NAVIGATE x HCP Clearance | rProteins
HCP Species mapped across
CHO feeds
Captured by ChromaGenix
resin
HCP LOG REDUCTION
Solving the Persistent HCP Challenge in rProtein Purification
The full figure set, development data and process rationale, drawn from peer-reviewed work across four independent CHO feeds. Complete the short form to download the PDF.
- Core-shell purification mechanism: How the ~400–700 kDa size-exclusion shell excludes IgG while the peptide ensemble captures smaller HCPs in flow-through.
- 5,200-species proteomics map: HCP capture fraction across loading volumes for four CHO feeds, at identity-level resolution.
- Named high-risk HCPs cleared: Cathepsins, Clusterin, ER Chaperone BiP, Lipoprotein Lipase, HTRA2 and Histone clusters .
- Three-step platform data: Stepwise HCP, hcDNA and aggregate profiles for bsAb1, bsAb2 and an Fc-fusion protein.
- Yield–purity contour mapsGlobal HCP LRV and mAb yield / purity by SEC as a function of column volumes loaded
Professor Stefano Menegatti
NORTH CAROLINA STATE UNIVERSITY | CHROMAGENIX
Why this session exists
As recombinant protein titers continue to rise, HCP burden is escalating in complexity and composition. Traditional CEX and AEX polishing steps are increasingly challenged to deliver consistent clearance without compromising yield. This is a problem the industry has not yet resolved at scale.
The ChromaGenix approach
ChromaGenix is developing selective ligand chemistries engineered to address exactly these HCP clearance challenges, combining targeted binding specificity with high-capacity polishing formats designed for commercial-scale manufacturing. A core-shell resin positions a synthetic peptide ensemble upstream of capture to intercept the highest-risk co-purifying species before they reach the affinity step.
Data Demonstrates HCPs That Evade Standard Polishing Can Be Cleared Before They Reach Affinity Capture
The following key conclusions were drawn from peer-reviewed studies conducted at ChromaGenix and NC State University across four independent CHO
harvest cell culture fluids, map HCP depletion at identity-level resolution and confirm that the selectivity mechanism is not feed-specific.
HCP co-purification is species-specific, not random
Synthetic peptide ligands can be developed around the molecular features of a target or impurity. This supports more selective capture or impurity removal where broad binding alone is not enough.
Selectivity is consistent across independent feeds
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.
Flow-through removal pre-Protein A is effective
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.
Clearance exceeds 3.5 logs in the pre-affinity step
A meaningful upstream polishing intervention that reduces the impurity burden entering Protein A and protects long-term chromatography performance.
Solving the Persistent HCP Challenge in rProtein Purification
Target the HCPs That Matter
Preserve Valuable Product
Specificity Beyond IEX Polishing
Platform-Ready Robustness
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.
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.
Complete the form and a member of our team will be in touch shortly.