect Affinity Capture Resin
Reducing HCP, DNA and process-debris burden before capture may help limit fouling and support more consistent affinity-resin performance.
Preserve Vector Recovery
The flow-through design is intended to reduce impurity burden without making the viral vector the binding target.
Reduce Polishing Pressure
More selective impurity control may reduce the burden placed on later polishing steps and simplify the clearance strategy.
Improve Process Consistency
Better control of the feed entering or leaving affinity capture may improve recovery consistency and downstream reproducibility.
Moving Beyond Non-Selective Polishing: Reproducible, Proteomics-Informed HCP Clearance for Viral Vector Processes
Protect Affinity Capture Resin
Preserve Vector Recovery
Reduce Polishing Pressure
Improve Process Consistency
Why participate?
Early technical visibility
Review emerging technology direction before release.
Direct product input
Help define the performance thresholds, process conditions, analytical readouts and GMP-readiness expectations that would make a future product useful.
Scientist-led discussion
Engage with ChromaGenix technical teams on the process problem, not a generic sales pitch.
Potential evaluation pathway
Where there is technical fit, discussion may progress toward deeper data review, Product Focus Group participation, prototype evaluation or collaboration.
What you can expect
01
Scoping conversation
A brief discussion to confirm fit, context and the scientific value of collaboration.
02
Defined collaboration
A structured technical discussion with ChromaGenix process scientists, grounded in your process context to identify constraints and potential solutions.
03
Ongoing development
Continued engagement to support development, testing and refinement toward a better purification solution, shaped by what you have shared.
Evaluating AAV capture? Discover AvXcelTM
Our serotype-agnostic, alkaline-stable AAV affinity resin with flexible elution properties for higher recovery and preserved viral activity.
Moving Beyond Non-Selective Polishing: Reproducible, Proteomics-Informed HCP Clearance for Viral Vector Processes
Why wait for better purification tools when you can help shape them?
Join NAVIGATE as an early adopter. Test new resins with your own feedstock, access pre-commercial data, and be first to know when products launch.
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