Dynamic Process Control

Closed-Loop UV Control. AutoPeak® & AutomAb®.

Real-time UV control that compensates for feed variation, column aging, and gradient drift — keeping every cycle on target without operator intervention. │ 24/7 Unattended GMP operation │ Validated as Process Analytical Technology │ Built into ChromIQ®

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AutomAb® – Application Note

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AutomAb® – Application Note

The Problem with Timed Processes

Continuous chromatography is cyclic — the same columns are loaded, washed, and eluted dozens, hundreds, or thousands of times over a campaign. In a purely timed process, every phase switch happens at a fixed time point set during method development. That works only when nothing changes.

But things change. Feed titers fluctuate batch-to-batch. Columns age. Buffer batches vary. Temperature shifts affecting retention time. Any of these moves either the breakthrough curve (capture steps) or the elution peak (polishing steps) relative to your fixed timing. In a timed process, that translates directly to yield loss, purity excursions, or both.

Managing this manually — an operator adjusting windows by hand each cycle — is not 24/7 manufacturing. It is supervised batch operation running faster.

From Development to Manufacturing: Where Dynamic Control Fits

Fixed-time operation is the right starting point when converting a batch method to continuous mode. Conditions are well-defined, run numbers are low, and the process is closely supervised. AutoPeak® and AutomAb® are not required at this stage — and deliberately so: running without dynamic control first gives you a clean baseline and confirms the underlying process is sound.

For scale-up and sustained manufacturing operation, UV-based dynamic control becomes essential. Retention time drift, column aging, and feed titer variability accumulate over time and across scales in ways that fixed timing cannot accommodate. AutoPeak® and AutomAb® are the step that takes a process from development-ready to production-ready — closed-loop UV control systems embedded in ChromIQ®, activated in dedicated tabs within the standard process wizard, responding to what is actually happening at the column outlet in real time, every cycle, without further operator input.

AutoPeak® and AutomAb® — Side by Side

Both controllers share the same principle: a real-time UV signal at the column outlet triggers the process decision, not the clock.

	AutoPeak®	AutomAb®
Applied to	MCSGP, N-Rich®	CaptureSMB®
Phase controlled	Elution — fraction collection	Loading — interconnected phase switch
Signal monitored	UV elution profile at column outlet	UV breakthrough signal at inter-column sensor
What it adjusts	Collection window boundaries for product cut and side-cut zones	Loading duration and phase switch timing between columns
Compensates for	Retention time drift, column aging, bed-height variation, feed variability	Feed titer variability, column aging, bed-height variation
Configured in	MCSGP Wizard — “AutoPeak® Process Control” tab / N-Rich® Wizard — “AutoPeak®” tab	CaptureSMB® Wizard — “Method Settings & Performance” tab
Scales to	CUBE → PILOT 300X → TWIN HPLC	CUBE → TWIN LPLC – Capture

How AutoPeak® Works

Four phase transitions, independently controlled

AutoPeak® controls up to four boundaries in the MCSGP elution profile — weak recycling start (t2), product collection start (t3), product collection end (t4), and strong recycling end (t5). Each maps to a section boundary defined on the batch chromatogram in the wizard. Each can be activated independently: activate only the transitions where drift is a real risk for your separation.

Two trigger types, one peak

Peak-front transitions (t2, t3 on ascending slope) use an absolute UV threshold in mAU — A new process phase is started the moment the rising signal passes the set level. Peak-tail transitions (t3/t4/t5 on descending slope) use a relative threshold — a percentage of that switch’s peak maximum — recalculated fresh every switch. This means tail triggers adapt automatically to changes in peak height as well as peak position.

Self-updating across the full column lifetime

The combined effect: fraction boundaries follow the peak wherever it moves — retention time drift, peak height changes, resin aging — without any operator input after initial setup. One practical prerequisite: AutoPeak® performs best when the UV peak maximum falls between 100 and 1000 mAU, within the detector’s linear range. Outside this window, a simple path length or sensitivity adjustment gives cleaner control.

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How AutomAb® Works

AutomAb® solves the titer variability problem for CaptureSMB® not by watching for a UV level to be crossed, but by integrating the UV signal over the entire interconnected loading phase. The detector between the two columns monitors the UV continuously as product begins to break through the upstream column. AutomAb® subtracts the impurity baseline — measured automatically in the previous switch — and integrates the remaining signal over time. This running integral is the “preload area”, which is proportional to the mass of target compound entering the downstream column.

Interconnected loading continues until the accumulated preload area reaches the target preload area setpoint. If the titer is higher in this cycle, breakthrough emerges faster, the target preload area is reached sooner, the loading is stopped earlier. If the titer is lower, loading is stopped later. The result is always the same amount of product loaded onto the downstream column — consistent cycle after cycle, independent of feed variability or resin age.

This requires only the single UV sensor positioned between the two columns.

Verifying Control Performance: The Evaluation Center

The Evaluation Center makes dynamic control performance visible and documentable.

Cycle Overlay — Overlay multiple cycles in one view. Verify cycle to cycle process consistency with visual confirmation of AutoPeak® or AutomAb® control performance at a glance
Auto Integration — Process stability of MCSGP is usually evident when the Area Under Curve for the product fraction is consistent from cycle to cycle. With AutoPeak® active, integration results remain stable even when the elution peak shifts. With CaptureSMB®, cycle to cycle product peak integration also provides an indication of process stability.
PDF and Excel export — Every cycle’s UV data, trigger events, and integration results compiled into a structured report for process records or regulatory submissions

The ChromIQ® logbook records every AutoPeak® UV trigger event and every AutomAb® phase switch with timestamp and the triggering value — for AutoPeak® this is the UV level (absolute or relative) that started a new phase; for AutomAb® it is the accumulated preload area value at the point the switch was triggered. An unalterable record of every autonomous decision the system made.

Applications

AutoPeak® and AutomAb® are relevant wherever process drift, titer variability, or column aging would otherwise require manual intervention or conservative operating margins.

Molecule class	Controller	Example Application
Monoclonal antibodies (mAbs)	AutomAb®	Protein A capture — CaptureSMB® loading control for batch-to-batch titer variation
Monoclonal antibodies (mAbs)	AutoPeak®	Charge variant separation via CIEX MCSGP — collection window tracking over extended campaigns
Bispecifics / antibody variants	AutoPeak®	Complex charge variant profiles — tight windows requiring precise UV-triggered boundaries
Peptides	AutoPeak®	RP MCSGP polishing — compensation for gradient retention time drift across long synthesis batches
Oligonucleotides	AutoPeak®	AEX MCSGP polishing — close-eluting species where collection window precision is critical
Recombinant proteins	AutomAb® + AutoPeak®	Affinity capture (AutomAb®) followed by IEX MCSGP polishing (AutoPeak®)
Impurity isolation (N-Rich)	AutoPeak®	Final elution fractionation of accumulated target — boundaries track actual elution signals
AAV / gene therapy	AutoPeak®	IEX polishing with high-value capsid fractions — automated boundaries minimise losses

All Contichrom® Systems are Enabled with Dynamic Process Control Control

AutoPeak® & AutomAb® Control are Standard Features with Systems running CaptureSMB®, MCSGP & N-Rich®

Systems Overview

Contichrom® CUBE

The essential platform for chromatography process development. This versatile 100-bar benchtop FPLC system runs batch, integrated batch, and continuous chromatography — including MCSGP and CaptureSMB — out of the box. Develop purification processes for mAbs, peptides, oligonucleotides, ADCs, and viral vectors, with verified scale-up at over 100× to pilot and production systems.

Contichrom® PILOT

Scale peptide and oligonucleotide purification to pilot and clinical GMP manufacturing. This 100-bar preparative HPLC system features MCSGP with AutoPeak® to eliminate the yield-purity trade-off — delivering +10–50% absolute yield increase at target purity and significantly less solvent than batch HPLC. ATEX Zone 2 / Class I Div 2 certified for organic solvents. Flow rates up to 300 mL/min.

Contichrom® TWIN HPLC

Produce peptides and oligonucleotides at commercial GMP scale. This 80-bar industrial HPLC system uses MCSGP with AutoPeak® to eliminate the yield-purity trade-off — increasing recovery to >90% while reducing solvent consumption compared to batch. ATEX Zone 2 / Class I Div 2 certified for organic solvents, and flow rates up to 36 L/min.

Contichrom® TWIN LPLC – Capture

Accelerate biopharmaceutical capture chromatography at production scale. This sanitary GMP system uses CaptureSMB® with AutomAb® to maximize resin utilization — achieving up to 3× faster processing and 50% less Protein A resin and buffer consumption compared to batch. CIP-ready design for mAbs, viral vectors, ADCs, and recombinant proteins.

Contichrom® TWIN LPLC – Polishing

Bring continuous polishing to biopharmaceutical manufacturing at production scale. This sanitary GMP system uses MCSGP with AutoPeak® to eliminate the yield-purity trade-off achieving +10–50% absolute yield increase at target purity while reducing buffer consumption compared to batch. CIP-ready design for mAbs, viral vectors, ADCs, and recombinant proteins.

Systems Overview

One Setting. Continuous Adaptation. Consistent Results.

Book a CUBE Rental Schedule a Feasibility Study

Are AutoPeak® or AutomAb® separate software modules that requires an additional license?

No. Both are built into ChromIQ® and accessed through dedicated tabs within the standard process wizard — the “AutoPeak Process Control” tab in the MCSGP Wizard, the “AutoPeak” tab in the N-Rich Wizard, and the “Method Settings & Performance” tab in the CaptureSMB® Wizard for AutomAb®. No additional licence is required on the Contichrom® CUBE.

What happens if the UV signal goes outside the expected range mid-run?

ChromIQ® supports configurable out-of-range alarms. If a UV trigger is not reached within the detection window, the system enters freeze mode and pauses for operator review — the process never proceeds blindly past a missed trigger. All alarm and trigger events are recorded in the unalterable logbook with timestamps and triggering values.

Does dynamic control transfer to the PILOT 300X and TWIN production systems?

Yes. AutoPeak® is available in ChromIQ® X on the Contichrom® PILOT 300X with full 21 CFR Part 11 support. AutoPeak® and AutomAb® are available on the TWIN HPLC and TWIN LPLC systems respectively. The UV trigger values and preload area setpoints transfer directly with the method from CUBE development — no re-optimization required at scale.

Can I run continuous processes without activating dynamic control?

Yes, during process development. Fixed-time operation is the normal starting point when converting a batch method to continuous mode — conditions are well-defined, run numbers are low, and the process is closely supervised. AutoPeak® and AutomAb® are not needed at this stage. For robust scale-up and long-term manufacturing operation, however, UV-based dynamic control becomes essential. Retention time drift, column aging, and feed titer variability accumulate over time and across scales in ways that fixed timing cannot accommodate. Activating dynamic control is the step that takes a process from development-ready to production-ready.