Outsource your Purification

Included when the best chromatographic mode, resin, or buffer system is unknown — for example, when analytical resolution is poor or the molecule has not been separated preparatively before.

Typical scope:

• Evaluation of multiple preparative resins (e.g. 3+ resins) across 2–3 buffer systems
• Assessment of pH, conductivity, and temperature effects on resolution
• Initial loading studies without fractionation
• Fractionation of best conditions; samples provided for your analysis

You receive:

• Screening report with recommended resin/buffer combination
• Feasibility assessment — can the target variants be resolved preparatively?
• Fractionated samples for your independent confirmation

Starting material required: Defined per project — typically a small quantity (e.g. ≥ 500 mg) depending on the number of conditions to screen

Decision Point: You review the screening data and decide whether to proceed to method development.

The core of every project. This phase produces an optimised preparative method and defines the fractions to be collected in production.

Typical scope:

• Reproduction or optimisation of your existing analytical/preparative method, or development of a new method from scratch
• Systematic loading studies with the preferred resin/buffer system
• Gradient optimisation for maximum resolution
• Fractionation of runs with analytical HPLC (or SEC, SCX, etc.) analysis of all fractions
• Definition of target peak fractions and collection windows for production
• Where required: development or optimisation of an analytical HPLC method for purity and identity assessment
• Estimation of achievable quantities and purities in the production phase
• Provision of fractions for your independent verification (e.g. isoelectric focusing, CE, analytical SCX/SEC)

You receive:

• Optimised preparative chromatography method
• Analytical data for all collected fractions
• Quantity and purity estimates for production
• Detailed report (PowerPoint) with method parameters and chromatograms
• Fractions for your own characterisation

Starting material required: Defined per project — can range from as little as 10 mg (for small-scale feasibility) to several grams, depending on the number of fractions and starting materials

Decision Point: You and YMC ChromaCon jointly review the data. This review confirms which fractions to produce, the expected yields and purities, and the amount of starting material needed for production.

Execution of the validated method to produce the agreed quantities of each target fraction, followed by concentration, formulation, and delivery.

Typical scope:

• Preparative chromatography runs to produce each target fraction in the agreed quantities
• Concentration to target volume and protein concentration
• Analytical HPLC (or equivalent) quality check on every production lot
• Formulation into your specified buffer (or DI water, filtered 0.22 µm, if preferred)
• Shipment under controlled temperature conditions

You receive:

• Purified variant or isoform fractions at agreed purity (typically > 90%) and concentration
• Analytical chromatograms and certificates for each fraction
• Final project report with complete documentation
• Formulated material shipped to your facility

Starting material required: Defined during feasibility — depends on the number of fractions, target quantities, and isoform abundance in the feed. Can range from tens of milligrams to tens of grams per starting material.

• Number and identity of fractions to be isolated (e.g. peaks 1–6, acidic/main/basic, HMW/main/LMW)
• Target quantity per fraction (e.g. > 2 mg, > 10 mg)
• Desired purity per fraction (typically > 90%)
• Required final concentration and volume
• Number of different starting materials to be processed (e.g. 1 mAb, 3 mAbs, stressed and unstressed)

• Analytical chromatogram or electropherogram of each starting material, with target peaks identified
• Estimated percentage of each target fraction in the starting material
• Concentration of starting material (minimum ≥ 0.5 mg/mL recommended)
• Total amount of starting material available for feasibility and production
• Any known stability constraints (pH, temperature, storage)

• Analytical method and column you use to assess product quality (e.g. SCX, SEC, WAX, iCE, CE-SDS)
• If you have an existing preparative or analytical method you’d like us to reproduce or optimise, provide the method details (column, dimensions, buffers, gradient, flow rate, load)
• Formulation buffer composition (or specify DI water + 0.22 µm filtration)
• Sterile filling requirements, if applicable

If you’re unsure about any of these, get in touch — we’re happy to discuss your project informally before a formal quote.

We perform charge variant fractionation (via SCX, WAX, or SAX ion exchange), size variant fractionation (via SEC), reversed-phase separations for peptides, and other modes as needed. The chromatographic approach is selected — or screened — based on your molecule and your target fractions.

For most monoclonal antibody isoforms and size variants, we target > 90% purity as measured by analytical HPLC or SEC. Achievable purity depends on the resolution between your target fractions — we assess this during the feasibility phase and provide a realistic estimate before you commit to production.

Yes. We have experience with monoclonal antibodies, bispecific constructs, Fc-fusion proteins, and peptide hormones. Contact us to discuss your specific molecule.

This is exactly what the feasibility phase is designed to assess. If the data shows that preparative separation is not achievable at the required purity, you have a clear exit point with no obligation to proceed. You receive a full report on what was tested and what was learned.

No, we do not offer GLP or GMP level services.

This varies widely. Feasibility studies can work with as little as 10–12 mg of protein. Production quantities depend on the number of fractions, the abundance of each target in the feed, and the amount you need — ranging from tens of milligrams to tens of grams. We define the exact requirement at the end of the feasibility phase.

Yes — this is common. Many projects involve 3 or more different starting materials (e.g. multiple mAb batches, or both stressed and unstressed samples) processed using the same preparative method.

Yes. If you don’t have a suitable analytical method for assessing fraction purity, or if your existing method needs optimization, we can include analytical method development in the project scope.

Not necessarily. If you have an existing analytical or preparative method, we can reproduce or optimise it. If not, we develop a method from scratch during the feasibility phase. Let us know what you have available when requesting a quote.

Formulation into your specified buffer is included in the production phase. Sterile filling can be discussed as part of your project scope — include this requirement in your quote request.

A two-phase project (feasibility + production) typically runs 8–12 weeks. A three-phase project including initial screening runs 14–20 weeks. Timelines depend on the complexity of the separation and the number of starting materials.

YMC ChromaCon’s in-house custom purification service is available to customers across Europe. Customers in other regions should contact their local distributor, who may offer purification services under separate agreements.

Yes. You may stop after any project phase. You are only obligated to pay for completed work and any work in progress (prorated to effort expended).