Clarification
Controls flow, pressure, turbidity, and filter utilization.
Downstream purification
Protect yield from harvest to bulk drug substance.
Bioseon controls clarification, Protein A and ion-exchange chromatography, UF/DF, viral inactivation, and filtration so expensive resin, single-use consumables, and product mass are used with precision.
Capture → bulk DS
Purification control for biologics.
Designed to hand a high-quality bulk drug substance to sterile fill-finish with fewer deviations and less yield loss.
The purification challenge.
Downstream teams must recover product, remove impurities, protect CQAs, and preserve facility capacity. Protein A resin and single-use consumables are expensive, volatile inputs, while late deviations can erase upstream gains.
- Harvest variability changes load and clarification behavior
- Chromatography decisions affect yield, purity, and resin utilization
- UF/DF and viral steps must protect concentration, buffer exchange, and safety
Control every skid as one train
Bioseon links harvest, capture, polish, UF/DF, viral inactivation, and filtration decisions to the same live batch objective.
Clarification and harvest.
The harvest-and-purify agent uses upstream state, turbidity, flow, pressure, and filter performance to coordinate harvest timing, clarification settings, and handoff into capture.
- Harvest timing tied to culture and titer state
- Clarification loads controlled against fouling risk
- Material and equipment context preserved for the batch record
Harvest
Links upstream endpoint and downstream readiness before product leaves the bioreactor.
Chromatography control.
Bioseon coordinates Protein A capture and ion-exchange polishing around load, wash, elution profile, conductivity, pH, pooling, impurity clearance, and resin life.
Protein A capture
Protects resin capacity, loading strategy, wash behavior, elution, and pool quality.
Ion-exchange polish
Controls conductivity ramp, pH, flow, and pooling against purity and CQA goals.
Pool decisions
Balances recovery, impurity clearance, and downstream load constraints.
Resin economics
Tracks resin utilization and cycle context when supply and cost are volatile.
UF/DF concentration and buffer exchange.
Ultrafiltration and diafiltration decide concentration, buffer exchange, product recovery, and final bulk conditions. Bioseon watches pressure, flux, conductivity, volume, and product trajectory to reduce avoidable loss.
- Flux and pressure managed against fouling
- Diafiltration progress linked to conductivity and buffer exchange targets
- Concentration endpoint aligned to bulk drug substance requirements
UF/DF state
One controlled view of transmembrane pressure, flow, volume, conductivity, concentration, and hold conditions.
Viral inactivation and filtration.
Bioseon keeps viral safety steps tied to recipe phase, pH, hold time, filter performance, and batch-record evidence.
Viral inactivation
Tracks pH, time, temperature, and hold criteria.
Viral filtration
Watches pressure, flow, throughput, and filter risk.
Bioburden context
Links environmental and process signals to deviation workflows.
Record evidence
Captures execution, exceptions, and approvals for GMP review.
Yield and resin economics matter at every step.
YIELD
Protected. Pooling, load, flow, and endpoint decisions preserve product mass.
PROTEIN A
Optimized. Resin utilization is tracked against capacity, cycles, and batch value.
SINGLE-USE
Controlled. Consumables are managed against live process need and supply volatility.
DEVIATIONS
Reduced. Each action is constrained, traceable, and ready for review by exception.
Capture-to-bulk sequence.
- 01
Harvest
Receive culture endpoint and product state from upstream.
- 02
Capture
Load Protein A or capture step against capacity, purity, and recovery targets.
- 03
Polish
Use ion-exchange and related steps to clear impurities and protect CQAs.
- 04
UF/DF
Concentrate product and exchange buffer into target bulk conditions.
- 05
Viral
Execute inactivation and filtration with complete process evidence.
- 06
Bulk DS
Hand bulk drug substance to sterile fill-finish with traceable batch context.
Manual control versus Bioseon control.
| Decision | Manual operation | Bioseon control |
|---|---|---|
| Capture loading | Based on recipe, operator judgment, and delayed analytics | Adjusted to live harvest state, capacity, resin context, and yield target |
| Pooling | Often conservative to avoid impurity risk | Balanced against purity, recovery, CQA, and downstream constraints |
| UF/DF endpoint | Managed by pressure, conductivity, volume, and manual review | Coordinated across flux, concentration, buffer exchange, and bulk DS target |
| Records | Reviewed after execution with exception discovery late | Built continuously with Part 11 audit trail and review by exception |
Related capabilities.
Upstream control
Start purification with the right culture endpoint and titer state.
Explore upstreamTiter and CQA sensing
Connect process signals to titer, quality, impurity, and release readiness.
Explore sensingDigital twin
Simulate capture, polish, UF/DF, and facility constraints before acting.
Explore twinPricing for purification skids.
The Line tier is $13,000 per bioreactor or skid per month. Site is $85,000 per month. Enterprise programs are custom with land from $700k–$8M ACV.
Best first skid
Start with a capture or UF/DF skid where resin, consumables, yield, or review burden creates a clear value case.
Downstream questions.
Which downstream steps are supported?
Bioseon supports clarification and harvest, Protein A capture, ion-exchange chromatography, UF/DF, viral inactivation, viral filtration, and bulk drug substance handoff.
How does Bioseon help with Protein A resin?
It tracks resin capacity, cycle context, loading, wash, elution, and pooling decisions so expensive resin is used against live process value.
Does it support single-use purification?
Yes. Bioseon is built for single-use skids and consumables, including volatile material availability and process-specific utilization.
How does downstream connect to upstream?
The harvest-and-purify agent receives upstream titer, VCD, culture endpoint, and risk context so purification starts from the real batch state.
Control purification with the same precision as culture.
Request access and scope Bioseon on a capture, polish, UF/DF, or full downstream train.