Process Development
Separation and purification process development for pharmaceutical and fine chemical customers: process optimization, media and column screening, condition exploration and scale-up validation. With an in-house media library, a DAC equipment line (50–300 mm) and a complete analytical platform, we help customers settle on the best purification route in the shortest time.
From reactors and analytical platforms to the DAC preparative line, and on to SEM, elemental analysis and laser particle sizing for characterizing the beads themselves — essentially all the hardware process development needs is in our own hands.
Drawing on years of chromatographic purification experience, our technical team develops separation and purification processes from bench to pilot scale: target molecule property assessment → media and column screening → mobile phase and gradient optimization → balancing yield against purity → scale-up feasibility validation. A complete process package and method validation report are delivered, shortening the customer's development cycle and reducing the cost of trial and error with media.
Four foundations: our own media, our own equipment, our own analysis, our own team
The real bottleneck in process development is usually not "we cannot think of a method" but "we cannot get the medium, cannot get instrument time, cannot wait for the analysis". All three are in our own hands, so screening does not wait on lead times and scale-up does not depend on borrowed capacity.
An Extensive In-House Media Library
Screening draws directly on stock, with no external purchasing and no time taken out of the customer's schedule, which fundamentally reduces the cost of trial and error with media.
- Daisogel silica(master distributor) — the full reversed-phase C18/C8/C4/phenyl range
- COSMOSIL(exclusive),SilicaOne Silica
- PolymerOne polymers、JNC Cellufine、gel media
- Particle size, pore size and bonded phase are customizable, and after screening move straight tocustom supply
DAC Line, 50–300 mm
Our own dynamic axial compression packing line spans the full range of diameters from bench confirmation to pilot scale-up, so wherever a method stops and wherever it is validated, it happens within the same equipment logic.
- An efficiency report is issued after packing (plate number, asymmetry factor, reduced plate height h)
- SupportColumn Packing ServiceandDAC packing support
- Scale-up is calculated on constant bed height and linear velocity, in proportion to cross-sectional area
- paired withDAC Packing Problem Diagnosisan experience base
A Complete Analysis and Characterization Platform
From HPLC to UPLC to GC, purity, impurity profile and residual solvent are all handled in house. Every time a process parameter changes, the analytical result comes back the same day, without waiting on an outside laboratory.
- HPLC (UV / DAD) — quantifying purity and impurity profile
- UPLC — high-resolution fast gradient scanning and screening
- GC — residual solvents and volatile components
- packing stations and efficiency evaluation, pluschromatography calculators
A Technical Team with Hands-On Production Experience
Projects are taken on jointly by a research team with a long background in chromatographic separation and a peptide synthesis and purification team with real production experience. The proposal does not stay on paper: it can be run in the reactor and its cost can be worked out.
- Solid-phase peptide synthesis and crude peptide quality diagnosis
- Designing orthogonal purification routes across RP, IEX and HILIC
- Impurity localization and its interface withpreparative separation
- On-site column packing, commissioning and troubleshooting support
Five steps: from molecular properties to scale-up feasibility
Each step has a defined input, action and output, so the customer sees data at every stage rather than waiting until the end of the project for a single report.
Target molecule property assessment
Establish molecular weight, hydrophobicity, isoelectric point and charge distribution, solubility, and the pH and thermal stability windows, and map known impurity sources (synthetic route, deprotection, degradation). This step governs every subsequent choice of chromatographic mode.
Media and column screening
Candidate media are drawn straight from the in-house library and screened in parallel at analytical scale: substrate (silica / polymer / cellulose / gel), bonded phase, pore and particle size, endcapping and pH tolerance — compared in one pass rather than tried one at a time.
Mobile phase and gradient optimization
Conditions are explored around the organic system, buffer and ion-pairing reagent, pH, column temperature, gradient slope and linear velocity, using UPLC to locate the window quickly and HPLC to reproduce and confirm it.
Balancing yield against purity
Loading is stepped up and the fraction-cutting strategy optimized to define the trade-off between purity, yield and solvent consumption, with the cut points fixed against the customer's actual quality standard rather than chasing maximum purity.
Scale-up feasibility validation
On our own 50–300 mm DAC line, values are calculated and then measured on the principle of constant bed height and linear velocity with cross-sectional area scaling, checking pressure drop, efficiency and batch reproducibility, and identifying scale-up risks with corresponding contingencies.
Media available for immediate use at the screening stage
All the systems below are our own products or ones for which we are master or exclusive distributor, so they are issued from stock during screening with no need to seek quotations upstream. Once the route is fixed, the transition to volume supply or custom bonding is seamless.
| Chromatographic mode | Media available | Typically used for |
|---|---|---|
| Reversed phase (RP / IP-RP) | Daisogel C18 / C8 / C4 / Phenyl、COSMOSIL、SilicaOne | Peptides, oligonucleotides, small-molecule API polishing |
| Polymer reversed phase | PolymerOne PS-DVB series | Strongly acidic or alkaline systems that silica cannot tolerate |
| Normal phase / flash | Daisogel spherical and irregular silica, FLASHONE columns | Crude fractionation of natural products, synthetic intermediates |
| Ion exchange / affinity | JNC Cellufine Cellulose Media | Proteins, polysaccharides, biomacromolecules |
| Gel filtration (SEC) | Gel media (dextran / acrylamide based) | Desalting, separation of aggregates and small molecules |
| Residual metal removal | CleanM metal scavenger silica | Catalyst residues, ICH Q3D elemental impurities |
Screening is not confined to a single mode. For polar compounds, isomers and hard-to-separate impurities, we look first at orthogonal combinations (IEX → RP, RP → SEC) rather than grinding a gradient indefinitely on one column.Pharma & Biopharma Solutions and oligonucleotide solutions sets out a fuller framework for mode selection.
DAC line, 50–300 mm: no need to validate the method elsewhere
We operate our own dynamic axial compression line, so everything from bench confirmation to pilot scale-up happens in one system. The table below gives the geometric relationships at each diameter for a 25 cm bed height as an example; the actual bed height is set per project.
| Column ID | Cross-sectional area | Bed volume (25 cm) | Scale factor vs. 50 mm | Typical role |
|---|---|---|---|---|
| 50 mm | 19.6 cm² | ≈ 0.49 L | 1× | Bench method confirmation |
| 100 mm | 78.5 cm² | ≈ 1.96 L | 4× | Process reproduction and initial scale-up |
| 150 mm | 176.7 cm² | ≈ 4.42 L | 9× | Pilot batch validation |
| 200 mm | 314.2 cm² | ≈ 7.85 L | 16× | Pilot scale-up / small-batch sample supply |
| 300 mm | 706.9 cm² | ≈ 17.7 L | 36× | Commercial feasibility validation |
From Molecule to Bead: Two Loops Closed in Parallel
The speed of process development depends on the loop time from changing a parameter to getting a result. We track the purity and impurity profile of the target molecule by HPLC / UPLC / GC while simultaneously tracking bead quality by SEM, elemental analysis and laser particle sizing — both loops closed in house, with no waiting on outside reports.
| Platform | Role in process development |
|---|---|
| HPLC（UV / DAD） | Purity quantification, impurity profile tracking, peak purity assessment, method validation (specificity / linearity / repeatability) |
| UPLC | High-resolution fast gradient scanning, completing parallel screening across multiple media and systems in a short time |
| GC | Residual solvents, volatile components and confirmation of solvent removal |
| Packing and efficiency evaluation | Assessment of plate number N, asymmetry factor As and reduced plate height h — the column is confirmed acceptable before the process is run |
| Scanning electron microscopy (SEM) | Direct assessment of bead morphology, sphericity, surface pore structure and fracturing |
| Elemental analyser | Verification of bonded phase carbon load, nitrogen and sulfur content, and batch-to-batch consistency |
| Laser particle sizer (Malvern) | D10 / D50 / D90 and span, used to judge how the size distribution affects packing and pressure drop |
Half of whether a medium performs is written into the bead's own morphology, carbon load and size distribution. These three instruments let us see the medium clearly at the screening stage, rather than looking for the cause after a packing has failed.
What You Receive Is a Reproducible Process, Not a Conclusion
The two deliverables — a process parameter package and a method validation report — are written so that the customer's engineering team can reproduce the process on their own equipment without coming back for details.
Process parameter package
- Recommended medium and column specification (substrate / bonded phase / pore size / particle size)
- Mobile phase composition, gradient table, flow rate and column temperature
- Loading, loading solvent and fraction-cutting rules
- Regeneration, cleaning and storage procedures, with guidance on medium lifetime
- Scale-up conversion table and recommended parameters for the target diameter
Method validation report
- Screening records and comparison of candidates, including those excluded and why
- Representative chromatograms with peak assignments
- Purity / yield / loading relationship data
- Method robustness and sensitivity analysis for key parameters
- Efficiency report and scale-up risk list
When it makes sense to hand the process to us
Establishing a purification route for a new molecule
You have only crude material and a quality standard, and need to establish the chromatographic mode, medium and conditions from scratch and obtain a reproducible process quickly.
An existing process costs too much or yields too little
The method runs, but media consumption is high, solvent volumes are large and yield will not improve; the parameters need rebalancing without sacrificing quality.
Works at bench scale, breaks down on scale-up
Well resolved on an analytical column, but tailing, peak stacking and batch variation appear on a preparative or DAC column; the cause has to be found on real equipment.
A hard-to-separate impurity is holding up the project
Isomers, deletion sequences, oxidation or deamidation products with properties close to the main peak, requiring an orthogonal combination of modes or the support ofImpurity Preparation.