Scale Magnetic Bead Separation
from Development to GMP
A magnetic bead protocol that works in a small tube may behave differently when working volume, vessel geometry, bead travel distance and process handling change.
Sepmag provides a structured scale-up path based on constant magnetic force, real-time monitoring and systems designed for process development through manufacturing.
Reduce scale-up rework, transfer defined process conditions and verify separation performance at every stage.
Reduce Risk from Development to Manufacturing
Less Scale-Up Rework
Develop the process using a separation principle that can continue into pilot and manufacturing environments.
More Defined Technology Transfer
Transfer documented magnetic conditions, operating parameters and endpoint criteria—not only a waiting time.
Objective Performance Verification
Measure separation behaviour at each scale and compare it with an established reference.
More Consistent Manufacturing
Reduce variability caused by localized magnetic-force conditions and subjective endpoint decisions.
Better Validation Support
Generate quantitative, traceable process data for characterization, qualification, validation and continued process verification.
Why Magnetic Separation Changes at Scale
Scale-up is not simply a matter of using a larger vessel and a stronger magnet.
As working volume increases:
Vessel geometry and bead travel distance change
Mixing and bead resuspension become more critical
Sample viscosity and bead concentration may affect separation kinetics
Localized magnetic systems can create increasingly different force conditions across the vessel
Visual observation becomes less reliable as an endpoint criterion
A transferable process therefore requires both defined magnetic conditions and objective measurement of separation performance.
Develop. Characterize. Transfer. Verify.
Develop the Process
Define the bead type, concentration, buffer conditions, vessel, working volume, mixing method, magnetic conditions and required endpoint. Sepmag process-development systems allow these conditions to be evaluated before committing to a manufacturing configuration.
Characterize Separation Behaviour
Use MONITOR to record the separation curve and quantify how the process develops over time. Evaluate reproducibility, compare operating conditions and determine which parameters should be controlled during scale-up.
Transfer to the Manufacturing Scale
Move to a larger Sepmag system based on the same constant-force separation principle. The magnetic force remains defined throughout the working volume, while separation time and other operating parameters can be established for the new vessel and scale.
Verify Routine Performance
Use QUALITANCE to compare manufacturing runs with an approved reference profile, identify deviations and maintain traceable separation records. This turns technology transfer into a measurable process rather than a visual comparison between small- and large-scale results.
A Scalable Technology Platform
Constant Magnetic Force at Every Stage
Each Sepmag system applies a constant, defined magnetic force throughout its working volume.
This gives beads controlled separation conditions regardless of their starting position and reduces the variability associated with localized strong- and weak-force zones.
Monitoring from Development to Manufacturing
MONITOR supports process development, protocol comparison and separation characterization.
QUALITANCE supports routine manufacturing by comparing actual separation behaviour with defined reference profiles and documenting process performance.
A Clear Path from Process Development to Production
Process Development and Pilot Scale
Sepmag A with MONITOR
Develop, characterize and standardize the magnetic separation step before manufacturing transfer.
Manufacturing with Glass Vessels
Sepmag Q with QUALITANCE
Transfer the process into large-volume glass-vessel manufacturing environments.
Manufacturing with Plastic or Single-Use Vessels
Sepmag N with QUALITANCE
Support production workflows using plastic, disposable or single-use vessel formats.
What GMP Readiness Means
GMP readiness is more than installing a larger magnetic separator. It means that the magnetic separation step can be:
Defined through controlled operating parameters
Characterized using quantitative process data
Verified against objective acceptance criteria
Documented with traceable electronic records
Investigated when process deviations occur
Integrated into automated or semi-automated workflows
Supported during qualification and validation activities
QUALITANCE operates within Sepmag’s 21 CFR Part 11-ready software environment, supporting electronic records, controlled access, audit trails and secure data management.
These capabilities support the customer’s validated manufacturing process and quality system. They do not replace the customer’s own qualification, validation and GMP responsibilities.
Plan Scale-Up Before It Becomes a Bottleneck
Tell us your current and target volumes, bead type, vessel format, process conditions and manufacturing requirements.
Sepmag will help you define a development-to-manufacturing strategy for controlled, measurable and scalable magnetic bead separation.
