Custom POROS Resins

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Addressing purification challenges beyond standard resins

During process development and early manufacturing, purification challenges often emerge after standard chromatography resins have been evaluated. Aggregate removal may be limited. Host cell protein (HCP) clearance may be insufficient despite optimization in buffer conditions. In some processes, pressure constraints can limit target residence times, which can impact productivity.

When standard chromatography resins no longer respond to further changes in operating conditions and material properties become the limiting factor, POROS chromatography resins should be evaluated. In these cases, bead architecture and flow behavior define whether the required separation performance can be achieved within the available operating window.

A structured approach to custom POROS resin development

Custom development often raises concerns around timelines, scope creep, and how many iterations it will take to reach a usable outcome. For POROS resins, development follows a defined, milestone-based path, with screening and decision points tied to process-relevant data. This structure helps maintain alignment with the customer’s purification objectives while allowing adjustments when the data warrants them.

Experimental design
Prototyping evaluation
Bead architecture
Bioprocess-ready resin

Process-driven experimental design

Reduce trial-and-error by grounding experimental design in molecule behavior and process intent. POROS resin development uses focused Design of Experiments (DoE) to test variables, such as pore size and ligand density, against defined performance targets.

Prototyping evaluation under process-relevant conditions

Evaluate prototype resins under the conditions that reflect how the process is executed. Residence time, load challenges, and representative feedstreams, including intermediate process pools or cell culture harvests, are used to assess performance. Testing is carried out in close collaboration to reflect practical operating limits under realistic conditions.

Bead architecture and surface chemistry options

Tune measurable outcomes by selecting bead structures and surface chemistries that directly influence dynamic binding capacity (DBC), impurity separation, and pressure–flow behavior.

Bioprocess-ready resin formats

Move to final formats after the resin design has been defined and aligned with performance expectations. Once development targets are met, the resin can be prepared as bulk material or packed into columns to support downstream process (DSP) development and implementation.

Designed to support scale-up and manufacturing readiness

Transitioning from development to manufacturing can expose gaps that were not apparent at a small scale, particularly around flow performance, robustness, and reproducibility. Thermo Fisher Scientific custom POROS resin development accounts for these constraints early, with design choices evaluated for how they translate across scale-up and defined operating ranges.

Consistency across development and manufacturing

Limit performance variability as processes move from development to manufacturing by maintaining consistent resin attributes and defined material specifications throughout. Custom POROS resin development emphasizes reproducibility, so performance observed during evaluation can be carried forward more consistently into manufacturing.

Stability studies and cGMP documentation support

Support lifecycle and regulatory expectations by supporting stability studies and documentation aligned with cGMP manufacturing requirements, helping maintain continuity. Process verification and regulatory requirements are supported by an ISO 9001/13485 quality management system.

Discover custom chromatography resin development

Explore additional chromatography resin development services designed to address purification challenges that extend beyond a single interaction mode. Custom chromatography resins are developed using the same structured, data-driven approach, with resin and ligand properties, such as selectivity, capacity, and operating behavior, based on how the molecule performs within the broader purification workflow.

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Discuss your process requirements

Every purification workflow reflects a specific molecule, feedstream, and set of development constraints. A technical discussion can help clarify whether custom POROS resin development is appropriate, and what level of definition is needed to proceed.

Poster: Enabling custom solutions for downstream processing

Publication: Camelid VHH affinity ligands enable separation of closely related biopharmaceuticals

Webinar: Solving purification bottlenecks in biotherapeutics with custom resin solutions

Whitepaper: Custom chromatography solutions for complex biotherapeutics

Frequently asked questions

A custom POROS resin is typically considered when continued optimization or screening of standard chromatography resins no longer produces meaningful improvements. This often occurs when limits in selectivity, aggregate removal, impurity clearance, or flow performance persist despite process adjustments. At that point, further operating changes tend to confirm the same limitations.

Development can begin before the process is fully defined. Early work often starts with what is already known about the molecule and feedstream, even if operating ranges or step sequencing are still changing. As prototype data is generated, those assumptions are tested and refined, allowing process definition to progress alongside resin development.

Development risk is managed by intentionally limiting scope at each stage. Screening focuses on a small, defined set of variables directly tied to the observed process constraint, with clear decision points before advancing. Data from each phase is reviewed before expanding scope, so designs that do not shift performance positively are stopped early.

Performance is evaluated using prototype resins tested under conditions that reflect the intended process. This includes defined residence times, load challenges, and the use of representative feedstreams. Data is reviewed against the original performance constraint, such as resolution, impurity clearance, or flow behavior, before a decision is made to advance toward larger-scale implementation.

Scale-up is considered while the resin is still being designed, not after performance has been demonstrated at a small scale. Bead structure, surface chemistry, and pressure–flow behavior are evaluated with an eye toward how they translate across column diameters and operating ranges. This helps reduce changes later when adjustments become harder to accommodate during manufacturing.

Chromatography resources

Access additional chromatography resources for deeper technical support. These materials focus on purification fundamentals, resin behavior, and workflow considerations that can support decision-making during process development and optimization.

Explore resources