Summary
- The problem
- Chromatography exports, fraction assays, filtration studies and buffer records sit in separate files. A pooling decision is made on step recovery alone, and the reasoning behind the chosen train is hard to recover when the process moves to another site.
- Seal’s approach
- Protocols, runs, fractions, pools, samples and results share one record with the purification train, column and membrane history and the calculation basis at each step. Neil compares runs and prepares the next study; scientists review the interpretation.
- What changes
- A higher-recovery pool is not mistaken for a better one: pooled quality stays “not measured” until it has been tested, and the chosen process carries its limits, assumptions and development evidence into transfer.
- Where to start
- One purification study: its method, fraction results and the decision in front of the team. Book a demo.
Run the purification protocol in Seal.
Why teams choose Seal for downstream development
Purification development usually leaves fractions in the chromatography software, assays in a LIMS or spreadsheet and pooling decisions in a notebook. Seal configures load preparation, collection, pooling and filtration as records that keep quantities, calculations and sample identity with the execution, while ÄKTA and other instruments retain their acquisition data. A pooling decision can be reviewed against its fraction assays, and the purification train carries its evidence into scale-up.
Chromatography study
- Identify the load, resin and method
- Record fractions and link their assays
- Assess the pool before recording pooling
DSP-019
- Protein loaded
- 2,000 mg
- Fractions collected
- F01–F08
- Pooling decision
- Not recorded
Pool assessment pending
Configure with Neil. Test with your team. Reuse the protocol.
Each run keeps its own values, evidence and history.
Decide the pool from the fractions and their assays.
Pooling is where recovery and quality pull against each other, and it is often decided from step recovery alone because the fraction assays sit in another file. In Seal each collected fraction stays linked to its protein and HCP results and to the method versions that produced them.
In run CHR-014, widening the pool from F03–F06 to F02–F07 raises recovery from 70% to 82% of the 2,000 mg loaded, but adds fractions with HCP of 70 and 95 ng/mg against 9 to 22 in the core. The wider pool’s quality stays “not measured” until a candidate pool has been tested.
CHR-014 / elution
82% recovered
1,640 mg in 120 mL
The wider pool adds 240 mg. It also brings in F02 and F07, which have higher host-cell protein results.
Test the candidate pool before choosing.
Develop the whole purification train.
The same record carries through filtration, holds and transfer, so each step keeps its material genealogy and calculation basis as studies, methods and scale change. Start with one decision and extend from there.
Chromatography
Compare load, method version, column history and fraction results. Keep a pooling decision connected to the run that produced it.
What stays connected
Retain resin lot, column geometry, packing and cycle history, buffers, actual flow and pressure, collection events and sample methods. A proposed change to a collection rule remains a draft until the team reviews and tests it.
Filtration and concentration
Follow the material through membranes, concentration and buffer exchange. Compare recovery using the same calculation basis.
What stays connected
Connect membrane identity and area, feed and retentate quantities, permeate, process conditions, sample withdrawals and hold-up estimates. Keep measured losses separate from assumptions; do not equate a single step’s recovery with overall process yield.
Intermediate pools and holds
Know what entered each pool, where it went and which results support its next use.
What stays connected
Carry parent fractions, actual quantities, containers, transfers, storage and hold intervals into the pool record. Record sampling losses and the measured pool composition. Quality and downstream suitability require their own assessment.
Scale-up and transfer
Carry the chosen process forward with its limits, assumptions and development evidence.
What stays connected
Ask Neil to compare receiving equipment, loading, residence time, flow, pressure and hold assumptions. Prepare a transfer work plan with the evidence needed to resolve differences. A matching setting does not prove scale equivalence.
Use the records your team already has.
Start with ÄKTA / UNICORN exports, your lab results and study records. Agree the files or permitted connection; keep the original run and method with the analysis.
Explore connectionsAQuestions and answers
Can we configure and execute protocols in Seal?
Yes. Configure reusable protocols with instructions, fields, calculations, linked samples and review steps. Each execution retains the version used, recorded values, observations and results. Neil can help prepare the configuration and analyse the resulting evidence; your team tests the workflow and defines the review and approval requirements for its intended use.
What does this pooling example calculate?
It sums recorded protein mass and volume for the selected fractions. Recovery is selected protein mass divided by the 2,000 mg loaded to this step. Core F03–F06 contains 1,400 mg in 80 mL (70%); wider F02–F07 contains 1,640 mg in 120 mL (82%). These are fictional development records, not live instrument results.
Does the higher-recovery option have acceptable quality?
That is not established. The added fractions have HCP results of 70 and 95 ng/mg protein; core fractions range from 9 to 22. No acceptance criterion is supplied, and the example does not calculate or approve pooled quality. Prepare and test a candidate pool against the study’s requirements before making the pooling decision.
How do the trace and fraction assays relate?
The run view is a synthetic UV trace illustrating eight 20 mL collection intervals, not an actual ÄKTA capture. Switch to fraction assays to see the fictional protein masses used for recovery. The calculation does not infer protein mass or impurity clearance from UV peak area. Actual chromatograms, method versions and instrument events can be linked to fraction records in a configured workflow.
Can we start with existing chromatography and lab systems?
Yes. Agree which method versions, instrument files, fractions, sample results and material records to connect or supply. Access depends on the source software, export or API and configured permissions. This page does not demonstrate a live instrument query or send commands to a chromatography system.
What about the rest of downstream development?
Connect capture and polishing studies with filtration, concentration, buffer exchange, intermediate holds and transfer work. Retain the material genealogy and calculation basis at each step. Scale-up, quality, clearance and process suitability need their own evidence rather than being inferred from recovery.
What can Neil prepare for the team?
Ask for a run comparison, pooling assessment, mass-balance reconciliation, proposed study or transfer work plan. The output should retain source versions, calculations, missing evidence and open decisions. Your scientists review the interpretation and decide which process to take forward.